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What is the difference between an Artificial Pacemaker, Implantable Cardioverter Defibrillator (ICD) and a Left Ventricular Assist Device (LVAD)?
• Pacemakers and Implantable Cardioverter Defibrillators (ICDs) are used to treat arrhythmias — a condition of heart rhythm problems that occurs when the electrical impulses that coordinate your heartbeats don't function properly, causing your heart to beat too fast, too slow or irregularly.
• The Left Ventricular Assist Device (LVAD) helps maintain the pumping ability of your heart.
The heart's "natural" pacemaker is called the sinoatrial (SA) node or sinus node. It's a small mass of specialized cells in the top of the heart's right atrium (upper chamber). It makes the electrical impulses that cause your heart to beat.
A chamber of the heart contracts when an electrical impulse moves across it. For the heart to beat properly, the signal must travel down a specific path to reach the ventricles, the heart's lower (pumping) chambers. The natural pacemaker may be defective, causing the heartbeat to be too fast, too slow or irregular. The heart's electrical pathways also may be blocked.
In this case your doctor may recomend:
An "artificial pacemaker", a small, battery-operated device that helps the heart beat in a regular rhythm. Some are permanent (internal) and some are temporary (external). They can replace a defective natural pacemaker or blocked pathway.
A pacemaker uses batteries to send electrical impulses to the heart to help it pump properly. An electrode is placed next to the heart wall and small electrical charges travel through the wire to the heart.
Most pacemakers are demand pacemakers. They have a sensing device. It turns the signal off when the heartbeat is above a certain level. It turns the signal back on when the heartbeat is too slow.
Implantable Cardioverter Defibrillator (ICD)
An Implantable Cardioverter Defibrillator (ICD)
is a pacemaker-like device that continuously monitors your heart rhythm. If it senses there is a problem with the rhythm that is not too serious it delivers a series of painless electrical impulses to correct the heart rhythm.
If this doesn't work, or a more serious heart rhythm problem is detected, the ICD will deliver a small electrical shock, known as cardioversion. If this doesn't work, or a very serious problem is detected, the device will deliver a more noticeable shock to the heart, known as defibrillation.
ICDs are generally used in people at high risk of serious rhythm problems in the ventricles (lower chambers) of their heart, the primary cause of sudden cardiac death. In certain patients groups with heart failure, these devices have been shown to prolong survival. Doctors frequently choose to combine an ICD with a CRT in the same device. In this case, the device is termed a CRT-D.
• Read about VADs below
HeartWare Left Ventricular Assist System by HeartWare International Inc.
HVAD® pump in pericardial space
The HeartWare's Ventricular Assist System
is designed to help a patient's weakened heart pump blood throughout his or her body by removing blood from the left side of the heart and pumping the blood into the aorta (the large blood vessel that carries blood from the heart to the rest of the body).
The pump is designed to rest inside the patient's chest. Two small motor stators inside the pump housing cause an impeller within the device to rotate, pumping blood through the system. A driveline (cable) exits the patient's skin and connects the implanted pump to an externally worn controller. The controller is powered by a battery pack, which incorporates two batteries or one battery plus an adaptor connecting to a wall or vehicle electricity outlet. The controller operates the pump and is designed to provide the patient with signals and alarms concerning the operation of the system. The controller and batteries are contained in a carrying case that is designed to be worn either on the patient's belt or over the shoulder....read more
HVAD® pump showing impeller
At the core of the HeartWare Left Ventricular Assist System is a small implantable centrifugal blood pump called the HVAD® Pump. The pump is designed to draw blood from the apex of the left ventricle and to propel it through an outflow graft connected to the patient's ascending aorta. The device is capable of generating up to 10 liters per minute of blood flow.
With a displaced volume of only 50cc, the HVAD® pump is designed to be implanted in the pericardial space, directly adjacent to the heart. Implantation above the diaphragm is expected to lead to relatively short surgery time and relatively quick recovery.
The HVAD® Pump has only one moving part, the impeller, which spins at rates between 2,000 and 3,000 revolutions per minute. The impeller is suspended within the pump housing through a combination of passive magnets and a hydrodynamic thrust bearing. This hydrodynamic suspension is achieved by a gentle incline on the upper surfaces of the impeller blades. When the impeller spins, blood flows across these inclined surfaces, creating a "cushion" between the impeller and the pump housing. There are no mechanical bearings or any points of contact between the impeller and the pump housing....continue reading
HeartWare® Ventricular Assist System
HeartWare Receives FDA Approval for HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation for Patients with Advanced Heart Failure.
November 20, 2012
First full-support, miniaturized ventricular assist device approved in U.S. designed to be placed in the pericardial space.
HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. Today, more than 2,500 advanced heart failure patients globally have received the HVAD® pump......read more
HeartWare International Inc. News Releases
Click on Image for a complete list of HeartWare International, Inc. News Releases
About HeartWare International, Inc. (Nasdaq: HTWR)
(HeartWare) is a medical device company developing a family of implantable Left Ventricular Assist Devices ("LVADs") for the treatment of advanced heart failure.
The HeartWare Ventricular Assist System features a miniaturized implantable centrifugal pump capable of producing up to 10 liters per minute of blood flow. The pump is designed to be implanted above the diaphragm, directly adjacent to the heart, thereby avoiding the abdominal surgery generally required to implant competing devices.
HeartWare has completed enrollment of a 50-patient international clinical trial. The Company received CE Mark approval for the System in January 2009 and the System is now commercially available in Europe.
In the United States, the System is the subject of an ongoing Bridge-to-Transplant clinical trial under which HeartWare enrolled 140 patients at 30 participating centers. Patient follow-up for that study is expected to conclude in August 2010, with subsequent PMA submission to the FDA. HeartWare is also seeking to commence a Destination Therapy clinical trial in the United States.
HeartWare's corporate headquarters are in Framingham, Massachusetts. The Company's operating and manufacturing activities are based in Miami Lakes, Florida.
The DLR Heart – The Revolutionary Alternative to Heart Transplant and Complete Ventricular Systems.
The DLR Heart is a key DUALIS developement project. This system has been designed for the long-term support of people with severe cardiac insufficiency. This thoroughly novel technology should give doctors and patients a viable alternative to heart transplantation and complete ventricular systems.
DLR Heart, an overview:
• Dual chamber system, univentricular and biventricular assistance • Low energy consumption • Efficient support through active control • Long lifespan • Pulsating flow
Better Quality of Life for Heart Patients
A heart transplant is usually the last option for the approx. 40,000 patients who are today waiting for a donor heart. However, only about 4,500 hearts can be transplanted per year (USA/EUROPE). Artificial ventricular systems could be an effective solution. The devices currently available are often applicable as a support system for the left ventricular chamber only and considerably limit the patient’s quality of life.
The development of our innovative, totally implantable DLR Heart for Ventricular Assistance will overcome these limitations. The target lifespan of several years and the wireless power supply allow patients a speedier return to everyday life and maximum quality life in the long term.
Investigational Device Only.
The World’s Most Gentle System for Lasting Ventricular Assistance.
The DLR Heart has a novel bi-chamber technology which enables the patient to keep his/her own heart. The fully implantable ventricular assist system can support both chambers of the heart (biventricular) simultaneously and so renders the transplant of an artificial heart or substitute heart unnecessary.
High Tech from Space Research.
The hydraulic drive unit technology of the DLR Heart is based on the long-standing development of lightweight construction robots. The mechanical load of the hydraulic components is minimised by liquid storage, and a practically unlimited lifespan is possibe. The pumping chambers of the system are flow optimized, have been improved and further developed in numerous studies. This considerably reduces the risk of thrombus and plaque. Innovative nanocoatings will, in the future, provide for even better biocompatibility.
Wireless Energy Supply for Full Freedom of Movement Round-the-Clock.
The DLR Heart is powered by our innovative power transmitter system which allows a wireless transfer of data and power to implants. With this, wiring is no longer necessary in the abdominal wall. The patient can move freely.
The Arrow LionHeart™
Torso of man's body with Arrow LionHeartTM implanted. Click on Image for more information
The Arrow LionHeart™
is the first fully implantable heart assist device. The Arrow LionHeart™ is not an artificial heart. It is a "heart helper" or left ventricular assist system (LVAS) for patients suffering from severe heart failure who are not eligible for a natural heart transplant.
The Division of Artificial Organs at Penn State College of Medicine, Walter Pae, Jr. M.D.pioneered the development of the Arrow LionHeart™ and has collaborated closely with Arrow International, Inc. in preparing the device for clinical use.
