Thoratec Announces FDA Approval Of HeartMate II Pocket Controller
PLEASANTON, Calif., May 17, 2013 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the HeartMate II® Pocket Controller™, the small, smart, safe face of the HeartMate II LVAD System.
"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," said Gary F. Burbach , President and Chief Executive Officer. "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."
The Pocket Controller is designed to support the active lifestyles that patients with HeartMate II LVADs are leading. The Pocket Controller is lighter and more compact than previous LVAD system controllers, and it features an intuitive user interface with enhanced information content. Additionally, with a single-side cable design, the device can slide easily and discreetly into a front pocket. The Pocket Controller has also been designed to promote patient safety, through features including prioritized visual alarms, on-screen instructions, and a backup battery, which can provide at least 15 minutes of full power during periods of inadvertent disconnections from power sources.
"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," noted Burbach. "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."
Thoratec will begin training U.S. implanting centers on the Pocket Controller during the week of May 20th. 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. Patients should contact their centers to learn more about the HeartMate II system and the new Pocket Controller. To find an implant center near you, please visit www.hearthope.com.