cms decision in us , page-7

Sep 15th is correct but with commercialisation at least 2 years away there is no hurry.



Thoratec Comments on Timing of LVAD Destination Therapy Coverage Decision By CMS


PLEASANTON, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, today commented on an update issued by the Centers for Medicare & Medicaid Services (CMS) that it will not be issuing its National Coverage Decision regarding coverage for LVADs (left ventricular assist devices) for Destination Therapy by its latest deadline of August 13. In its update, CMS indicated it expects to issue its decision by September 15, 2003.

"This latest delay is very disappointing, particularly for the many very sick end-stage heart failure patients who can benefit from this procedure," said D. Keith Grossman, president and chief executive officer of Thoratec.

"From our perspective, nothing in our discussions with CMS has changed our view that they will issue a positive National Coverage Decision for this indication, given the overwhelming evidence of patient benefit demonstrated by the REMATCH clinical trial and the support of leading clinicians throughout the country. We will continue to support CMS in their deliberations in any way possible and trust they are mindful that they requested an early filing on this request for coverage more than a year ago, followed by a strong recommendation for coverage by the MCAC (Medicare Coverage Advisory Committee) panel more than five months ago," he added.

"This delay in the reimbursement decision process is a real blow to patients," noted Karl Nelson, clinical director of VAD programs at LDS Hospital in Salt Lake City, and chairman of the Hospital Alliance for VADs. "Because reimbursement is not in place, we have already had to turn away Medicare patients who were in desperate need of a device implant. It is not fair that these patients are denied access to the same level of life-saving treatment that is available to those with private insurance," he continued.

Thoratec Corporation is a world leader in products to treat 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.

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, 2003, and other filings 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