Under the direction of Dr. Walter Pae, Jr., professor of surgery at Penn State Milton S. Hershey Medical Center, clinical trials began in Europe in October 1999 and were recently completed. U.S. Trials began in February 2001 and continue today.
was implanted for the first time – anywhere in the world – by Prof. Reiner Körfer, MD, Dr. h.c. and his team of specialists at the Clinic for Thoracic and Cardiovascular Surgery within the Heart and Diabetes Center NRW, Bad Oeynhausen, on 26th October 1999.
Unlike previous assist devices, the LionHeart™ system, developed by the American company Arrow International Inc., has no connection to an external power supply. The battery is sewn under the skin and is recharged from the outside by means of induction. This cable-free (and thus wound-free) power supply considerably reduces the risk of infection.
The energy storage system within the body functions for 45 minutes without recharging, giving the wearer time to remove the charger belt and take a shower or a swim. Since 1999 a total of 10 patients have received this fully implantable total artificial heart in Bad Oeynhausen.
The Levacor VAD™ by WorldHeart
The Levacor VAD™
The Levacor VAD™ by WorldHeart
is an advanced, next-generation rotary blood pump intended for adults who suffer from late-stage heart failure. Unlike the initial generation of rotary pumps with mechanical or blood-lubricated bearings, the Levacor VAD™ is a compact, centrifugal pump with an impeller that is completely magnetically levitated.
Full magnetic levitation eliminates wear mechanisms during operation of the pump. It also permits greater clearances and more optimized blood flow around the impeller while eliminating dependence on the patient's blood for suspension. The Levacor VAD's levitation technology employs a unique combination of passive and single-axis active control, resulting in the simplest levitation system possible.
Using this and other innovative technologies, the Levacor VAD™ system is designed to deliver unique benefits
High Margin of Safety
Enhanced Blood Compatibility
Multi-Year Reliability and Durability
Easily exchangable wearables
Wide Range of Applicability
Indications: Transplant, Recovery, and Destination
WorldHeart's Novacor® LVAS was approved for use in North America, the European Union and Japan. Sales were discontinued in 2008.
WorldHeart's Novacor® LVAS
is an implanted, wearable system that provides long-term pulsatile circulatory support for patients with life-threatening heart failure. Since 1984, the Novacor® LVAS has been implanted in more than 1,800 patients, predominantly for a Bridge-To-Transplant indication. Sales of the Novacor LVAS were discontinued in 2008.
The field experience and expertise gained by clinical use and commercial sale of the Novacor LVAS in North America, Europe and Japan has been applied to the development of WorldHeart's next-generation rotary blood pumps: Levacor VAD (Above), the MIVAD and the PediaFlow VAD.
Founded in 1996, WorldHeart is a public company headquartered in Salt Lake City, Utah (USA), with additional offices located in Oakland, California (USA), and in Herkenbosch (The Netherlands). Its registered office is Delaware, USA.
WorldHeart's VADs are used to support the left ventricle, which takes oxygenated blood from the lungs and pumps it to and through the tissues and organs. As a result of this heavy and constant demand, the left ventricle does most of the pumping work and therefore fails more often. Long-term support of the left ventricle alone is estimates to serve more than 80% of eligible patients. In this application, these devices are called LVADs (Left Ventricular Assist Devices).
WorldHeart's VADs have been successfully used for the following indications for heart failure patients:
Framingham, Mass. and Salt Lake City, Utah, August 2, 2012 – HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced the closing of the acquisition of World Heart Corporation following the approval of the transaction today by World Heart stockholders.
The Impella Devices, AB5000, AbioCor & More by Abiomed
The IMPELLA Devices
are minimally invasive catheter pumps that can support the heart with up to 5.0 liters blood per minute. The pumps can be implanted percutaneously, via a cut-down, or in the OR.
The Impella 2.5 Cardiac Assist Device is a minimally invasive, catheter-based cardiac assist device designed to:
Directly unload the left ventricle
Reduce myocardial workload and oxygen consumption
Increase cardiac output and coronary and end-organ perfusion
The Impella 2.5 can be inserted into the left ventricle in a Cath Lab via a standard guidewire through the femoral artery, into the ascending aorta, across the valve and into the left ventricle.
The tip of the catheter contains a “pigtail” that crosses the patient’s heart valve and rests in the left ventricle, generating flows up to 2.5 L/min.
Impella 2.5 Cardiac Assist Device Now Available to Doctors and Patients in the U.S.
June 2, 2008
The U.S. Food and Drug Administration (FDA) just cleared the Impella 2.5 Cardiac Assist Device, the world's smallest heart pump only slightly larger in diameter than a drinking straw, for immediate use. Designed for cardiac arrest and heart attack patients, it pumps up to 2.5 liters of blood per minute, and supports the heart in situations when it cannot function on its own.
Each year over a million people in the U.S. have a heart attack, according to the National Institutes of Health. Of that statistic, half of them die and many are left with permanent heart damage. As the world's smallest Ventricular Assist Device (VAD), this technology provides patients with immediate, sustained coronary perfusion when their heart is unable to do so.
Today's clearance allows Abiomed to begin selling the device for use to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the United States.
The Impella CP™
The Impella CP™
is a new percutaneous, catheter-based Impella® device. The increased flow of the Impella CP™ is delivered on the same platform as the Impella 2.5.
The pump can be inserted via a standard catheterization procedure through the femoral artery, into the ascending aorta, across the valve and into the left ventricle.
The Impella 5.0®
The World’s Smallest 5.0 L/min Heart PumpThe Impella 5.0 catheter is an intravascular microaxial blood pump that delivers up to 5.0 L/min of forward flow blood from the left ventricle to the aorta.The Impella 5.0 can be inserted into the left ventricle via femoral cut down or through the axillary artery. The Impella 5.0 pump goes through the ascending aorta, across the valve and into the left ventricle.
Micro-Axial Blood Pump
Delivers forward-flow from the left ventricle to the aorta
9 Fr catheter-based platform
21 Fr micro-axial pump
Minimal bedside support
Single Access Point
Minimally invasive placement through a single artery and into the left ventricle
Several options for access site
No septal puncture
No priming/no blood outside the body
Multiple large bore cannulae not required
The Impella® LD pump
is a minimally invasive, catheter- based cardiac assist device designed to directly unload the left ventricle, reduce myocardial workload and oxygen consumption while increasing cardiac output, coronary and end- organ perfusion.The Impella LD can be inserted into the left ventricle via open chest procedures. The Impella LD pump is inserted through the ascending aorta, across the valve and into the left ventricle.
Micro-Axial Blood Pump
Delivers forward-flow from the left ventricle to the aorta
is vacuum assisted technology with clear housing to allow clinicians a view into the device. Unlike other ventricular assist systems that can require multiple drivers for a single patient, patients on the AB5000 Ventricle require only a single driver – regardless of condition.
The AB Portable Driver is designed to allow patients to leave their hospital rooms and walk within the hospital and on hospital grounds. Multiple studies have shown that patient ambulation, or walking, greatly assists the recovery process. The ease of use and transport capability of the AB Portable Driver makes it an important option for both regional and local cardiac centers.
The AB Portable Driver
The AB Portable Driver
Increased Mobility and Versatility – Without Compromise
The AB portable was designed to retain all functionality of the AB5000 Console for AB5000 Ventricle patients. The AB portable console provides biVAD support with adjustable vacuum controls and independent weaning controls. The AB portable is able to support patients from surgical implant through weaning to explantation.
Lightweight, Compact, Portable
The AB Portable Driver weights 18.9 lbs. Configuring the portable driver with its AB Power Pack and small mobile cart, allows for easier, independent patient ambulation, in-hospital transfer, or land/air transport.
Advanced compressor and proportional valve technologies produce an inherently quiet design which minimizes disruption to the patient and their environment.
AbioCor Implantable Replacement Heart
is the world's first completely self-contained replacement heart. A product of three decades of research, development and testing, the AbioCor is central to ABIOMED's mission to make real the day when heart failure need not mean the end of life or the ability to enjoy life. AbioCor was designed to fully sustain the body's circulatory system.
The AbioCor, which is FDA approved under a humanitarian device exemption (HDE), is intended for severe chronic heart failure patients whose normal heart function cannot be restored, are not eligible for transplant, and, according to Abiomed, "have no other treatment options."
Although AbioCor is considered to be an engineering marvel, it has a very limited market due to its relatively short life. Next-generation AbioCor II, which is in development, is 30% smaller than AbioCor I and is anticipated to have a life expectancy approaching five years.
