2014

Thoratec Surpasses 10,000 HeartMate II® Implants Worldwide Treatment Option Provides Hope For Advanced Heart Failure Patients

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.

About Thoratec

Thoratec is the world leader in mechanical circulatory support with the broadest product portfolio to treat the full range of clinical needs for patients suffering from advanced heart failure. The company's products include the HeartMate LVAS and Thoratec VAD, with more than 18,000 devices implanted in patients suffering from heart failure.  Thoratec also manufactures and distributes the CentriMag® and PediMag® / PediVAS® product lines.  Thoratec is headquartered in Pleasanton, California. For more information, visit www.thoratec.com.

Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation and IVAD is a trademark of Thoratec Corporation.  CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH.

Many of the preceding paragraphs, particularly but not exclusively those addressing the company's current expected timelines for product development, clinical trials and commercialization, contain forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, "believes," "views," "expects," "plans," "projects," "hopes," "could," "will," "should," and other similar words. Forward-looking statements should not be read as a guarantee of future performance or results, and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on Form 10-K as may be updated in subsequent SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

[1] Rose E., et. al. Long-Term Use of a Left Ventricular Assist Device for End-Stage Heart Failure. N Engl J Med 2001; 345: 1435-43.

[2] Rogers JC, et. al. Chronic Mechanical Circulatory Support for Inotrope-Dependent Heart Failure Patients Who Are Not Transplant Candidates: Results of the INTrEPID Trial. J Amer Coll Cardiol 2007; 50:741-7.

[3] Pagani FD, Miller LW, Russell SD, et al. Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device. J Amer Coll Cardiol 2009;54(4):312-321.

[4] Park, S., et. al. Outcomes in Advanced Heart Failure Patients with Left Ventricular Assist Devices for Destination Therapy. Circ Heart Fail 2012.

[5] Pagani FD, Miller LW, Russell SD, et al. Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device. J Amer Coll Cardiol 2009;54(4):312-321.

SOURCE Thoratec Corporation



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