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thoratec comments on status of lvad

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    Thoratec Comments on Status of LVAD Destination Therapy Coverage
    Tuesday, September 16, 2003 12:02 PM ET

    PLEASANTON, Calif., Sept. 16 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR, news), 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® LVAS (left ventricular assist systems) and Thoratec® 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.


    The portions of this news release that relate to future plans, events or performance, are forward-looking statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to continuing analysis of the REMATCH trial data, regulatory approval processes and healthcare reimbursement and coverage policies. These factors, and others, are discussed more fully under the heading, "Risk Factors" in Thoratec's 10-K for the fiscal year ended December 28, 2002, and other flings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

    Source: Thoratec Corporation

    Contact: Investors, Wayne Boylston, Chief Financial Officer of Thoratec Corporation, +1-925-846-8600; or Media, April Grefthen, ext. 165, or [email protected], or Jakob Jakobsen, ext. 161, or [email protected], both of FischerHealth, Inc., +1-310-577-7870, for Thoratec Corporation

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