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Robert Kormos

UPMC Media Relations

University of Pittsburgh Medical Center Among First to Receive Medicare Approval to Implant Heart Assist Device as "Destination Therapy"

PITTSBURGH, November 3, 2003 The University of Pittsburgh Medical Center (UPMC) is among the first centers to receive approval from the Centers for Medicare & Medicaid Services (CMS) to implant left ventricular assist systems (LVAS) approved by the U.S. Food and Drug Administration (FDA) as destination therapy for heart failure patients who do not qualify for transplantation. Currently, the only FDA-approved device for destination therapy, or permanent support, is Thoratec Corporation's HeartMate XVE LVAS.

Assist devices are used most often as a bridge to transplantation. In some cases, the devices allow the heart to heal and heart transplantation is avoided. Until FDA and CMS granted approval of the HeartMate system, patients not considered candidates for transplantation did not have the option of being supported with current devices.

"This new technology will afford a number of patients with better quality of life and provide them with renewed time with family and loved ones. We are pleased to be able to offer this treatment, which marks a new era for the use of ventricular assist devices," stated Robert L. Kormos, M.D., professor of surgery at the University of Pittsburgh School of Medicine and director of UPMC's Artificial Heart and Cardiothoracic Transplant programs.

"For more than 15 years, our Artificial Heart Program, in conjunction with UPMC's Congestive Heart Failure Program, has been a key player in the evolving use of mechanical support. We have always kept in focus the ultimate use of these devices as replacement or destination therapy for those who do not qualify for heart transplantation," he added.

In order to qualify for Medicare approval, centers must have performed at least 15 bridge-to-transplant or destination-therapy ventricular assist device (VAD) implants through the National Institutes of Health- and Thoratec-sponsored Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial. Volume is based on implants performed since Jan. 1, 2001, with devices approved for either commercial or investigational use.

Destination therapy is for patients who require permanent mechanical heart support. Specifically, Medicare approval covers those patients with chronic end-stage heart failure who have a life expectancy of less than two years and who do not qualify for transplantation. Patients must meet additional medical criteria.

The list of Medicare-approved facilities is available at http://www.cms.hhs.gov/coverage/lvadfacility.asp. UPMC is the only approved center in western Pennsylvania and the only center to serve patients in eastern Ohio and West Virginia.

UPMC's Artificial Heart Program is one of the most experienced and active in the United States. Since its inception in 1985, the program has supported nearly 250 patients on assist devices for a period of time that equates to more than 50 years. It often serves as both a proving ground for manufacturers and a training center for surgeons from around the world. Devices that UPMC has used over the years include the Jarvik/Cardiowest Total Artificial Heart, Novacor Left Ventricular Assist Device (LVAD), Thoratec VAD and HeartMate I.

Known also for its aggressive work to enable patients on devices to be discharged to the home setting, UPMC was the first center to discharge a patient still on a device to await a human donor outside the hospital. Based on UPMC's experience, the FDA later allowed patients implanted with the Novacor to be discharged to their home to await heart transplant.

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