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Devices Cardiology Personnel

 News Release - March 20, 2007

Renowned Biomedical Scientists Come to Tucson to Review the World's First and Only temporary Total Artificial Heart

TUCSON, Ariz.--(HSMN NewsFeed)--SynCardia Systems, Inc., manufacturer of the world's first and only FDA and CE Mark approved temporary Total Artificial Heart, is looking to the future so this lifesaving technology can be used to save more patients. To reach this goal the company has researched and recruited five of the world's leading biomedical scientists and physicians to review the CardioWest(TM) temporary Total Artificial Heart (TAH-t). The Science Advisory Board (SAB) met on March 15th and 16th in Tucson, Arizona.

"The Science Advisory Board represents the best minds in biomedical science and technology today. The TAH-t is in a class by itself. It is proven and reliable ... the SAB will help keep the TAH-t state-of-the-art," explained SynCardia's Chairman Dr. Marvin Slepian.

Originally designed as a permanent replacement heart, known then as the Jarvik 7, the modern version of this heart, the CardioWest(TM) TAH-t has been studied and in use for close to 20 years. The current FDA and CE Mark indication (approved use) is as a bridge to transplant. The TAH-t has been implanted in over 650 patients accounting for more than 100 patient years on this device.

Recruited by SynCardia Co-Founder and Chairman Dr. Marvin Slepian, members of the SAB include Dr. Art Coury, Dr. Syed Hossainy, Dr. Frederick Schoen, Prof. Shmuel Einav and Dr. Daniel Burkhoff. Each member brings extensive industry experience with biomaterials and implantable medical devices.

This was the group's first visit to the TAH-t manufacturing facility, a Controlled Environmental Suite located in Tucson, Arizona. The SAB reviewed manufacturing processes, materials and existing practices.

About Science Advisory Board members:

Dr. Art Coury serves as President, Biomaterials Research at Genzyme Corporation. His career focus has been polymeric biomaterials for implantable devices, having recently given a talk on the stability of polymers for permanent implants. This year, he was recognized with the 2007 Innovation and Technology Development Award from the Society for Biomaterials.

Dr. Fred Schoen is a Professor of Pathology and Health Sciences and Technology, Harvard Medical School. Dr. Schoen's areas of interest include cardiovascular pathology, cardiovascular biomaterials, prosthetic heart valve pathology, and tissue engineering. His research has included structure-function-pathology correlations in heart valve substitutes and other cardiovascular prostheses, cardiovascular tissue engineering, and heart transplantation.

Dr. Daniel Burkhoff is Medical Director of IMPULSE Dynamics, a startup company investigating a device-based therapy for chronic heart failure. He is the author of many original articles, invited reviews, and book chapters on cardiology, and serves as a reviewer for multiple cardiology journals. His research interests include basic and clinical work in ventricular mechanics, cardiovascular physiology, coronary circulation, heart failure, and left ventricular assist devices.

Prof. Shmuel Einav is a world-distinguished expert in the cardiovascular circulatory system and the field of biomedical engineering. He has published 84 scientific articles, five invited chapters and a multitude of abstracts in the biomedical engineering, fluid mechanics and medical fields. He lectures extensively around the world and frequently speaks at international conferences.

Dr. Syed Hossainy is a Research Fellow and Director at Guidant Vascular Intervention who has published numerous papers in the field of biomedical materials research. He has been awarded numerous patents including a patent for coating for implantable devices and a method of forming the coating.

About the CardioWest TAH-t:

The CardioWest(TM) TAH-t is a modern version of the Jarvik-7 Artificial Heart that was first implanted in Barney Clark in 1982. In the 1990s the device and technology were moved to University Medical Center in Tucson and subsequently renamed the CardioWest(TM) temporary Total Artificial Heart. SynCardia was formed in 2001 by Marvin J. Slepian, M.D., Richard G. Smith, MSEE, CCE, and surgeon Jack Copeland, M.D.

A New England Journal of Medicine paper published on August 26, 2004 (NEJM 2004; 351: 859-867) states that in the pivotal clinical study of the TAH-t, the one-year survival rate for patients receiving the CardioWest TAH-t was 70 percent versus 31 percent for control patients who did not receive the device. One-year and five-year survival rate survival rates after transplantation among patients who had received a TAH-t as a bridge to human heart transplant were 86 and 64 percent.

Source: SynCardia Systems

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