PLEASANTON, Calif. /PRNewswire via COMTEX/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said Weds. that it has received FDA approval of its PMA (Pre-Market Approval) supplement, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) for Destination Therapy (DT).

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 said it will 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 U.S. under the original 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. The PMA approval was based on a filing submitted in April 2009 that included two-year data on a pivotal study cohort of 200 randomized patients enrolled at 38 centers. Patients in the HeartMate II DT trial were randomized to the HeartMate II or the HeartMate(R) XVE--the only other device approved for DT--on a 2:1 basis, respectively. Patients in the pivotal cohort ranged in age from 26-81 years old, with a median age of 64 years. Also included in the primary analysis were data on 24 small BSA (body surface area) patients who because of their body size could not be randomized to the larger HeartMate XVE. The filing also included data on adjunctive cohorts totaling an additional 409 patients, including those who had been originally supported by a HeartMate XVE, and based on the need for device replacement, elected to receive a HeartMate II, as well as patients enrolled under Continuous Access Protocols (CAPs).
"This is truly a momentous day for the hundreds of thousands of underserved advanced-stage heart failure patients," noted Gary F. Burbach, president and chief executive officer of Thoratec. "Those who now have access to the device owe a great deal to the patients and clinicians who participated in this landmark trial.

"As the data from both the trial and the BTT commercial experience with the device demonstrate, the HeartMate II is a proven therapy that extends patients' lives while providing them a significantly improved quality of life. We have been laying the groundwork for the DT launch through both our device manufacturing initiatives and market development programs targeted to clinicians and the 76 centers that have received certification from Centers for Medicare and Medicaid Services (CMS) for DT reimbursement. In addition, this approval will facilitate our initiatives to build upon our already strong presence in Europe," he added.

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