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| Type | Private |
|---|---|
| Industry | Medical Devices |
| Founded | August 2013 in Houston, Texas, United States |
| Headquarters | |
Key people |
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| Website | reliantheart |
ReliantHeart, Inc. is a privately held American company headquartered in Houston, Texas that designs, manufactures, and provides remote monitoring capabilities for its left ventricular assist devices (LVAD, or VAD) which are used to assist circulation for failing hearts.
The original VAD was developed by David Saucier, a heart transplant patient who worked at NASA, and surgeon Michael DeBakey. [1] [2] Dallas W. Anderson, who founded MicroMed Technology Inc. in 1995, [3] was granted exclusive rights to the NASA/DeBakey VAD in 1996. [4] MicroMed Cardiovascular, Inc. filed for Chapter 11 bankruptcy in June 2013, [5] and former members of the company founded ReliantHeart Inc. in August 2013. [6] ReliantHeart became successor-in-interest to the assets of MicroMed Cardiovascular, Inc., including the HeartAssist5 VAD. [7] In August 2014, ReliantHeart purchased 50% of INRTracker, [8] an online tool for patients taking Warfarin and reporting of INR. [9]
The HeartAssist5 is a modern version of the DeBakey VAD [10] and as of December 2014 was the only remotely monitored medical device in the world. [8] It was first approved for use in Europe in 2009 under MicroMed Cardiovascular, Inc. [11] The HeartAssist5 is in use in Europe [10] as a destination therapy by patients who are not candidates to receive heart transplants and as a bridge to transplant for those who are. [12]
The HeartAssist5 is an axial flow pump and the smallest of the full-flow LVADs. Its pump is slightly larger in diameter than a U.S. quarter or one-Euro coin and weighs only 3.2 ounces (92 grams). [13] The small size allows for the device to be implanted adjacent to the heart and above the diaphragm; this is unique among LVADs. [14]
The aVAD is an intraventricular implant. It has the same blood path as the HeartAssist5 but also has active magnetic stabilization, [15] is smaller than the HeartAssist5, and operates with more efficiency and power. [16] The aVAD was approved for use in Europe in August 2016, and implantations were expected to begin as early as that September. [17]
CE Mark – The aVAD and the HeartAssist5 VAD are CE Mark-approved in Europe for use in patients requiring ventricular support due to end stage heart failure. [18] [19] [20]
IDE clinical trial – ReliantHeart Inc. was granted approval from the FDA to conduct an Investigational Device Exemption (IDE) Clinical Trial on the HeartAssist5® Ventricular Assist Device System for patients awaiting cardiac transplant. [21] The study began in September 2014. The University of Chicago Medicine implanted the HeartAssist5 into the first patient in the United States in March 2015. [12]
True Flow Measurement The Flow Probe in the aVAD and HeartAssist5 is a tool to observe interaction between the device and the ventricle. This allows for clinicians to confirm that the aortic valve is opening as the ventricle is pressurized. The measurement is unaffected by changes in blood or fibrin deposition, which eliminates the need for estimation. [22]
Remote Monitoring is real time Machine to Machine (M2M) – devices communicating via data transmission and generating alerts based on the data transmitted. Through the HeartAssistRemote Monitoring System, patient data is relayed, using the Numerex Network, to a secured VADLink [23] website that can be accessed by the clinical team [24] and enables fast diagnosis regardless of patient location. [17]
The HeartAssistRemote Monitoring System received a 2014 M2M Telehealth Award from M2M Evolution Magazine. [23]
An artificial heart is a device that replaces the heart. Artificial hearts are typically used to bridge the time to heart transplantation, or to permanently replace the heart in the case that a heart transplant is impossible. Although other similar inventions preceded it from the late 1940s, the first artificial heart to be successfully implanted in a human was the Jarvik-7 in 1982, designed by a team including Willem Johan Kolff, William DeVries and Robert Jarvik.
AbioCor was a total artificial heart (TAH) developed by the Massachusetts-based company AbioMed. It was fully implantable within a patient, due to a combination of advances in miniaturization, biosensors, plastics and energy transfer. The AbioCor ran on a rechargeable source of power. The internal battery was charged by a transcutaneous energy transmission (TET) system, meaning that no wires or tubes penetrated the skin, reducing the risk of infection. However, because of its size, this heart was only compatible with men who had a large frame. It had a product life expectancy of 18 months.
A ventricular assist device (VAD) is an electromechanical device for assisting cardiac circulation, which is used either to partially or to completely replace the function of a failing heart. The function of a VAD differs from that of an artificial cardiac pacemaker in that a VAD pumps blood, whereas a pacemaker delivers electrical impulses to the heart muscle. Some VADs are for short-term use, typically for patients recovering from myocardial infarction and for patients recovering from cardiac surgery; some are for long-term use, typically for patients suffering from advanced heart failure.
Gerson "Gus" Rosenberg, Ph.D., is an American biomedical engineer. He is the Jane A. Fetter Professor of Surgery, professor of bioengineering, and chief of the Division of Applied Biomedical Engineering at Penn State's Milton S. Hershey Medical Center and Penn State College of Medicine.
