PLEASONTON, Calif.-Thoratec Laboratories, based here, is continuing to make inroads with its portable driver that powers its ventricular assist device (VAD), allowing patients awaiting heart transplantation to leave the hospital.
The TLC-II Portable VAD Driver was approved in September for commercial release in Canada. The driver can be used interchangeably with Thoratec's VAD System, which is already marketed in Canada as a bridge to transplantation, Thoratec said in a statement.
Thoratec also announced the submission of an investigational device exemption application for the portable driver with the Food and Drug Administration. Pending approval of the IDE, Thoratec plans to begin clinical trials in six to eight transplant centers in the United States later this year.
The driver is already being sold in Europe.
According to Thoratec, the driver is the only portable cardiac assist device that can treat all patients by providing right, left, or biventricular support.
In other Thoratec news, the company announced that it has initiated enrollment into its U.S. clinical trials of its Vectra vascular access graft. Vectra provides access to the blood in patients with renal failure who are undergoing hemodialysis. It permits dialysis to begin almost immediately after implantation, which obviates the need for a secondary central catheter. Thoratec said that the ability for almost immediate dialysis "represents the first significant innovation in vascular graft technology in years."
Vectra is currently available in Japan, Australia, and Canada and has been cleared for European sales.
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Thoratec Laboratories
6035 Stoneridge Drive, Pleasanton, CA 94588
925-847-8600 (phone)
http://www.thoratec.com/
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