FDA green lights LVAD pocket controller

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The FDA has approved the HeartMate II Pocket Controller, which is designed to enhance ease and safety for users of the HeartMate II left ventricular assist device (LVAD) system.

According to Pleasanton, Calif.-based Thoratec, the next generation pocket controller is lighter, smaller and easier to use than its predecessors. Features include prioritized visual alarms, on-screen instructions and a backup battery. It fits within a front pocket.

Physician training at centers that perform implants is to begin now. Once trained, physicians will be able to offer the pocket controller to new patients as well as upgrades to patients with HeartMate II LVADs.