Paracor Medical Announces Award of CE Mark
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SUNNYVALE, Calif.--(Business Wire)-- Paracor Medical, Inc. announced today that it has received CE mark approval from its notified body, BSI, for the initial two products based upon its HeartNet(TM) technology platform. The approval will allow the expanded use of Paracor's HeartNet and HeartNet-D products to treat patients suffering from systolic heart failure within the member countries of the European Union. The HeartNet implant, an elastic nitinol structure, provides support to the walls of the heart's pumping chambers, the ventricles. This elastic support augments the function of the heart, and is designed to attenuate or reverse the negative remodeling, or enlargement, associated with the advanced stages of heart failure. The second product, HeartNet-D, incorporates defibrillation electrodes within the elastic structure of the device, providing the potential to address arrhythmia problems that can be life-threatening to heart failure patients. The HeartNet-D is compatible with the leading commercially available implantable defibrillation systems. Both products are delivered in a procedure typically lasting about one hour through a less invasive mini-thoracotomy approach, avoiding some of the problems associated with cardiac procedures that employ an open chest or sternotomy procedure. The CE mark application was approved based upon clinical studies assessing the impact of HeartNet and HeartNet -D therapy in more than fifty patients. The studies indicated that, on average, treated patients experienced statistically significant improvements in structural parameters (left ventricular end systolic and diastolic diameters, left ventricular volumes), exercise parameters (6 minute walk), and quality of life measures (Minnesota Living with Heart Failure instrument) through six months of follow-up, with continuing positive trends at the twelve month time frame. In addition, patients treated with the HeartNet-D therapy maintained appropriate defibrillation safety margins through six months of follow-up testing. In commenting on the CE mark certification, William G. Mavity, Paracor Medical's President and CEO, noted, "We are extremely pleased to have succeeded in obtaining this significant approval, as it indicates compliance with applicable development, manufacturing and quality standards that are recognized globally. Over the coming months, we will be considering appropriate strategies to enable the Company to leverage the CE mark status of our products and broaden the clinical acceptance of the HeartNet therapy." Paracor Medical is currently evaluating the HeartNet therapy in an FDA approved clinical trial in North America that intends to enroll more than 270 treatment and control patients. Designated PEERLESS-HF (Prospective Evaluation of Elastic Restraint to LESSen the effects of Heart Failure), the trial will compare the impact of the HeartNet treatment plus optimal medical and device therapy, per current guidelines, to results in patients who continue to receive optimal therapy alone. The American Heart Association estimates that 5.3 million U.S. persons have been diagnosed with heart failure, with more than 500,000 newly diagnosed patients each year. Heart failure is a leading cause of U.S. hospital admissions, and only about half of heart failure patients will survive more than five years. A European survey indicated that 10 million people suffer from heart failure in countries represented by the European Society of Cardiology. Paracor Medical, Inc. is a venture capital financed medical technology company focused on the development of a platform of technologies and products to treat heart failure. Based in Sunnyvale, CA, the company was founded in 1999. Its website is www.paracor.com. Paracor Medical William Mavity, 408-734-6030 Chief Executive Officer Copyright Business Wire 2008
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