NOTE: The AbioCor is NOT CE marked and is NOT available in Europe at this time.
Abiomed is a global technology leader focused on RECOVERING HEARTS AND SAVING LIVES. (Website)
The Company's portfolio of heart support and recovery products and services offer healthcare professionals an array of choices across a broad clinical spectrum. From the catheterization lab to the surgical suite, together with interventional cardiologists and surgeons, Abiomed is dedicated to providing the most advanced medical technologies to heart patients, with the ultimate goal of heart recovery and improved quality of life.
Abiomed was founded in 1981 and is the only company in the world with exclusive labeling on ventricular assist devices for all potentially recoverable heart failure indications. The Company develops, manufactures and markets advanced medical technologies designed to assist or replace the pumping function of the failing heart.
Abiomed is the global leader for products in the acute heart failure market and ships more ventricle assist devices (VADs) than any other company in the world.
The Company is focused on expanding its global distribution, fueling innovation and new products to broaden the Company's product portfolio to become the world's circulatory care leader.
Corporate Headquarters: Danvers, Massachusetts
European Division: Aachen, Germany
Number of Employees: 300+
The Procyrion catheter deployed ventricular assist device (CVAD)
The Procyrion System
The Procyrion catheter deployed ventricular assist device (CVAD) is deployed percutaneously within the descending aorta and held axiosymmetric within the aorta by a self-expanding strut fixation system. Once the pump is activated, a micro-motor and impeller pulls fluid from the heart and restores body hemodynamics. The pump can then be retrieved through a catheter-based procedure when the heart has had a chance to heal.
Restores hemodynamics through continuous aortic flow augmentation
Deployed and retrieved in a catheter lab
Unloads the heart without invasive surgery and damage to the heart muscle
Reduced stroke risk
High perfusion of the carotid and coronary arteries (No STEAL phenomenon)
High ambulatory patient mobility
Potential to treat less sick patients earlier in the heart failure spectrum
The HeartMate II and The HeartMate XVE by Thoratec
HeartMate II® Left Ventricular Assist System
HeartMate II® Left Ventricular Assist System
Life Restored. Proven Alternative for Advanced Heart Failure.
The HeartMate II, approved by the Federal Drug Administration in January 2010 for use in patients who not only are waiting for a heart transplant, but who want to live with the VAD for the rest of their lives is Thoratec's first-line intermediate-to-chronic left ventricular assist device for Bridge-to-Transplantation and Destination Therapy (i.e. long term support for patient ineligible for cardiac transplantion).
Designed to dramatically improve survival and quality of life, the HeartMate II was developed with the goal of providing several years of circulatory support for a broad range of advanced heart failure patients. Its small size and quiet operation make the HeartMate II suitable for a wider range of patients, including women and those of smaller stature*. With product attributes specifically developed to minimize the risk of complications, the HeartMate II is exceptionally durable, dependable, and thromboresistant.
It offers a range of features and benefits: •Implantation requires a less invasive surgical procedure •Relative ease of management; completely wearable system •Low-dose anticoagulation regimen •Improvement of hemodynamics prior to cardiac transplantation can help optimize long-term outcomes
HeartMate® XVE Left Ventricular Assist Device
HeartMate® XVE Left Ventricular Assist Device
The Only Intermediate-to-Chronic LVAD Requiring No Systemic Anticoagulation The HeartMate XVE (also referred to as HeartMate I) is one of the most widely used left ventricular assist devices in the world. With its low thromboembolic risk, the HeartMate XVE can be used for either Bridge-to-Transplantation or Destination Therapy (chronic support for those ineligible for cardiac transplantation.)
It offers a range of features and benefits: •Provides complete unloading of the left ventricle in refractory heart failure patients •Low proven stroke rate Does not require systemic anticoagulation •Improves outcomes of heart transplantation compared to continuous inotropic infusions
For more than 30 years, Thoratec has been committed to developing advanced medical technologies to improve patient survival and quality of life. (Website)
Thoratec provides the broadest mechanical circulatory support portfolio to treat the full range of clinical needs. From acute to chronic heart failure, Thoratec offers proven device-based therapies to provide a new beginning for patients and their families. Additionally, the company's wholly-owned subsidiary, International Technidyne Corporation (ITC), manufactures and sells a wide range of equipment for hemostasis management and point-of-care testing. Thoratec employs more than 1,000 people worldwide. We are based in Pleasanton, California, with facilities in Burlington, Massachusetts; Rancho Cordova, California; Edison, New Jersey; and Cambridgeshire, UK.
CentriMag Blood Pump & PediVAS Blood Pump by Levitronix
CentriMag Blood Pump
The Levitronix CentriMag
The CentriMag Blood Pump is a bearingless polycarbonate pump designed for extracorporeal blood pumping applications. The CentriMag Blood Pump represents a new generation of blood pumps that provide hemodynamic support with minimal blood trauma. Unlike conventional devices, the CentriMag® Blood Pump does not contain seals or bearings which are components known to cause hemolysis and promote thrombus formation.
The Levitronix CentriMag Blood Pump has been used as a ventricular assist device for a wide range of patients worldwide. Key applications include:
•Post-cardiotomy failure (failure to wean from bypass) •Bridge to transplant •Bridge to recovery •Bridge to a long-term device •RVAD support with a long-term LVAD •Respiratory (Veno-venous) ECMO •Cardiac (Veno-arterial) ECMO
In addition to use as a ventricular assist device, the CentriMag Blood Pumping System has successfully supported adult and pediatric patients suffering from respiratory and cardiovascular disorders as part of an extracorporeal membrane oxygenation (ECMO) circuit
PediVAS Blood Pump
The Levitronix PediVAS Blood Pump
The PediVAS blood pump was developed to fill a growing need among neonatal centers for a reliable 30-day centrifugal blood pump. The PediVAS blood pump is a neonatal version of the CentriMag blood pump which has been used to successfully to treat thousands of patients.
The PediVAS blood pump has ¼” tubing connectors which allow the use of small cannulae or small oxygenators. The device is ideally suited for neonatal patients who require a maximum blood flow of less than 1.5 LPM.
The PediVAS System is based on the same bearingless technology as the CentriMag System. The PediVAS Pump is CE Mark approved for 30 days of use, and therefore, the PediVAS Blood Pump has the longest intended duration of use of any pediatric plastic blood pump available worldwide.
The priming volume of the PediVAS Pump is only 14 ml making it ideal for VAD or ECMO circuits. The PediVAS blood pump is operated by the same hardware as the CentriMag blood pump, and requires only one different component, a neonatal flow probe to enable the system to be used for the smallest patients.
The hardware is comprised of three major components: The drive console which allows the operator to control the pump, the motor which generates the magnetic fields that elevate and rotate the pump, and a flow probe which measures the flow delivered to the patient. Levitronix has two generations of Primary Consoles....read more
LEVITRONIX is the worldwide leader in magnetically levitated Bearingless Motor technology, specializing in supplying blood pumps to the medical community and ultra-pure fluid handling devices for Microelectronics, Life Science and Industrial applications.
Their patented technology permits the motor and magnetic bearing to be combined into a single unit with products that achieve maximum reliability, long life, and the ability to pump precious fluids in the harshest of environments.
LEVITRONIX offers the ideal solution for those applications that demand contaminant-free pumping, mixing or fluid control for extended periods in a highly reliable fashion.
LEVITRONIX is headquartered in Waltham, Massachusetts and in Zurich, Switzerland. Levitronix is a wholly owned subsidiary of Pharos, LLC.
supports extra large adults to pediatric patients as small as 18 kg. It provides smooth, gentle blood flow from 1-10 L/min. For weaning patients, the HeartAssist 5 provides precise blood flow as low as 1 L/min.
have received CE Mark approval for commercial distribution within the European Union for bridge-to-transplantation, destination therapy, and pediatric indications for use.
The bridge-to transplantation indication was originally CE Marked in April 2001 for the DeBakey VAD® and the additional CE Mark indications approval for destination therapy and the DeBakey VAD® Child pediatric indication occurred during the second quarter of 2004. Most recently, both the DeBakey VAD® and the DeBakey VAD® Child Systems completed a design and clinical experience evaluation of the last 5 years of commercial experience for the purpose of re-certification of our CE Mark by our Notified Body.
The new CE Mark Certification was issued by our Notified Body in 2006 and is valid through April 27, 2011. MicroMed has commercial distribution of the DeBakey VAD® and the DeBakey VAD® Child to all countries of the European Union, Switzerland and Turkey.
