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“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™
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. 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™ 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™ 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.
# # #
Media contact:
SynCardia Director of Communications
Donald Isaacs
Cell: 520-955-0660
About the CardioWest™ temporary Total Artificial
Heart
The CardioWest™ 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 when compared with other artificial heart systems previously
tested. With the CardioWest™ 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™ temporary Total Artificial Heart (TAH‑t)
is designed for severely ill patients with end-stage congestive heart failure.
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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