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|Thoratec Corporation incorporated in the State of California in 1976 provides mechanical circulatory support with a product portfolio to treat the full range of clinical needs for advanced heart failure patients. It develops, manufactures and markets proprietary medical devices used for circulatory support. Following the sale of ITC in 2010, the Company has one operating segment: Cardiovascular group. This segment is organized and operates to develop and manufacture mechanical circulatory products to support the cardiovascular systems of humans. The Company’s VAD products primarily serve patients suffering from late-stage HF. HF is a chronic disease that occurs when degeneration of the heart muscle reduces the pumping power of the heart, causing the heart to become too weak to pump blood at a level sufficient to meet the body's demands. Hospitals that perform open heart surgery and heart transplants are the potential customers for its Thoratec and HeartMate products. The Company estimates that it sells into 293 of these centers. According to the Company’s estimates, it is in approximately 149 centers in the United States and 144 centers internationally. Competition from medical device companies and medical device divisions of healthcare companies, pharmaceutical companies and gene- and cell-based therapies is intense and is expected to increase. It therefore continues to expect new competitors both from the pharmacological and the medical device space. Among the medical device competitors are Terumo Heart, Inc., HeartWare International Inc., AbioMed, Inc., Jarvik Heart, Inc., MicroMed Technology, Inc., SynCardia Systems, Inc., CirculLite, Aachen Innovative Solutions GmbH, and WorldHeart Corporation in the U.S. and Europe and Berlin Heart GmbH in Europe. All of the Company’s proposed products will require regulatory approval prior to commercialization. In particular, medical devices are subject to rigorous pre-clinical testing as a condition of approval by the FDA and by similar authorities in foreign countries.|
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