Thoratec Comments on HeartMate II Clinical Study Filing

Thoratec commented on its investigational device exemption (IDE) application to the FDA to conduct a Phase II pivotal clinical trial for the company's HeartMate II.

The HeartMate II is the company's next generation left ventricular assist device designed to provide long-term cardiac support for patients who are in end-stage heart failure. Thoratec completed its Phase I study for the device in August 2004. It included 25 bridge-to-transplantation patients at 10 centers who have now accumulated approximately six years of total support. There have been no serious device-related adverse events or mechanical failures.

The company said it is continuing to have discussions with the FDA regarding certain elements of the study's design. Based on the nature of those items still under discussion the company continues to have a high degree of confidence in a pivotal trial approval, which the company hopes will occur sometime in the next 15 to 45 days.