http://pleasantonweekly.com/print/story/print/2013/05/24/thoratec-gains-fda-approval-for-its-new-heartmate-pocket-controller


Pleasanton Weekly

- May 24, 2013

Thoratec gains FDA approval for its new Heartmate Pocket Controller

Device can slide easily, discreetly into front pocket

by Jeb Bing

Thoratec Corp., a Pleasanton-based designer and manufacturer of device-based mechanical circulatory support therapies, has received approval from the U.S. Food and Drug Administration to market the HeartMate II Pocket Controller, a smaller version of its HeartMate II LVAD system.

The device saves, supports and restores failing hearts, company representatives said.

"In offering 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," he added.

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," 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."

Thoratec began training U.S. implanting centers on the Pocket Controller this 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.

About HeartMate II

HeartMate II is the most widely used and extensively studied LVAD in the world. Featuring innovative design elements, including proprietary textured surfaces, blood immersed ruby bearings and open flow paths,

Thoratec's HeartMate II has proven to be a highly durable device capable of long-term circulatory support. In clinical testing, over 80% of HeartMate II recipients became virtually free of heart failure symptoms shortly after implant and sustained those improvements for the full two-year follow-up period. Moreover, controlled clinical trials as well as large-scale commercial experience have demonstrated significant improvement in patients' functional capacity, with 94% of HeartMate II recipients able to perform the six-minute walk test after six months of support.

To date, more than 14,000 patients have been implanted with HeartMate II, including more than 6,000 currently on support.

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