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FDA approves Thoratec’s HeartMate II Pocket Controller

The US Food and Drug Administration (FDA) has approved Thoratec's HeartMate II Pocket Controller, the safe face of the HeartMate II LVAD System.

The Pocket Controller is lighter and compact than the previous LVAD system controllers, and features an intuitive user interface with enhanced information content.

The Pocket Controller has been designed for the patient safety, through prioritized visual alarms, on-screen instructions, and a backup battery.

Thoratec president and CEO Gary Burbach said that in offering HeartMate II LVAD patients the next-generation Pocket Controller device, the company is providing a product that has been tested and designed for greater ease of use and safety.

"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 added.

"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."