The DeBakey VAD® Systems are made up of four major components:
•The Pump •The Data Acquisition System •The Patient Home Support System •The Controller and VADPAK®.
This illustration shows the individual components of the pump
The DeBakey VAD® Pump System includes the titanium pump and inlet cannula, the percutaneous cable, the flow probe, and the outflow graft. The pump is attached to a titanium inlet cannula that is placed into the left ventricle. A graft is connected to the pump outlet and attached to the aorta.
The inducer/impeller is the only moving part of the pump. It has six blades with eight magnets hermetically sealed in each blade. The inducer/impeller spins at speeds between 7,500ø12,500 RPM and is capable of generating flow in excess of 10 liters per minute.
The components are fully enclosed in a titanium flow tube that has been hermetically sealed. The pump is driven by a brushless, direct current (DC) motor stator that is contained in the stator housing. The pump is attached to a titanium inlet cannula that is placed into the left ventricle. A graft is connected to the pump outlet and attached to the aorta.
CDAS (Clinical Data Acquisition System)
CDAS (Clinical Data Acquisition System)
The DeBakey VAD® Clinical Data Acquisition System is used to monitor the patient and adjust the operating parameters of the DeBakey VAD®. It is designed for use during surgery and while the patient is in intensive care. The system provides power to the unit and is used to adjust the speed of the pump to increase or decrease blood flow. The CDAS also monitors critical patient data, including blood flow rate, speed of pump and power usage.
PHSS (Patient Home Support System)
PHSS (Patient Home Support System)
The Patient Home Support System is designed to provide primary power to the DeBakey VAD® while the patient is stationary for long periods or sleeping and may be used in the hospital or at home. In addition to providing power, it provides a battery backup and charges up to four batteries. Whether in the hospital or at home, MicroMed designed the PHSS to allow patients to sleep or rest without concern about changing batteries. The Patient Home Support System is approximately the size of a small cooler and weighs approximately 10 pounds.
The MicroMed DeBakey VAD® Controller
Controller and VADPAK
The DeBakey VADPAK
The MicroMed DeBakey VAD® Controller
operates the MicroMed DeBakey VAD® and displays key operating information about the pump including remaining battery life. The Controller also sounds an alarm in the event power is inadvertently disconnected or upon detection of unusual operating conditions. The two batteries in the VADPAK will each power the DeBakey VAD® for approximately two to four hours, giving a combined battery time of approximately six to eight hours.
The DeBakey VADPAK
The DeBakey VAD® Controller and two batteries are housed in the VADPAK, an ergonomically designed carrying case. Together, the VADPAK, Controller and batteries weigh approximately five pounds, allowing patient mobility and the ability to engage in normal, everyday activities.
About MicroMed Cardiovascular, Inc.
In 1984, Dr. Michael DeBakey and Dr. George Noon performed heart transplant surgery on NASA-Johnson Space Center (JSC) engineer David Saucier, following a severe heart attack. Six months later, Saucier returned to JSC with the desire to apply spacecraft technology to help people with diseased hearts. As early as 1987, informal meetings began with NASA engineers and Drs. DeBakey and Noon to discuss the design of a low-cost, low-power, implantable ventricular assist device (VAD). NASA began formal funding of the development of the device four years later, bringing outer space technology to inner space applications.
In 1996, MicroMed Cardiovascular, Inc. received an exclusive license from NASA to use this rotary blood pump for cardiovascular applications. MicroMed then began the development of the critical support systems that would allow the device (system) to be approved by regulatory agencies and to be utilized in lifesaving applications in humans.
European clinical trials of the MicroMed HeartAssist 5® began in November 1998 and CE Mark certification was awarded in April 2001 for both the Adult and Pediatric VADs. The Pediatric VAD received FDA approval under a Humanitarian Device Exemption in February 2004. The U.S. clinical study for the Adult VAD is currently underway.
MicroMed's world headquarters and its ISO 13485:2003 certified manufacturing facility is located in Houston, Texas. MicroMed has an international office located in Zurich, Switzerland.
Octopus® Tissue Stabilizer and Starfish® Heart Positioner by Medtronic
Octopus® Tissue Stabilizer and Starfish® Heart Positioner
Medtronic's Starfish®2 and Urchin® Heart Positioners used for Beating Heart Bypass Surgery
When your arteries cannot supply enough blood to your heart, your doctor may recommend coronary artery bypass graft (CABG) surgery. One of the most common heart surgeries in the United States, CABG surgery restores blood flow to your heart.
Approximately every 10 minutes, someone has beating heart or "off-pump" bypass surgery1. Beating heart bypass surgery is – in simple terms – bypass surgery that is performed on your heart while it is beating. Your heart will not be stopped during surgery. You will not need a heart-lung machine. Your heart and lungs will continue to perform during your surgery.
Surgeons use a tissue stabilization system to immobilize the area of the heart where they need to work.
Beating heart bypass surgery is also called Off Pump Coronary Artery Bypass Surgery (OPCAB). Both OPCAB and conventional on-pump surgery restore blood flow to the heart. However, off-pump bypass surgery has proven to reduce side effects in certain types of patients.
The challenge in beating heart CABG surgery is that it can be difficult to suture or "sew" on a beating heart. The surgeon must use a "stabilization" system to keep the heart steady.
The stabilization system consists of a heart positioner and a tissue stabilizer. The heart positioner guides and holds the heart in a position that provides the best access to the blocked arteries. The tissue stabilizer holds a small area of the heart still while a surgeon works on it.
Medtronic's Starfish®2 and Urchin® Heart Positioners are designed to position and to hold the heart to give the surgeon easy access to the blocked vessel requiring the bypass graft.
The Medtronic Octopus® Tissue Stabilizer minimizes limits the motion of a small area of the heart while the rest of the heart continues to beat normally. This allows the surgeon to perform CABG surgery without stopping your heart and without using the heart-lung machine. For more information go to Medtronic.com
Medtronic was founded in 1949 as a medical equipment repair shop by Earl Bakken and his brother-in-law, Palmer Hermundslie. Since then, they've grown into a multinational company that uses technology to transform the way debilitating, chronic diseases are treated.
Their first life-changing therapy – a wearable, battery-powered cardiac pacemaker – was the foundation for dozens more Medtronic therapies that use Their electrical stimulation expertise to improve the lives of millions of people.
Over the years, Medtronics has adapted additional technologies for the human body, including radio frequency therapies, mechanical devices, drug and biologic delivery devices, and diagnostic tools. Today, their technologies are used to treat more than 30 chronic diseases affecting many areas of the body.
The DuraHeartTM System by Terumo Heart Inc.
The Magnetically Levitated Pump sets the DURAHEART™ apart from other systems.
The DuraHeartTM Left Ventricular Assist System (LVAS)
is a third-generation rotary blood pump designed for long-term patient support. It incorporates a centrifugal flow rotary pump with a magnetically levitated impeller to pump blood from the heart around the body.
The DuraHeartTM System consists of an implantable Pump and several components that support the function of the Pump. The system is made up of seven main components which include: • Pump • Inflow Conduit • Outflow Conduit • Hospital Console • Controller • Batteries and a Battery Charger
Terumo Heart, Inc is dedicated to the innovation, introduction and advancement of products to improve the quality of healthcare for heart failure patients. Their principal focus is the development, clinical evaluation and commercialization of the DuraHeartTM Left Ventricular Assist System (LVAS). The system is designed to provide long-term circulatory support and address the shortage of donor hearts for cardiac transplantation. Combining patented magnetic-levitation and centrifugal pump technologies, the DuraHeartTM LVAS is expected to decrease complications and improve the lives of patients with severe heart failure.
Terumo Heart, Inc. is a wholly owned subsidiary of Terumo Corporation with headquarters in Ann Arbor Michigan. The team is led by Bill Pinon.
Temporary Total Artificial Heart by SynCardia Systems Inc.
*The SynCardia temporary Total Artificial Heart was formerly known as the SynCardia temporary CardioWest™ Total Artificial Heart.
The SynCardia temporary Total Artificial Heart
Patients in need of the SynCardia temporary Total Artificial Heart are often the sickest of the sick. All other treatments have failed. Both sides of their heart are failing to pump enough blood to sustain their body and vital organs are beginning to shut down.
Once implanted, the Total Artificial Heart provides the body with immediate, safe blood flow of up to 9.5 L/min through both ventricles, helping vital organs recover faster. The sooner you regain your strength, the sooner you can be listed for a donor heart.
