St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that physicians from the Cedars-Sinai Heart Institute will lead the company's transcatheter aortic valve implantation (TAVI) clinical trial. The study will evaluate the safety and efficacy of the St. Jude Medical transcatheter aortic valve for patients who experience severe aortic stenosis and who may be at an elevated risk for open-heart surgery.
"St. Jude Medical is pleased to have world-renowned physicians directing the clinical research for our TAVI program," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. "Dr. Gregory Fontana and Dr. Raj Makkar have been extensively involved in previous research efforts pertaining to transcatheter aortic valve implantation and are leading authorities for these technologies. We believe this is an important milestone for our program."
Raj Makkar, M.D., director of interventional cardiology and associate director of the Cedars-Sinai Heart Institute in Los Angeles, has extensive experience in high-risk percutaneous coronary and valvular interventions and the use of advanced percutaneous circulatory support devices. Under Dr. Makkar's direction, Cedars-Sinai physicians completed the most aortic valve replacements in an international clinical trial at more than 20 medical centers. He is a principal investigator for several research protocols involving transcatheter interventions and devices.
Gregory Fontana, M.D., is a cardiac surgeon at the Cedars-Sinai Heart Institute and has been a principal investigator for several research protocols involving transcatheter interventions and minimally invasive surgical devices. As a widely published researcher and author, Dr. Fontana's writings include more than 80 academic works appearing as articles, book chapters, abstracts and reviews. Published subject matter includes treatments for diseases of the coronary arteries, heart valves, heart transplantation and congenital heart defects.
Dr. Fontana presented a paper, "Progress with the St. Jude Medical TAVI System," at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in the Walter E. Washington Convention Center in Washington, D.C.
The St. Jude Medical transcatheter heart valve, made of pericardial tissue, is designed to increase physicians' control and accuracy during valve deployment. Two delivery methods for the St. Jude Medical transcatheter valve will be evaluated in the trial, the transfemoral and the transapical systems, which are both designed to make transcatheter valve deployment and retrieval easier for clinicians.
The European clinical trial of the St. Jude Medical transcatheter aortic valve is expected to start in 2011.