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http://www.sacbee.com/2012/04/17/4420081/thoratec-surpasses-10000-heartmate.html
Thoratec Surpasses 10,000 HeartMate II® Implants Worldwide

Treatment Option Provides Hope For Advanced Heart Failure Patients

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By Thoratec Corporation







Published: Tuesday, Apr. 17, 2012 - 5:42 am




PLEASANTON, Calif., April 17, 2012 -- /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support (MCS) therapies to save, support and restore failing hearts, today announced that as of April 2012, clinicians have implanted more than 10,000 HeartMate II® Left Ventricular Assist Devices (LVADs) in patients suffering from advanced heart failure (AHF) worldwide.

The HeartMate II is a small implantable mechanical device that helps circulate blood throughout the body. Sometimes called a "heart pump" or "VAD," it is designed to supplement the pumping function of the heart for patients whose hearts are too weak to pump blood adequately on their own.

"Every year, millions of people worldwide develop chronic heart failure, and many will progress to an advanced, debilitating stage of the disease," said Gary Burbach, President and Chief Executive Officer of Thoratec. "Today, we recognize the more than 10,000 individuals who have been implanted with HeartMate II – the device that is setting the standard for proven, long-term support of advanced heart failure patients. I want to congratulate and thank everyone involved for contributing to this milestone event. This is a great achievement for the medical community and, most importantly, for the patients who have benefited from this life-restoring treatment option."

HeartMate II has been extensively studied, both in clinical trials and in commercial, real-world experience, and has been approved by the U.S. Food and Drug Administration (FDA) as well as international regulatory bodies to support advanced heart failure patients. For individuals with AHF, the heart has difficulty pumping blood and is unable to supply the body with adequate levels of oxygen. As a result, AHF patients feel tired or weak, even when doing simple things, like walking or eating. The use of an LVAD, such as the HeartMate II, is considered an appropriate treatment option in cases of AHF. Studies have shown that patients treated with an LVAD can live longer and enjoy a much-improved quality of life compared with those being treated with drug therapy alone.[1],[2]

HeartMate II may be used to support patients either while they wait for a donor heart to become available or as a permanent, long-term therapy. For patients eligible for a heart transplant, usage of HeartMate II is known as "Bridge-to-Transplantation" (BTT). Utilization of the device with the intent of permanent, long-term support is known as "Destination Therapy" (DT). In either situation, without the option of an LVAD, AHF patients have poor prospects for survival and significantly limited lifestyles.[3],[4]

HeartMate II Facts:

•HeartMate II is the most widely used and extensively studied LVAD available today.
•More than 200 peer-reviewed publications have featured studies regarding the HeartMate II – far exceeding published data on all other LVADs combined.
•HeartMate II is the only available device FDA-approved for both Bridge-to-Transplantation (BTT) and Destination Therapy (DT), or long-term support.
•HeartMate II measures approximately three inches in length and weighs approximately 10 ounces. It has one moving part, a continuously spinning rotor that helps circulate blood.
•To date, HeartMate II has been implanted at over 290 medical centers across more than 35 countries in North America, Europe, the Middle East, Asia, Australia and Africa.
•The HeartMate II has demonstrated excellent and consistent outcomes in very sick patient populations. [4],[5]


For more information on advanced stage heart failure therapy or to locate a physician, visit www.hearthope.com. To read patient stories, visit www.thoratec.com/shareyourstory.

About HeartMate II

The HeartMate II is intended for a broad range of advanced heart failure patients and is the only continuous-flow left ventricular assist device (LVAD) approved by the FDA for both Bridge to Transplantation and Destination Therapy. The device is designed to provide long-term cardiac support, pumping up to 10 liters of blood per minute for full support of the circulation, or to supplement the native function of the patient's left ventricle. The HeartMate II is placed just below the diaphragm and is connected to the left ventricle, returning blood flow to the aorta, the main artery that carries oxygenated blood to the entire body. An external, wearable system that includes a small controller and two batteries is attached by an external driveline. HeartMate II is smaller and easier to implant than prior FDA-approved devices, and with only one moving part, it is designed to provide exceptional reliability and improved patient quality of life