Thoratec Reports 14 Percent Growth in Cardiovascular Division Sales as Third Quarter Revenues Increase Ni... (rollment in our U.S. trial for Destinati...)

Thoratec Reports 14 Percent Growth in Cardiovascular Division Sales as Third Quarter Revenues Increase Nine Percent

Date:11/4/2009

rollment in our U.S. trial for Destination Therapy (DT) under Continued Access Protocols (CAPs). This growth occurred despite facing a difficult comparable due to the commercial launch of the HeartMate II for BTT last year," said Gary F. Burbach, president and chief executive officer of Thoratec. "Our Cardiovascular Division activity was offset by a modest decline in revenues at our International Technidyne Corporation (ITC) Division year-over-year," he added.

Burbach said the company believes it remains on track to have Destination Therapy approval for the HeartMate II by early 2010. "We were recently informed by the FDA that they will not utilize a panel as part of their review process. We believe we have successfully responded to all of the FDA's engineering and clinical questions and have been working with them on the specifics of the post-approval study and device labeling. We are looking forward to the presentation of the DT trial data as a late-breaking clinical trial at the 2009 Scientific Sessions of the American Heart Association meeting in two weeks," Burbach noted. "In the meantime, there have been a number of recent presentations and publications of updated data from the HeartMate II BTT trial and commercial experience that continue to demonstrate positive patient outcomes."

The company said it added five new HeartMate II centers in North America during the quarter, bringing the total added this year to 14 and an overall total of 115 in North America. The company said it also added seven new HeartMate II centers outside of North America during the quarter, bringing the total added this year to 12 and the overall total internationally to 89.

Thoratec also said it had completed a successful launch of the new HeartMate external peripherals, including new batteries, charger and power module. Patient and clinician feedback on these enhanced offerings, which provide patients more freedom and mobility, has been highly positive
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Thoratec Reports 14 Percent Growth in Cardiovascular Division Sales as Third Quarter Revenues Increase Ni...(rollment in our U.S. trial for Destinati...),Health