Thoratec Corporation announced 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 US 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 an amendment to the submission once we have complete two-year data on the primary patient cohort," said Gary F. Burbach, president and chief executive officer of Thoratec. Thoratec received approval from the FDA in December 2008 to end randomization in the trial, based on a pre-specified interim analysis of 67 percent of the first 200 patients that showed that patients implanted with the HeartMate II achieved statistically superior outcomes versus those in the control group who were implanted with the HeartMate XVE. Based on that analysis, the study's Data Safety Monitoring Board concurred with Thoratec's recommendation to eliminate randomization for patients enrolled in the trial under FDA-approved CAPs. Patients in the trial were randomized to the HeartMate II or the HeartMate XVE -- currently the only device approved for DT on a 2-1 basis, respectively. The primary endpoint at two years is survival while remaining free from stroke and the need for reoperation for pump repair or replacement. Secondary endpoints included adverse events, functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life. "The data from the trial demonstrate that the HeartMate II is superior to the XVE, based on device performance and the primary patient outcome of two-year survival free from stroke and reoperation for device replacement. The data also showed that key adverse events, such as infection, sepsis and right heart failure, were significantly lower for the HeartMate II versus the XVE. As a result, this submission seeking FDA approval for Destination Therapy is an important milestone in Thoratec's mission to bring breakthrough therapies and new hope to the thousands of patients and their families suffering from advanced heart failure, as well as the clinicians who work tirelessly to treat them," Burbach said. "The commercial experience of the HeartMate II for BTT over the past year has been very encouraging with respect to positive patient outcomes and increased adoption by the clinical community. We look forward to working with the FDA on this submission and hope to achieve DT approval by early 2010," he added.