Thoratec (NSDQ:THOR) said it got the go-ahead from the FDA to market its HeartMate II pocket controller.
The pocket controller is designed to support the active lifestyles of patients with HeartMate II left ventricular assist devices, the Pleasanton, Calif.-based medical device company stated in a press release.
"In offering HeartMate II LVAD patients our next-generation pocket controller device, we are providing a product that has been extensively tested and is designed for greater ease of use and safety," CEO Gary Burbach said in a press statement. "We have a significant amount of clinical experience and patient feedback from Europe that has highlighted the pocket controller’s ability to deliver meaningful benefits in everyday living with this therapy."
Clinical testing of HeartMate II LVAD has shown that over 80% of recipients became virtually free of heart failure symptoms shortly after implant and sustained those improvements for the full 2-year follow-up period, Thoratec noted.
Thoratec will begin training U.S. implanting centers on its pocket controller next week. Following clinician training, the pocket controller will be available for new patients as well as for current HeartMate II patients eligible to upgrade their existing system controllers, the company said.
The company added that over 14,000 patients have been implanted with HeartMate II, including over 6,000 currently on support. HeartMate II is the only continuous-flow LVAD approved by the the FDA for both Bridge-to-Transplantation and Destination Therapy, or permanent support.
"Patients are living for extended periods of time on HeartMate II support, either while they wait for a transplant or as a long-term, destination therapy," Burbach said. "The launch of the pocket controller provides an attractive option for these patients and advances Thoratec’s mission, which is to improve the lives of individuals suffering from advanced heart failure."
