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ANGIOSCORE, INC. ANNOUNCES INITIATION OF U.S. CLINICAL TRIAL FOR THE ANGIOSCULPT SCORING CATHETER ALAMEDA, CA - August 26, 2004 - AngioScore™, Inc., a developer of novel tools for interventional cardiology, announced today the receipt of approval from the US Food & Drug Administration to begin the US clinical trial for its flagship AngioSculpt™ scoring catheter and the initiation of patient enrollment in the trial. The clinical trial is led by study principal investigator Dr. Martin Leon of Columbia University. The US clinical trial is a prospective clinical study of the safety and efficacy of the AngioSculpt scoring catheter in 200 patients undergoing angioplasty to treat coronary artery disease. The study examines acute outcomes when the AngioSculpt scoring catheter is used for the treatment of a hemodynamically significant coronary artery stenosis, including in-stent restenosis, for the purpose of improving myocardial perfusion. Study enrollment commenced at the Minneapolis Heart Institute under the direction of its Director of Interventional Cardiology, Dr. Michael Mooney. Commented Dr. Mooney, "There is a clinical need for a safer and more deliverable device that can treat complex lesions. Treatment of these lesions can be complicated by challenging anatomy that makes catheter delivery difficult, balloon slippage leading to "geographic miss", elastic recoil and the need to use high pressures to open lesions. The AngioSculpt scoring catheter is a promising new device that may help interventional cardiologists in treating a wide variety of lesions." The study is being conducted at multiple centers. In addition to the Minneapolis Heart Institute these include Brigham and Women's Hospital, Columbia University, Scripps Clinic, Stanford University Medical Center, Swedish Medical Center and Washington Hospital Center. Commented Gary Gershony, MD, FACC, AngioScore's Chief Medical Officer "The participation of these well respected institutions in the US clinical trial is a testament to the AngioSculpt scoring catheter's innovation and expected clinical benefits. The AngioSculpt scoring catheter can potentially improve outcomes in over half of the 1.2 million angioplasties performed annually in the United States. The AngioSculpt scoring catheter is comprised of an angioplasty balloon surrounded by a unique system of nitinol struts that score arterial lesions as the balloon expands to open the target artery during angioplasty. It is designed for use on a routine basis in most predilatation cases. The AngioSculpt scoring catheter scores plaques without using the sharp blades that are employed in competitive cutting devices. The AngioSculpt scoring catheter has the potential to improve results in more than half of the 2.2 million angioplasties performed annually worldwide. About Angioscore AngioScore, Inc. (www.angioscore.com) is an interventional cardiology company located in Alameda, California. The company's first product is the AngioSculpt scoring catheter. AngioSculpt is an investigational device. AngioScore can be contacted at +1-510-263-0480 or info@angioscore.com. This press release contains forward-looking statements that are based upon management's current expectations and are inherently uncertain. Forward-looking statements are based upon information available to us as of the date of this press release and we assume no obligation to revise or update any such forward looking statement to reflect any event or circumstance after the date of this release. Actual results and the timing of events could differ materially from current expectations and from any forward-looking statements made by the company. |
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