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
-- 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
|SOURCE Thoratec Corporation|
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