Thoratec Corporation 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 20^th. 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.
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