CorMatrix® Cardiovascular, Inc. receives FDA 510 clearance to market the Cor™ PATCH epicardial patch for tissue support and repair in adult patients

美国FDA批准CorMatrix公司Cor PATCH用于心外膜组织支持和修复

2019-06-12 22:07:00 CISION


CorMatrix® Cardiovascular, Inc., a leading developer of regenerative cardiovascular medical devices, today announced FDA 510 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.
CoreMatrix ® Cardiovalar , Inc . 是再生心血管医疗设备的领先开发商,今天宣布 FDA 510批准 Core ™ PATCH 。Cor ™ PATCH 用于成人患者的心外膜组织支持和修复。Cor ™ PATCH 心包补片是第一个心包心血管医疗设备,由第一代 CorMatrix ® ECM ®组成,将由 FDA 批准并引入美国心脏手术市场。用途的应用和临床描述包括因心肌梗塞而变薄或受损的心房和/或心脏的右室和左室壁的支持和修复。Cor ™ PATCH 是一系列解决心血管疾病市场临床挑战的产品中的第一个,包括针对充血性心力衰竭的再生和创新设计解决方案,以及成人或儿科心脏瓣膜患者。 “利用 Cor ™ PATCH 技术,我们有一个独特的机会来加强损伤后心肌的修复和恢复。这可能会改变患者接受外科手术的游戏规则,目的是增加心脏受损区域的血液供应。我的转化研究提供了一个重要的数据基础,以支持临床使用这一技术作为心外径手术期间的心外膜。我们现在可以直接瞄准受损的肌肉,除了绕过阻塞的血管,”博士保罗 W.M.Fedak ,教授心脏外科, Cumming 医学院,卡尔加里大学,利宾心血管研究所艾伯塔。 “ ECM ®技术和我们对再生潜在生理机制的了解继续快速增长。Cor ™ PATCH 代表了我们进入心外膜组织修复和支持的过程。我们的管道正变得充满一些极具吸引力的产品,” CoreMatrix ®心血管公司医学与科学总监 Robert G Matheny 说。 “ Cor ™ PATCH 是 FDA 批准用于心外膜组织支持和修复的第一个下一代 ECM ®产品。CorMatrix ®心血管公司总裁兼首席执行官 Edgar Rey 表示:“将 Cor ™ PATCH 心肺补片引入心脏手术市场,是快速发展的 CorMatrix ®新一代 ECM ®产品和患者解决方案的第一条管道。”