PLEASANTON, Calif., April 20 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has filed a PMA (Pre-Market Approval) supplement with the FDA seeking to add the intended use of Destination Therapy (DT) for the HeartMate II LVAS (left ventricular assist system). The HeartMate II is a next generation heart assist device designed to provide long-term cardiac support for patients suffering from advanced stage heart failure. The device was approved for Bridge-to-Transplantation (BTT) in the U.S. under the original PMA in April 2008.
The PMA filing includes data on a pivotal study cohort of 200 randomized patients, including two-year data on the first 167 patients enrolled. Also included in the primary analysis are 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 provides data on adjunctive cohorts totaling an additional 409 patients, including those who had been originally supported by an XVE who then elected to receive a HeartMate II, based on the need for device replacement, and patients enrolled under Continuous Access Protocols (CAPs). The company plans to file an amendment to the PMA supplement submission with complete two-year data on all 200 randomized patients at the end of June.
"We are pursuing this approach and making this submission at this time based on a series of discussions with the FDA. An interim analysis conducted at the end of 2008 for the primary endpoint demonstrated statistically significant superiority in favor of the HeartMate II versus the control group. As a result, Thoratec and the FDA have agreed that it is appropriate to make this filing now and to then file
|SOURCE Thoratec Corporation|
Copyright©2009 PR Newswire.
All rights reserved