May 7, 2007 — Thoratec Corp., a global maker of products to treat cardiovascular disease, says the FDA has approved an IDE (Investigational Device Exemption) supplement that allows enrollment of up to an additional 60 patients in the Bridge-to-Transplantation (BTT) arm of the company's HeartMate II Phase II trial under a Continued Access Protocol (CAP).
This is the third CAP the company has received for this trial, and the company recently received CAP approval for the Destination Therapy (DT) arm of the trial.
The original trial design for the BTT arm called for enrollment of 133 patients. As of April 27, 2007, the company reported that it had enrolled 296 patients in the BTT arm of the study. The original DT trial design called for enrollment of 200 randomized patients. As of April 27, 2007, 188 patients had been enrolled in the randomized arm of the trial.
The CAP patients will be enrolled and followed under the original protocol of the pivotal trial. The addition of these patients will not impact the timing for the company's planned submission of a PMA (PreMarket Approval) Amendment seeking FDA approval of the HeartMate II for the BTT indication.
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.
For more information visit www.thoratec.com or http://www.itcmed.com