Once stable, Total Artificial Heart patients in the U.S. are listed UNOS Status 1A and moved to the top of the transplant list until a matching donor heart becomes available. In contrast, most ventricular assist device (VAD) patients are listed Status 1A for 30 days and then moved down to Status 1B thereafter*.
Click here to read about the Freedom™ Driver System
The investigational 13.5 lb Freedom™ driver is the world's first wearable driver designed to power the SynCardia temporary Total Artificial Heart both inside and outside the hospital.
SynCardia to Host Principal Investigators' Meeting for Freedom® Portable Driver Clinical Study Jan. 25, 2011
On Jan. 31, 2011 SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, will host a Principal Investigators' meeting in San Diego for its FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom® portable driver. Weighing 13.5 lbs, the Freedom driver is the first U.S. portable driver designed to power the Total Artificial Heart both inside and outside the hospital.
In addition to the U.S. clinical study, the Freedom driver is CE approved for use in Europe. A total of 27 Total Artificial Heart patients have been supported by the Freedom driver: 10 in the U.S., 14 in Europe and three in Australia. The Freedom driver now accounts for more than 1,700 patient days (4.7 years) worldwide. In the U.S., four patients on the Freedom driver have been transplanted, and two have surpassed the study endpoint of 90 days of Freedom driver support at home....read more
Introduction to the Freedom® Portable Driver
The Freedom® driver is the world's first wearable portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
CAUTION - The Freedom driver is an investigational device, limited by United States law to investigational use.
DISCLAIMER: Freedom drivers are always shipped, stored and started up with an orange dummy battery in one battery well to engage the safety locking mechanism that prevents both batteries from being removed. Fill volume and cardiac output in this video are not representative of how the driver is used on an actual patient.
SynCardia Systems, Inc. is a private company formed in 2001 to commercialize the SynCardia temporary Total Artificial Heart.
Today, with more than 850 implants, the SynCardia Total Artificial Heart is the only FDA, Health Canada and CE approved Total Artificial Heart in the world. Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure.
Similar to a heart transplant, the Total Artificial Heart eliminates the symptoms and source of biventricular failure by replacing both failing heart ventricles. Unlike a donor heart, the Total Artificial Heart is instantly available at SynCardia Certified Centers. During the 10-year pivotal clinical study, 79% of patients receiving the Total Artificial Heart survived to transplant. This is the highest bridge-to-transplant rate of any approved device in the world*.
SynCardia’s Total Artificial Hearts, Drivers and Other Accessories are available 24/7 to World’s Top Transplant Centers via http://shop.syncardia.com/
The Jarvik 2000 FlowMaker® & The Jarvik 7 by Jarvik Heart, Inc.
Like the artificial heart,
the first ventricular assist devices (VADs) developed 25 years ago were meant to sideline the failing biological heart of a heart failure patient. These pumps were heavy, bulky things that drew blood from the left ventricle through an intake valve and moved it into the aorta at as much as 10 liters per minute — the full output of a healthy heart.
Some of the VADs made today take into account the fact that even severe heart failure patients retain partial functioning of the left ventricle: from as little as 10 percent to as much as 50 percent of its normal capacity. The tiny, valveless Jarvik 2000 FlowMaker®, developed by artificial heart pioneer Dr. Robert Jarvik, is one such design.
The Jarvik 2000 FlowMaker®
is designed to provide reliable support to the ailing heart for a decade or longer. Since accelerated tests of the pump's bearings are not practical, many more years of real-time testing are required to know whether or not the pump will achieve or exceed its design objective. Presently, the Jarvik 2000 has supported one lifetime-use patient since the year 2000, longer than any other device in the world, but its ultimate durability remains unknown. To date, not a single mechanical failure has occurred in any of the more than 200 patients who have received the Jarvik 2000.
The Jarvik 2000 pump is about the size of a C battery. Within its welded titanium shell sits a direct-current motor, a rotor supported by two ceramic bearings, and a single moving part: a small, spinning titanium impeller that pumps blood from the heart at up to 7 liters per minute. Rather than take over for the biological heart, the Jarvik 2000 augments the weakened heart's blood output to help restore a normal blood flow throughout the body.
Currently, the Jarvik 2000 does not have full FDA-approval. Investigational studies of the Jarvik 2000 are approved by the FDA, but presently only for bridge-to-transplant use. In Europe, the Jarvik 2000 has earned CE Mark certification for both bridge-to-transplant and lifetime use....continue reading
Held in the hand, the Jarvik 2000 pump is about the size of a C battery
In essence, two types of artificial hearts exist: • the total artificial heart — which is implanted after the natural heart is removed
• the ventricular assist device — which is implanted to assist the natural heart, leaving the patient's own heart in place and still functioning.
"Removing a person's heart is one of the most dramatic surgical procedures one can imagine," says Dr. Jarvik, who began developing a tiny ventricular assist device, the Jarvik 2000, in 1988. "It is no surprise that more public attention is given to replacing a heart than to assisting one. But consider this question: If you had a failing arm or leg, would you rather have the best-possible artificial limb or a device that allowed you to keep your own arm or leg?"
The question is rhetorical. But while ventricular assist devices find wider application in patients than total artificial hearts, experts view the two as complementary treatments. For example, a total artificial heart is required when an assist device will not do, as in cases of biventricular failure when both sides of the natural heart falter.
In the 60s and 70s, mechanical hearts were being developed by the National Institutes of Health (NIH) but were largely unknown to the public. Then in 1967, Christian Bernard performed the first human heart transplant, an event that generated worldwide interest: People were suddenly aware of heart replacement as a way to treat a failing heart. In 1969, Denton Cooley performed the first implantation of a temporary total artificial heart, and the primitive device sustained the patient for almost three days until a donor was found through an urgent appeal in the press. After another decade and a half of NIH-supported research, the Jarvik 7 heart became the first total artificial heart implanted as a permanent replacement for a hopelessly diseased natural heart.
The Jarvik 7 implantable artificial heart
Dr. Robert Jarvik, born in 1946 in Michigan, was a prodigy who invented a surgical stapler and other medical devices while still a teenager. While Jarvik was an undergraduate student at the University of Utah in 1964, his father needed to have surgery for his ailing heart. That family ordeal helped influence Jarvik, who went on to earn his medical degree at Utah, to turn his curiosity, inventiveness and problem-solving skills toward finding a method of saving patients with stricken hearts until they could receive a transplant.
While he wasn’t the first to develop an artificial heart, Jarvik’s 1982 creation, the Jarvik 7, was the first such device that could be implanted inside a person’s body. Jarvik continues to work toward the development of a device that could serve as a permanent replacement organ.
Though it carries the name of his colleague, Dr. Robert Jarvik, the Jarvik 7 artificial heart was invented by Dr. Willem Kolff.
It carried Dr. Jarvik’s name because it was Dr. Kolff’s policy to attach the name of the co-worker who was currently working on any particular model of artificial heart, according to Dr. Kolff’s biographer, Herman Broers, in the book “Inventor for Life” (B & V Media Publishers, 2007).
When it came time to implant a heart into a patient, Mr. Broers said, the Jarvik-7 was chosen because it had a multilayer diaphragm, designed by Dr. Jarvik, that proved crucial to the device’s success. But credit for the artificial heart belongs to Dr. Kolff.
Jarvik 7 Artificial Heart
The First Jarvik 7 Patient
In 1982 the Jarvik 7 heart became the first total artificial heart implanted as a permanent replacement for a hopelessly diseased natural heart.
At the University of Utah on December 2, 1982, William DeVries, MD implanted the Jarvik 7 total artificial heart into Barney Clark, a Seattle dentist who volunteered to undergo the pioneering procedure because he wanted to make a contribution to medical science.
Dr. Jarvik recalls that, before the surgery, Dr. Clark told doctors that he didn't expect to live more than a few days with the experimental heart, but he hoped that what the doctors learned might help save the lives of others someday.....read complete history of The Jarvik 7 total artificial heart
Jarvik Heart, Inc. is a private company that develops miniaturized heart assist devices for the treatment of severe heart failure. The company, formed in 1988, is located in Manhattan, where it conducts all development and manufacturing activities. Leon Hirsch, founder and former Chairman of United States Surgical Corporation, serves as Chairman. Robert Jarvik, MD, inventor of the Jarvik 7 and Jarvik 2000 mechanical hearts, is President and Chief Executive Officer. Marilyn vos Savant, columnist for Parade magazine, is Chief Financial Officer.
