Thoratec receives commercial approval for HeartMate II in Europe

By Angela McDaniels

Seattle, Nov. 7 - Thoratec Corp. said it has received approval to launch its HeartMate II cardiac assist device in Europe.

The product is designed to provide long-term support for patients in advanced-stage heart failure, and the company said it expects to initiate sales before the end of the year.

The regulatory application for European approval was based on data from the company's U.S. phase-1 study, which involved 20 patients, and a European study.

Thoratec said the device is currently undergoing a phase-2 clinical trial in the United States for destination therapy and bridge-to-transplantation therapy.

The bridge-to-transplantation arm will involve 133 patients in total, with the primary endpoint being the rate of survival to transplantation, or 180 days.

The destination therapy arm of the study will involve 200 total patients and will provide a composite two-year endpoint, which includes patient survival, rate of neurological events and device reliability.

"The HeartMate II has generated a high level of interest among clinicians in Europe due to the positive patient experience and ease of implant. With this approval, we now have four cardiac assist devices approved for sale in Europe, enabling us to offer clinicians both short and long-term treatment

options for patients with heart failure," said Jeffrey Nelson, president of Thoratec's cardiovascular division, in a company press release.

Thoratec is based in Pleasanton, Calif., where it develops hemodynamic restoration therapy products for the treatment of cardiovascular disease.

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