CorMatrix® Cardiovascular, Inc. issued the following announcement on June 11.
CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, announced FDA 510(k) clearance for the Cor™ PATCH. The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients. The Cor™ PATCH epicardial patch is the first epicardial cardiovascular medical device composed of first next generation CorMatrix® ECM® to be cleared by the FDA and introduced into the US cardiac surgery market. The applications and clinical description of uses include the epicardial support and repair of atria and/or the right and left ventricular walls of the heart that have been thinned or damaged as a result of myocardial infarct. The Cor™ PATCH is first in a series of products to address clinical challenges in the cardiovascular disease market, to include regenerative and innovative design solutions for congestive heart failure, and adult or pediatric cardiac valve patients.
"We have a unique opportunity to enhance the repair and recovery of heart muscle after injury using the Cor™ PATCH technology. This could be a game changer for patients undergoing surgical procedures aimed to increase the blood supply to damaged areas of their heart. My translational research provides an important foundation of data to support the clinical use of this technology as an epicardial patch during coronary bypass surgery. We can now directly target damaged muscle in addition to bypassing blocked vessels," said Dr. Paul W.M. Fedak, Professor of Cardiac Surgery, Cumming School of Medicine, University of Calgary, Libin Cardiovascular Institute of Alberta.
"The ECM® technology and our knowledge of the underlying physiological mechanisms for regeneration continues to rapidly grow. The Cor™ PATCH represents our entry into epicardial tissue repair and support. Our pipeline is becoming full of some very compelling products," said Robert G Matheny, MD Chief Medical & Scientific Officer, CorMatrix® Cardiovascular Inc.
"The Cor™ PATCH is the first next generation ECM® product cleared by the FDA for epicardial tissue support and repair. The introduction of the Cor™ PATCH epicardial patch to the cardiac surgery market represents the first of a rapidly developing CorMatrix® pipeline of next generation ECM® products and patient solutions," said Edgar Rey, President & CEO, CorMatrix® Cardiovascular Inc.
CorMatrix® Cardiovascular, Inc. is a regenerative biotechnology company based in metro Atlanta, Georgia. A pioneer and leader in regenerative science and technology, the company was founded to address congestive heart failure, the largest global disease management challenge and unmet cardiovascular clinical need. CorMatrix® provides regenerative, technological innovations, and patient solutions for the treatment of congestive heart failure and other cardiovascular diseases. The company is committed to developing innovative future non-synthetic, regenerative devices for the cardiovascular system through continued research and improvements to the CorMatrix® ECM® technology.
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