The Jarvik 2000 FlowMaker®, Jarvik Heart's successful pilot heart pump, is an investigational device used in the United States to support patients awaiting heart transplants. In Europe, the Jarvik 2000 has earned CE Mark certification for both bridge-to-transplant and lifetime use. As an investigational device, the Jarvik 2000 has been implanted in more than 200 heart failure patients with no mechanical failures, and has successfully sustained and improved the condition of patients awaiting transplants, as well as those who have chosen the device for lifetime use.
INCOR®, EXCOR® and EXCOR® Pediatric by Berlin Heart
The INCOR® blood pump
is the implantable VAD system made by Berlin Heart. In this system, the pump is implanted directly next to the heart and connected to the heart using short cannulas. The pump is driven electrically. Batteries are used to supply the power and are connected to the pump via a cable. The batteries and control unit are stored in a bag which can be worn comfortably like a belt.
* The INCOR® blood pump is not approved for use in the US
INCOR Snap In Connector
The necessary power to drive the pump is supplied through a cable inserted under the skin on the patient's right side. The cable is connected to a small control unit which monitors and regulates the whole system. A main power pack and a back up power pack are attached to the control unit and supply INCOR® with sufficient electrical current.
INCOR® generates a steady blood flow which, in combination with the residual activity of the native left ventricle, leads to reduced pulsatility for the patient. The blood contact surfaces of INCOR® are coated with Carmeda®BioActive Surface.
Tilting disc – approved and reliable for long-term applications
EXCOR® Blood Pumps – handmade transparent marvel
Every EXCOR® blood pump consists of a transparent polyurethane housing that is divided into one air chamber and one blood chamber by a three-layer membrane. Graphite between the membranes helps to minimize friction.
The membrane on the blood side merges without a seam into the surface of the housing. A specially produced CARMEDA® coating is plated on the slick, flow-optimised blood contact surface. In- and outflow sockets, which are made of polyurethane and bear titan connectors for the connection of the cannulas, lead from the blood chamber to the in or outlet cannulas.
On the air side of the membrane lays the connection for the pneumatic driving tube. The de-airing is effected through the de-airing socket.
Polyurethane valve. Operates soundless
Pump valves: tilting-disc or polyurethane?
Mechanical valves in the sockets ensure an adjusted blood flow. The blood pumps are available with two different types of valves:
• Tilting disc – approved and reliable for long-term applications • Polyurethane valve. Operates soundless
Selection of EXCOR® Pediatric Blood Pumps
The Berlin Heart EXCOR® PediatricBlood Pumps – the paracorporeal ventricular assist device
EXCOR® Pediatric has been specially developed for children, infants and even babies. This has been made possible by the wide variety of blood pumps and cannulas we have to offer.
EXCOR® Pediatric is a paracorporeal, pulsatile ventricular assist device, or VAD for short. Paracorporeal means that the actual blood pumps are located outside of the body, and are connected to the heart and blood vessels via cannulas.
EXCOR® Pediatric can be used to support one ventricle (left-sided / LVAD or right-sided / RVAD) or both ventricles (bilateral / BVAD).
The system is used successfully as short, medium and long-term cardiac support. EXCOR® is often used as a bridge until heart transplantation is performed or the heart has recovered. EXCOR® has also been used as an alternative to a heart transplant in some patients.
Since its first use in 1987, roughly 2,000 patients have been supported with the EXCOR® device
In 1997 the acquisition of the paracorporeal device with the name “Berlin Heart” (now EXCOR®) from the company Fehling Medical AG took place. The Mediport Berlin Heart GmbH Kardiotechnik was founded.
In order to make VAD patients independent from hospitals and allow them to live their life with such a device at home, a smaller, mobile driving unit was developed in 1997. The CE approval and introduction to the market followed in 1999.
In June 2002 the worldwide first implantation of the INCOR® device took place in the German Heart Centre DHZB. The CE approval for Berlin Heart INCOR® was granted after 9 months of clinical testing on March 21st 2003.
Berlin Heart Inc., a wholly owned subsidiary of Berlin Heart AG, was founded in October 2005. A US team is in place to support entry into the US market. The on-site presence ensures optimal support of the US clinics in emergency cases and allows close cooperation with the FDA...website
The Totally Implantable Artificial Heart by CARMAT SAS
implantable prosthesis and external systems
The system is based on an implantable part, a portable part and some external devices dedicated to the electrical feeding of the prosthesis and the monitoring of the patient. The implanted parts include the cardiac prosthesis and the electric connections to the power supply that is bared by the patient. This system contributes to the quality of life of the patient with more mobility and self sufficiency.
It is made on one hand of some rechargeable batteries with 4 to 5 hours of autonomy based on the currently available technologies. A second generation, in a final stage of research, should relieve the patient of the burden of recharging the batteries, as the autonomy will exceed 12 hours.
On the other hand, a monitoring waist box should provide the patient with useful information and relay the telediagnosis data to the hospital for proper monitoring of the patients with implanted artificial hearts. This 24/7 monitoring service is based on the technologies developed for pacemakers. It monitors internal data related to the prosthesis as well as physiological data originating from the patient. The electrical transfer from the batteries to the prosthesis shall be achieved through a post auricular plug or an induction system.
Those systems should prevent the infections due to percutaneous cables. Some external equipments complete this system: a monitoring console in intensive care units shall provide the surgeon with a detailed status of the prosthesis and measured physiological parameters, a battery charger and various connectors to household or cars electrical plugs.
Two motor driven pumps (A) suck and inject alternatively a fluid in the ventricular cavities (B) moving the membrane (C)… When the hydraulic compartment is emptied, the membrane sucks the blood inside the ventricle: Diastole (D) - When it is filled, the membrane pumps the blood in the arteries: Systole (E). Biological admission (D) and ejection (E) valves ensure that the blood only flows in one direction.
The prosthesis works like a natural heart and is hydraulically activated;an intermediary liquid is used to push the blood into the bloodstream. There are two times in the heart rate: the diastole when the ventricles are filled with blood and the systole when the blood is ejected in the main vessels. The prosthesis is composed of 2 ventricular cavities, left and right, each being separated in 2 volumes with a flexible membrane, one for the blood and the other one for the activating liquid. This membrane reproduces the visco-elastic nature of the cardiac muscle and acts accordingly with the blood and pushes it during the contraction.
Two miniature motor driven pumps forward the activating liquid towards the ventricles, generating the systole or by reversing the rotation, towards the external bag, during the diastole. Electronic devices regulate the prosthesis according to the patient’s needs using information generated by sensors and by a microcontroler. An external bag carries the activating liquid and pulses in unison with the cardiac rate. The internal layout of the artificial heart was regularly optimised.
Engineers worked hard on designing the different elements to keep the ventricular volume as important as possible and by doing so, to insure a good blood flow without artificially increasing the functioning frequency. The prosthesis is connected to the patient’s atrium with a special interface system allowing an easy suture on which the prosthesis is clicked.
Created in June 2008, CARMAT SAS is an innovative medtech start-up financed by TRUFFLE CAPITAL, EADS and Professor Carpentier with additional funding from the French state innovation agency OSEO.
CARMAT has developed a totally implantable artificial heart which features the left and right ventricles. Its hi-tech design seeks to make the device as similar as possible to the human heart.
The CARMAT project has been spun off of the collaboration between Professor Carpentier and EADS on implementing biomaterials and cutting-edge technologies in the artificial heart field. The project is based on 15 years of development experience.
The TandemHeart by CardiacAssist, Inc
The TandemHeart Pump acts with the THTC-EF Cannula to unload the left side of the heart
TandemHeart System Overview
The TandemHeart System is comprised of three sub-systems.
The TandemHeart Pump provides the circulating power to pull oxygenated blood from the left atrium and to return it to the systemic arterial circulation.
By way of two percutaneous access points in the patient's groin, the TandemHeart Cannula Set connects the Pump to the body.
The TandemHeart Controller provides operating power to the Pump, provides a controlled flow of lubricant to the Pump, and also provides automatic system monitoring and alarms indicating conditions that require attention.
CardiacAssist, Inc. is a Pittsburgh, PA based medical device company that develops, manufactures and markets cardiac assist devices. The company, formed in 1996, has developed a unique and proprietary platform technology to provide a short-term circulatory support system for cardiologists and cardiac surgeons.
•Deliver novel solutions that reduce health care costs and improve patient outcomes. •Provide products to the cardiologist and cardiac surgeon that address a broad range of patients less invasively and improve response time for patients to receive effective heart support in the cardiology cath lab.
