Thoratec Corporation said that the FDA has approved its PMA (PreMarket Approval) Supplement to consolidate its cardiovascular device manufacturing activities at the company's Pleasanton, California headquarters.

As a result, the company will now manufacture its HeartMate LVAS (left ventricular assist system) devices in Pleasanton, ending manufacturing activities at a facility in Woburn, Massachusetts that Thoratec acquired through its merger with ThermoCardiosystems approximately two years ago. Thoratec will maintain a substantial research and development, marketing and clinical/regulatory affairs presence in the Woburn, Massachusetts facility, however. In November, 2002, the HeartMate VE-SNAP LVAS was approved by the FDA as the first and, to date, only heart assist device for Destination Therapy, or permanent support for patients suffering from end-stage heart failure who are not eligible for heart transplantation.

"As we indicated after the merger closed, the ability to have all of our ventricular assist device manufacturing efforts in one location will create additional synergies for our current activities, as well as enhance our efforts to develop next generation devices," said D. Keith Grossman, president and chief executive officer of Thoratec. "This approval marks the culmination of a highly successful integration effort between the two companies. The speed and ease with which it was accomplished is a testimony to the professionalism and dedication of all our employees," he added.