The FDA has approved Thoratec Corporation’s PMA for the HeartMate II Left Ventricular Assist System (LVAS). PMA’s are hard to get cleared and implantable blood pumping devices are notoriously difficult to successfully engineer, so you can bet the folks in Pleasanton, CA are in high spirits these days. Some highlights from the press release…
The approval follows a successful clinical trial involving more than 450 BTT patients, including those enrolled under Continued Access Protocols, and a unanimous recommendation for approval from the FDA Circulatory System Devices Advisory Panel last November.
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.
"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.
More from Thoratec…
Product page: HeartMate II Left Ventricular Assist System…
UPDATE: Statement from the FDA: FDA Approves First Compact Heart Assist Device…
Flashbacks: HeartMate® II Left Ventricular Assist System; Canadian Receives HeartMate II Non-Pulsatile LVAD, Eh?; HeartMate II Shown Effective In Waiting Transplant Candidates