May 23, 2007 —Thoratec Corp. has announced it has completed enrollment in the randomized portion of the Destination Therapy (DT) arm of its Pivotal trial for the HeartMate II by enrolling 200 patients on a randomized basis as called for in the trial protocol.
The company had announced May 3 the FDA approved a Continued Access Protocol (CAP) to enroll an additional 60 patients in the DT arm. The company also recently received a CAP to enroll an additional 60 patients in the Bridge-to-Transplantation (BTT) arm of the trial. The CAP patients in both arms will be enrolled and followed under the original protocols of their respective clinical trials.
The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients. An implantable LVAS (Left Ventricular Assist System) powered by a rotary pumping mechanism, the HeartMate II is designed to have a much longer functional life than pulsatile devices and to operate more simply and quietly. The device provides blood flow through the circulatory system on a continuous basis with only one moving part. It is also smaller and easier to implant than pulsatile devices.