Thoratec receives FDA nod for HeartMate II Pocket Controller

20 May 2013 (Last Updated May 20th, 2013 18:30)

Thoratec Corporation has received approval from the US Food and Drug Administration (FDA) to market the company's small, safe face of the HeartMate II LVAD System, the HeartMate II Pocket Controller.

Thoratec Corporation has received approval from the US Food and Drug Administration (FDA) to market the company’s small, safe face of the HeartMate II LVAD System, the HeartMate II Pocket Controller.

The HeartMate II Pocket Controller, which is more compact than the previous LVAD system controllers, features an intuitive user interface with improved information content.

The Pocket Controller, with a single-side cable design, is expected to support the active lifestyles that patients are leading with HeartMate II LVADs.

The device encourages patient safety with its features that include prioritised visual alarms, on-screen instructions, and a backup battery to offer full power for at least 15 minutes during periods of inadvertent disconnections from power sources.

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

"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," 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."