While drug treatment can provide support for patients experiencing acute heart failure, some do not respond to maximum medical therapy with or without IABP (intra-aortic balloon pump) treatment. There is growing evidence to suggest that earlier deployment of mechanical circulatory support is a critical determinant of success.
Cardiologists and cardiac surgeons are therefore searching for novel treatment solutions to reduce the high incidence of morbidity and mortality for profound heart failure patients through:
•Earlier institution of circulatory support •Minimally invasive approaches
CardiacAssist, Inc. is dedicated to providing innovative products to satisfy these requirements.
VentrAssist by Ventracor Ltd
VentrAssist left ventricular assist device (LVAD)
is an implantable blood pump designed as a permanent alternative to heart transplantation for people suffering congestive heart failure. It can also provide temporary therapy while patients wait for a transplant. The device addresses the growing health problem of heart failure, for which the only cure is a heart transplant. According to Ventracor there are an estimated 11.2 million sufferers of congestive heart failure worldwide, a total that is increasing by 10 per cent each year. Only about 3000 people receive a heart transplant each year.
The VentrAssist is a blood pump that connects to the left ventricle of the heart to help its pumping function. The procedure does not require the removal of the patient's heart, and the pump allows it to rest and possibly recover. The pump has only one moving part, a hydrodynamically suspended impeller, that is designed never to wear out or damage blood cells. The device is made of titanium and the inside surfaces are diamond (carbon) coated. It weighs 298 grams and is less than 6cm in diameter, making it suitable for implant in adults and children. When implanted, the pump is connected through the abdomen by the lead to the external controller which contains the battery. The VentrAssist can be used as either a 'bridge to transplant' (BTT) therapy or 'destination therapy' (DT) device.
The VentrAssist technology is unique and when first developed was smaller, lighter and simpler than other heart pump devices. The pump's only moving part is a rotating impeller which 'floats' in the blood, reducing wear and potential for blood clots. The VentrAssist helps the heart to pump blood and does not require removal of the heart, providing the possibility for it to rest and recover. The pump is connected to an external controller and power source through a lead in the abdomen.
Designed and developed in Australia, the VentrAssist was first patented in 2001. The first human implant was made in June 2003 at The Alfred Hospital in Melbourne. By 2008, more than 250 implants had been made in 36 centres across ten countries. At this time the product had achieved CE Mark approval to market in Europe, TGA market approval in Australia, and was undergoing FDA trials in the USA....read more
The VentrAssist was developed by the Faculty of Engineering at University of Technology, Sydney and MicroMedical Industries (later known as Ventracor) over the period 1997-1999. A large team of biomedical experts developed the device based on an original invention by John Woodard (MicroMedical), Peter Watterson (UTS) and Geoffrey Tansley (UTS/MicroMedical). Initial funding for the VentrAssist was received from AusIndustry as an R&D Start Grant. Animal trials were undertaken from 2000 to 2002, and the first human implant was made in June 2003 at The Alfred Hospital in Melbourne. Extensive clinical trials were undertaken, initially in Australia and later in Europe and the USA. Market approval was received in Europe in 2006 and Australia in 2007, and trials continued in the US in 2008.
C-Pulse Heart Assist System by Sunshine Heart
The C-Pulse Heart assist system
is designed to treat clinical symptoms associated with Class III and ambulatory Class IV heart failure. These symptoms normally include shortness of breath, dizziness, low blood pressure and fluid retention. Patients associated with Class III and ambulatory Class IV heart failure are typically unable to engage in normal activities, compromising their quality of life. The C-Pulse Heart Assist System may be implanted through a minimally invasive or full sternotomy technique.
C-Pulse® has the potential to revolutionize the treatment of Class III and ambulatory Class IV heart failure. It uses counterpulsation technology to increase cardiac output, coronary artery blood flow and reduce the heart’s pumping workload.
• C-Pulse® is a therapeutic approach to treating heart failure and is currently an investigational device undergoing clinical evaluation.
The C-Pulse Cuff is placed around the ascending aorta, above the aortic valve. Image from Sunshine Heart.
The C-Pulse System’s design is based on proven balloon counter-pulsation technology to assist the heart by reducing the workload of the left ventricle. During inflation of the balloon, blood flow is increased to the coronary arteries, thereby providing additional oxygen which is vital to a failing heart. During deflation, the workload or pumping required by the left heart is reduced. The balloon inflation and deflation is synchronized to the patient’s ECG, similar to a pacemaker. Potential benefits of the technology, which are currently being analyzed in clinical trials, are relief of shortness of breath, increased physical activity, and improved cardiac function.
The C-Pulse is designed to improve heart function in three ways:
• More blood flow from the heart called increased cardiac output • More oxygen to the heart muscle, called increased coronary blood flow • Less work for the heart, called decreased afterload
Image from Sunshine Heart
The C-Pulse System may be implanted via a small pacemaker like incision through the ribs (mini-thoracotomy) and sternum (mini-sternotomy) or through a traditional full sternotomy. The anticipated stay in the hospital may be between 4-14 days. Several patients currently enrolled in the Company’s FDA approved IDE feasibility trial have been able to return home in as little as four days when the procedure has been performed minimally invasively.
The implant part of the procedure is typically performed in an hour. The cuff portion of the C-Pulse Device is placed around the ascending aorta, and outside the patient’s bloodstream. Because of this, the risk of stroke and blood clots is potentially reduced. There is also no need for patients to take anti-clotting medications such as heparin or warfarin while implanted unless other medical conditions require this. Because of these features, the procedural and device patient risks may be lower when compared to other currently approved Class III/IV mechanical circulatory assist technologies.
The C-Pulse can be temporarily disconnected. Patients have expressed satisfaction in being able to shower, take a walk and perform other activities independent from the system.
For more information and Patient Brochure Click here
Sunshine Heart focuses on an innovative cardiac assist therapy to treat heart patients who represent a large and under-served market segment and provide a significant opportunity for the company. Unfortunately, these Class IV patients, despite optimal drug therapy, have persistent symptomsand their options are very limited. Surgical approaches usually involve complex open-heart surgery or heart transplantation....read more
The BiVACOR® System
The BiVACOR™ is a device designed to support or totally replace a failing heart.
BiVACOR® is a major advance upon earlier generation artificial heart technologies which push blood from one side of the heart only. BiVACOR® can support both sides of a failing heart (BV Assist) or may act as a total artificial heart replacing the heart completely (BV Replace).
The core technology for this unique pump relates to the inclusion of left and right impeller vanes positioned on a common rotating disc. The device uses MAGLEV technology to completely suspend and rotate this disc, which affords it the unique ability to respond to a patient’s changing needs by dynamically altering its impeller position, to safely pump blood from both sides of the heart.
BiVACOR BV Assist – Designed to support the failing left and right heart
The key success factors for an implantable biventricular device are that it is small; reliable; and has a balanced blood flow.
No device until now has met all these criteria.
The notable design advantages of the BiVACOR® device that will account for its success are that it:
BiVACOR BV Replace – Designed to replace the ventricles of a totally failing heart
1. Is a single rotary pump that can assist or totally replace both sides of the heart;
2. Can be used for a bridge to recovery, bridge to transplant, or destination therapy;
3. It is small enough to implant in an 8 year old child, but powerful enough to support an adult;
4. Can simultaneously pump more than 8 l/min from both the left and right sides;
5. Only has one moving part (the central impeller), which is totally suspended inside large clearances using MAGLEV technology;
6. Has no contacting or rubbing components, so there is no wear, making it both reliable and durable (estimated potential life span of more than 10 years);
7. Automatically controls and balances blood flow in both cavities, with the movable impeller;
8. Can be powered across the skin with TET technology, maximising patient mobility and reducing infection;
9. Will be available ‘off the shelf’ so there is no wait for a compatible donor heart;
10. Can provide patients ineligible for transplant a treatment option.
BiVACOR® is a privately held company that was founded in 2008 and is based at The Prince Charles Hospital, Brisbane, Australia. A contingent of 6 highly qualified staff has worked diligently toward the development of this ground breaking technology. They include highly experienced and world class biomedical engineers, medical specialists and business executives, as well as support staff. Together they have set up a strong collaborative network which branches out both nationally and internationally. In addition, BiVACOR has engaged assistance from best of breed legal, financial and intellectual property specialists.
The BiVACOR® Total Artificial Heart featured in the 60 Minutes story “The Ultimate Bypass”, aired on September 24, 2010. The Ultimate Bypass
SmartHeartT Left Ventricular Assist Device and the SmartHeartT Total Artificial Heart by Cleveland Heart Inc.
