SynCardia Announces Destination Therapy Implants of Its Total Artificial Heart in Europe.TUCSON, Ariz. -- Physician-initiated Use of the CardioWest(TM) Temporary Total Artificial Heart in End-Stage Heart Failure End-stage heart failure Severe heart disease that does not respond adequately to medical or surgical treatment. Mentioned in: Heart Transplantation Patients with No Option for Transplantation SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and mechanical circulatory support devices, announced today use of its CardioWest(TM) Temporary Total Artificial Heart (TAH-t) as a permanent cardiac replacement--also called destination therapy--in two patients in Europe. Over the past few weeks, the Heart Center NRW NRW Nordrhein-Westfalen (German Federal State; Capital Düsseldorf) NRW Non-Revenue Water NRW Northern Right Whale NRW Nicolson-Ross-Weir (measurement technique) NRW Nonradioactive Waste at Bad Oeyenhausen, Germany, under the leadership of Drs. El Banyosy and Reiner Korfer, and the German Heart Institute in Berlin, under the leadership of Drs. Michael Jurmann and Roland Hetzer, have successfully implanted the devices. The decisions to use the CardioWest(TM) TAH-t were physician-initiated, not sponsored by SynCardia, and met individual medical center ethics committee ethics committee A multidisciplinary hospital body composed of a broad spectrum of personnel–eg, physicians, nurses, social workers, priests, and others, which addresses the moral and ethical issues within the hospital. See DNR, Institutional review board. approval. The CardioWest(TM) TAH-t was chosen for these patients as they had irreversible bi-ventricular heart failure and were ineligible for transplants. Both patients have successfully recovered on the CardioWest(TM) TAH-t and have been discharged home on portable drivers adapted to power the TAH TAH abbr. total abdominal hysterectomy TAH 1 Total abdominal hysterectomy 2 Transfusion-associated hepatitis, see there . "We are encouraged by this physician-initiated effort into the domain of destination therapy," said Dr. Marvin J. Slepian, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , SynCardia Systems. "While currently approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. as a bridge-to-transplantation device, the CardioWest(TM) TAH-t has, by engineering design, the intrinsic potential to serve as a long-term cardiac replacement. In the future we hope to launch a formal company-sponsored destination therapy trial, with the approval of regulatory agencies, both outside of and within the United States." The CardioWest(TM) TAH-t is the first FDA-approved temporary total artificial heart. It is currently indicated for use as a bridge-to-transplant in cardiac transplant-eligible candidates at risk of imminent death from non-reversible bi-ventricular failure. The device is being used in heart transplant centers in the United States and Europe. Additional clinical studies are also being conducted with new, smaller drivers from MEDOS AG and Berlin Heart AG. About the CardioWest(TM) Temporary Total Artificial Heart The CardioWest(TM) TAH-t is a pneumatic, biventricular, implantable bridge-to-transplant system for full cardiac replacement, taking the place of the failing heart in patients at imminent risk of death. The device offers full circulatory support, the shortest blood path and exposure to artificial surfaces, and the highest level of cardiac output cardiac output n. Abbr. CO The volume of blood pumped from the right or left ventricle in one minute. It is equal to the stroke volume multiplied by the heart rate. when compared with other artificial heart systems previously tested. With the CardioWest(TM) TAH-t, patients become better candidates for eventual transplantation and have post-transplant survival rates equal to that of non-device cardiac recipients. About SynCardia Systems Founded in 2001, SynCardia Systems is the developer of biomechanical cardiac replacement and assist devices. Its CardioWest(TM) Temporary Total Artificial Heart (TAH-t) is designed for severely ill patients with end-stage congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. . The device serves as an in-hospital bridge-to-transplantation for patients at imminent risk of death. SynCardia Systems is based in Tucson, Arizona and is on the Web at http://www.syncardia.com. |
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