Thoratec, engaged in device-based mechanical circulatory support therapies for failing hearts, has received FDA approval for its PMA supplement, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) for Destination Therapy (DT).
The company claims that with this approval, the HeartMate II can be used to provide long-term cardiac support for patients suffering from advanced-stage heart failure who are not eligible for transplantation.
Thoratec is expected to begin the rollout of the device for the DT indication immediately and has sufficient inventory to address the expected increase in demand. The device was approved for Bridge-to-Transplantation (BTT) in the US, under the original Pre-Market Approval (PMA) in April 2008.
The approval allows the HeartMate II to be used in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation.
As a condition of approval, the company has agreed to a post-approval study of 247 patients who will be followed until outcome or two years, whichever occurs first. The company will utilize the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to collect the FDA-required data on outcomes, adverse events, functional status and quality of life.
The company has also agreed to conduct a second small study at three specific centers to collect data regarding the relationship between bleeding, thrombosis, von Willebrand syndrome and anticoagulation in LVAD (Left Ventricular Assist Device) patients.
The HeartMate II and the HeartMate XVE are the only devices approved by the FDA for both DT and BTT. A continuous flow device, the HeartMate II is an implantable LVAS powered by a rotary pumping mechanism. It is designed to have a much longer functional life than pulsatile devices and to operate more simply and quietly.
The device provides blood flow through the circulatory system on a continuous basis with only one moving part. It is also smaller and easier to implant than previously approved pulsatile devices.