The SmartHeartT LVAD.
The SmartHeartT LVAD
is comprised of an implanted centrifugal blood pump which is placed in the patient's chest below the heart. The pump takes blood from the patient's left ventricle via a titanium inlet cannula and returns it to the ascending aorta via a coated Dacron graft. The implanted pump is fabricated from titanium with a biocompatible coating applied to a portion of the blood-contacting surfaces. A power cable extends from the implanted pump through the skin to an external controller which powers the pump and regulates pump speed.
The SmartHeartT LVAD's elegant, simple design is intended to provide long term reliability and minimize complications. The pump's rotor, it's single moving part, turns on a hemodynamic bearing, a thin film of blood which supports and stabilizes the spinning rotor, obviating the need for mechanical bearings or other wear elements. This feature combined with the optimized blood flow path allows for minimal on-going anticoagulation. Since this design does not require active magnetic stabilization, the percutaneous power cable is small and flexible, minimizing exit site infections. The pump's small profile and integrated inlet cannula provide for intra-thoracic placement even in patients of small stature, reducing placement time and minimizing surgical complications.....read more
SmartHeartT Total Artificial Heart:
The SmartHeartT TAH is designed to replace the function of the native heart, supporting both systemic and pulmonary circulation. It is based on the design of the SmartHeartT LVAD, in which a single moving part the rotor, is supported in a blood-lubricated fluid film bearing, resulting in a small, simple, reliable device.
A single motor drives two centrifugal pumps on both ends of the same shaft. An integrated pressure regulating valve automatically balances left and right circulations without the need for a second motor, sensors and associated cables, connectors, electronics and software.
Unlike earlier generations of total artificial hearts, the SmartHeartT TAH's compact size allows for a broader range of patients to be implanted.
The TAH shares basic design concepts with the SmartHeartT LVAD: Find out
The SmartHeartT TAH
About Cleveland Heart Inc.
Cleveland Heart, Inc. has partnered with the Cleveland Clinic to develop the next generation of mechanical cardiac circulatory assist devices with the potential to provide a complete range of treatment options for patients suffering from irreversible end-stage heart failure.
• Boston Scientific: Mission: to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less invasive medical devices and procedures.
• St. Jude Medical The St. Jude Medical product portfolio includes implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, pacemakers, electrophysiology catheters, mapping and visualization systems, vascular closure devices, heart valve replacement and repair products.....
• Edwards Lifesciences Edwards is the leader in the development of new, experimental technologies designed for the non-surgical repair or replacement of heart valves. These transcatheter heart valve technologies would allow clinicians to repair or replace heart valves through a catheter, eliminating the need for open-heart surgery....
• Sorin Group A pioneer and leader in heart valve innovation for more than 40 years, Sorin Group, formerly known as ELA Medical, offers the most complete portfolio of bioprosthetic valves, mechanical valves, and repair products....
• Zoll Medical ZOLL defibrillators and AEDs are available in many models and with hundreds of customizable features, functions and languages to address the unique needs or organizations and clinicians everywhere....
Automated External Defibrillators (AEDs): Portable and automatic, these devices help restore normal heart rhythm to patients in cardiac arrest. They analyze heart rhythm and can help rescuers determine whether a shock is needed to restore a normal heartbeat.
Cardiac Ablation Catheters: Long, thin flexible tubes that are threaded into or onto the heart, cardiac ablation catheters treat abnormally rapid heartbeats that cannot be controlled with lifestyle changes or medications. They work by modifying small areas of heart tissue that are causing abnormal heart rhythms.
Cardiac Angioplasty Devices: These are long, thin, flexible tubes that are threaded into a heart blood vessel to open narrowed or blocked areas. They improve blood flow to the heart, reduce chest pain, and treat heart attacks.
Cardiac Pacemakers: Small and battery-powered, pacemakers are implanted permanently into the body. Used when the heart beats too slowly or has other abnormal rhythms, they monitor the organ's electrical impulses and, when needed, deliver electrical stimuli to make it contract in a more normal tempo.
Implantable Cardioverter Defibrillators (ICDs): These monitor heart rhythms and deliver shocks if dangerous rhythms are detected. Many record the heart's electrical patterns whenever an abnormal heartbeat occurs, allowing doctors to review the patterns. New monitoring devices allow ICDs to transmit basic information to physicians.
Prosthetic (Artificial) Heart Valves: Used for replacing diseased or dysfunctional heart valves, these are available in two forms. Mechanical valves are made of man-made materials and can usually last a lifetime. Biological valves are made from tissue taken from animals or human cadavers.
Stents: Small, lattice-shaped, metal tubes that are inserted permanently into an artery, stents help improve blood flow. Some contain drugs that reduce the chance that arteries will become blocked again.
Lindbergh and Carrel on the cover of Time magazine with The Lindbergh organ perfusion pump
Charles Lindbergh’s Artificial Heart
Just a few years after his historic solo flight across the Atlantic, the aviator developed an ingenious predecessor to today’s man-made hearts.
On a shelf in a largely ignored basement display case at Rockefeller University sit a variety of medical devices that have been produced by that institution’s laboratories over the past half century. One of them is especially awkward looking —a glass cylinder that rises two feet before sprouting a seemingly haphazard array of tubes. Its glass innards of more tubes and smaller chambers suggest the workings of some unidentifiable life-form.
It was alive once, in a manner of speaking. It is the world’s first artificial heart, unveiled fifty years ago with the publication of an article in Science magazine by its inventor, Charles A. Lindbergh, the man who became an instant hero in 1927 with his flight across the Atlantic. Descendants of the Lindbergh heart—in spirit if not direct lineage—have kept alive a handful of patients with diseased hearts in recent months.
The heart worked in connection with a sophisticated rotating valve, a thick disk enclosed in glass, with a tunnel bored through its diameter and two concavities of different sizes carved out of its circumference. The valve rotated in precise imitation of the systolic and the diastolic pressure that the beating of a natural heart exerts on arteries.
One of Charles Lindbergh's glass perfusion pumps
“That valve was an incredible piece of ingenuity,” reflects Merrill Chase, professor emeritus at Rockefeller University. Chase is the only living witness to Lindbergh’s four-year struggle to perfect the heart for the brilliant and controversial French surgeon Alexis Carrel, who was a staff member of what was then called the Rockefeller Institute for Medical Research. “The pump was a beautiful machine, but this was its key. Without the alternating pressure Carrel just couldn’t have studied organs with any degree of meaning.”
Lindbergh’s heart was never meant to be placed in a body; rather it was designed to keep organs alive for an indefinite period outside the body, and Lindbergh referred to it as a perfusion pump. The New York Times called it an artificial heart, and the name stuck. Time magazine described it as “a twist of vitrified bowel oozing out of a clear glass bottle.” Far bulkier than the Jarvik 7 in use today, it looked in profile like an abstract sculptor’s interpretation of a heron....read more
Haskell Shanks of Warren leaves Sinai Hospital in Detroit, becoming the first patient sent home with a partial artificial heart, on Sept. 18, 1971. / Sinai Hospital of Detroit
Michigan history: Heart booster gets ticking in Detroit Posted: August 7, 2011
Forty years ago this week, medical history was made in Detroit.
On Aug. 11, 1971, a permanent, partial artificial heart was implanted in Haskell Shanks, a 63-year-old former security guard from Warren, in an operation at Sinai Hospital in Detroit. Shanks became the first person in the world to have an artificial heart implanted and go home to live a normal life.
Shanks suffered from congestive heart failure and had suffered three heart attacks in the four years before the surgery. The six-inch, rubber-and-Dacron pump affixed to his aorta was called a patch booster and designed to do half the work of his own heart.
Leading the eight-man surgical team during a 10-hour operation that cost $25,000 was the famed Dr. Adrian Kantrowitz, who had completed the first human heart transplant in the U.S. four years earlier in New York.
At the time, doctors envisioned a day when permanent artificial hearts would come with their own power sources, such as radioactive isotopes or "biological fuel cells extracting sugar from the body."
Shanks was released from the hospital five weeks after the operation. He was readmitted Oct. 4 with a chest infection and died Nov. 11 of kidney failure.
Kantrowitz, who moved a 25-member team from New York to Detroit when he joined Sinai in 1970, remained in Michigan for the rest of his career. He taught at the Wayne State University School of Medicine and died in 2008 in Ann Arbor.
A little humor from the Scientists at Leads University
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