Thoratec has announced it has filed the first two modules of its Pre-Market Approval to market its HeartMate II for bridge-to-transplantation (BTT).
The company says that of October 26, 2006, it had implanted a total of 416 patients in its Phase II pivotal trial for the next generation assist device, enrolling 97 patients during the past three months, including a record 48 patients in the Destination Therapy arm.
The updated HeartMate II pivotal trial patient enrollment includes 220 patients enrolled in the BTT arm versus 171 three months ago, and 196 Destination Therapy (DT) patients versus 148 three months ago. Of the DT patients, 113 are enrolled in the randomized portion of the trial, which means the company is now more than halfway to the 200 patient enrollment called for in the DT arm of the trial.
The company recently completed two important transactions as part of its long-term growth strategy: (1.) A distribution agreement with Levitronix under which Thoratec will distribute the Levitronix CentriMag Blood Pumping System in the U.S. The device is used for short-term support of patients requiring extracorporeal circulatory support during cardiac surgery in the U.S. (2.) The company's ITC division acquired A-VOX Systems, a leading manufacturer of point-of-care (POC) instruments and disposables used in co-oximetry testing. This transaction increases ITC's presence in the hospital POC market, including the cath lab, operating room and intensive care unit.