Abiomed is a publicly-traded medical devices company that develops and manufactures external and implantable circulatory support devices. The company is headquartered in Danvers, Massachusetts and has three additional offices, two in Germany in the cities of Berlin and Aachen, and another in Tokyo, Japan. Michael R. Minogue is Chairman, CEO & President of the company, with Dr. Thorsten Siess as Chief Technology Officer, Dr. Chuck Simonton as Chief Medical Officer and Dr. David M. Weber as Chief Operating Officer. According to Bloomberg, the company "engages in the research, development, and sale of medical devices to assist or replace the pumping function of the failing heart. It also provides continuum of care to heart failure patients". As of 2019, the company had secured five FDA approvals and 715 patents with 622 pending. For fiscal year 2019, Abiomed reported $769.4 million in revenue and reported diluted earnings per share was $5.61 for the year.
O. H. "Bud" Frazier is a heart surgeon and director of cardiovascular surgery research at the Texas Heart Institute (THI), best known for his work in mechanical circulatory support (MCS) of failing hearts using left ventricular assist devices (LVAD) and total artificial hearts (TAH).
Adrian Kantrowitz was an American cardiac surgeon whose team performed the world's second heart transplant attempt at Maimonides Medical Center in Brooklyn, New York on December 6, 1967. The infant lived for only six hours. At a press conference afterwards, Kantrowitz emphasized that he considered the operation to have been a failure.
Peer Michael Portner was a heart researcher whose work led to the development of the ventricular assist device, an electrical pump that permits patients in heart failure to survive until a heart transplant could be performed.
Destination therapy is a therapy that is final rather than being a transitional stage until another therapy—thus, in transportation metaphor, a destination in itself rather than merely a bridge or road to the destination. The term usually refers to ventricular assist devices or mechanical circulatory support to keep the existing heart going, not just until a heart transplant can occur, but for the rest of the patient's life expectancy. It is thus a course of treatment for severe heart failure patients who are not likely candidates for transplant. In contrast, bridge-to-transplant therapy is a way to stay alive long enough, and stay healthy enough, to await transplant while maintaining eligibility for transplant.
Thoratec Corporation is a United States-based company that develops, manufactures, and markets proprietary medical devices used for mechanical circulatory support for the treatment of heart-failure patients worldwide. It is a global leader in mechanical circulatory support devices, particularly in ventricular assist devices (VADs).
Charles D Fraser, Jr. is the medical director and surgeon of the Texas Center for Pediatric and Congenital Heart Disease at Dell Children's Medical Center. Formerly, Fraser was chief of congenital heart surgery and cardiac surgeon-in-charge at Texas Children's Hospital, the nation's largest pediatric hospital, served as chief of the Congenital Heart Surgery Division at Baylor College of Medicine, and director of the Adult Congenital Heart Surgery Program at the Texas Heart Institute.
William F. Bernhard was an American cardiovascular surgeon, Emeritus Professor of Surgery at Harvard Medical School, and cardiovascular surgical pioneer.
James K. Kirklin is an American cardiac surgeon who has made significant scientific and surgical contributions in the fields of heart transplantation and mechanical circulatory support devices to assist the pumping action of the heart. He is Professor of Surgery, former Director of the Division of Cardiothoracic Surgery (2006-2016), Director of the James and John Kirklin Institute for Research in Surgical Outcomes (2016–present), former Co-Director of the University of Alabama at Birmingham (UAB) Comprehensive Cardiovascular Center and holds the James Kirklin Chair of Cardiovascular Surgery at UAB.
Sharon Ann Hunt is a cardiology professor and Director of the Post Heart Transplant Programme in Palo Alto, California and is affiliated with Stanford University Medical Center, professionally known for her work in the care of patients after heart transplantation.
Berlin Heart GmbH is a German company that develops, produces and markets ventricular assist devices (VADs). The devices mechanically support the hearts of patients with end-stage heart failure. Berlin Heart's products include the implantable INCOR VAD and the paracorporeal EXCOR VAD. To date, Berlin Heart produces the only device of its kind available for babies and children with severe heart failure.
Charles Parks Richardson is an American doctor, an inventor, and serial entrepreneur.
Pump thrombosis (PT) is considered a specific case of a major device malfunction, and is classified as either suspected or confirmed pump thrombus. Typically, the device is an implanted blood pump such as a Left ventricular assist device. The malfunction is a blockage in the flow of blood anywhere along a vessel and it is mainly due to the bio-incompatible presence of a fairly complex mechanical apparatus. Pump thrombus is dreaded complication of CF LVAD technology that can require repeat surgery to replace the pump or lead to death.
Bridge therapy is therapy intended, in transportation metaphor, to serve as a figurative bridge to another stage of therapy or health, carrying a patient past a challenging period of some kind. There are various types of bridge therapy, such as bridge to transplant, bridge to candidacy, bridge to decision, bridge to recovery, and anticoagulation bridge. Bridge therapy exists in contrast to destination therapy, which is the figurative destination rather than a bridge to something else.
Jack Greene Copeland is an American cardiothoracic surgeon, who has established procedures in heart transplantation including repeat heart transplantation, the implantation of total artificial hearts (TAH) to bridge the time to heart transplant, innovations in left ventricular assist devices (LVAD) and the technique of "piggybacking" a second heart in a person, while leaving them the original.
Eric A. Rose is an American cardiothoracic surgeon, scientist, entrepreneur and professor and Chairman of the Department of Population Health Science & Policy, and Associate Director for Clinical Outcomes at Mount Sinai Heart. He is best known for performing the first successful paediatric heart transplant, in 1984 while at NewYork–Presbyterian Hospital (NYP).