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thoratec comment of medicare delays

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    PLEASANTON, Calif., Sep 16, 2003 /PRNewswire-FirstCall via COMTEX/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, today commented on the elapsed date for the issuance of a National Coverage Decision for LVADs (left ventricular assist devices) for Destination Therapy by the Centers for Medicare & Medicaid Services (CMS).

    "CMS provided no update on yesterday's due date for this coverage decision. However, we continue to have an ongoing positive dialog with them and we are encouraged by our belief that part of the delay may be a result of ongoing deliberations at CMS regarding different potential reimbursement scenarios that might be more equitable and appropriate for the providers of this therapy," said D. Keith Grossman, president and chief executive officer of Thoratec.

    "As we have stated in the past, the evidence of patient benefit is overwhelming as demonstrated by the REMATCH clinical trial -- a finding further supported by a strong recommendation for coverage by CMS's MCAC (Medicare Coverage Advisory Committee) panel which occurred more than six months ago. We understand the magnitude of the decision and appreciate the importance of CMS' deliberations. At the same time, there are real patients and their families waiting for access to this life-saving therapy and we hope CMS will implement a National Coverage Decision very quickly, as well as appropriate levels of reimbursement and an effective date as soon as possible," Grossman added.

    Thoratec Corporation is a world leader in products to great cardiovascular disease with its HeartMate(R) LVAS (left ventricular assist systems) and Thoratec(R) VAD (Ventricular Assist Device) implanted in more than 6,000 patients suffering from heart failure. In November 2002, the HeartMate was approved by the FDA as the first, and to date only, heart assist device for Destination Therapy, or permanent support, providing a new lifesaving treatment for end-stage heart failure patients ineligible for cardiac transplantation
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