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Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Transplantation
Date:4/21/2008

e patients," he added.

The approval was based on one-year follow-up data from the first 194 HeartMate II BTT patients enrolled in the trial. Highlights of the data included in the final PMA submission included:

-- The median duration of support was 132 days, and the cumulative

patient support in the trial was 109 years.

-- Survival to cardiac transplantation, recovery or ongoing on HeartMate

II support was 80 percent at six months and 77 percent at one year.

-- Eighty four percent of the patients survived to hospital discharge or

transplantation.

-- Significant improvements were observed across all measures of

functional status and quality of life as compared to baseline status.

-- The incidence of major adverse events with comparable

definitions -- including infections, strokes and bleeding requiring

surgery -- was significantly lower than what was clinically observed

in the previous BTT study of the HeartMate VE LVAS.

The approval allows the HeartMate II to be used to treat small patients (BSA < 1.5) based on body habitus if the treating clinician believes that the patient could benefit from the device. In addition, Thoratec will conduct a post-market study that includes a concurrent comparator. The study will follow 169 HeartMate II patients until outcome, or one year -- whichever comes first -- and gather data regarding survival, adverse events, patient gender, small patients and anticoagulation levels.

"With this BTT approval, we will now initiate our sales and marketing programs designed to place the HeartMate II in transplant centers that did not participate in the clinical trial. Our hope is to add about 40 new centers during the balance of the year, which would bring the total number of centers implanting the HeartMate II to approximately 80 centers.

"The foundation of this effort is a strong training program and supp
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SOURCE Thoratec Corporation
Copyright©2008 PR Newswire.
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