"Clearly, the highlight of the quarter was the unanimous recommendation by the FDA Circulatory System Devices Advisory Panel on November 30 that the agency approve, with conditions, our PMA (PreMarket Approval) allowing the use of our HeartMate II for Bridge to Transplant," Burbach noted.
"It was the panel's view that the trial data demonstrated the safety and efficacy of the device, and we believe that the conditions outlined in their recommendations will not limit our ability to increase adoption of the HeartMate II. We have been engaged in a productive process with the FDA since then, and by the end of the week we expect to have submitted all the information the FDA has requested with respect to labeling, the development of an appropriate post-approval study and updates to patient data, and believe we are on track for approval and launch at the end of this quarter," he continued.
As of January 25, 2008, enrollment in the Destination Therapy arm was 479 patients, an increase of 53 patients over the 426 patients three months ago. Enrollment in the randomized portion of the DT arm of the trial was 291 patients, versus 265 patients three months ago. Two year follow up on the pivotal 200 randomized Destination Therapy patients will be complete in May 2009. Enrollment in the BTT arm of the trial was 439 patients, compared with 390 patients as of October 26, 2007.
Total enrollment in the Pivotal trial as of January 25 was 918 patients versus 816 three months ago, and an increase of 415 patients over the 503 patients enrolled a year ago.
Thoratec reported revenues of $234.8 million in 2007 com
|SOURCE Thoratec Corporation|
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