HeartStitch wins CE Mark for Trans-Apical Access and Closure device

HeartStitch said today it won CE Mark approval in the European Union for its suture-based Trans-Apical Access and Closure device. The Trans-Apical Access and Closure device is designed to provide percutaneous trans-apical access for structural heart procedures and closures. The system emulates surgical closure without need for open heart surgery or limited thoractomy access during left-heart structural heart defect repairs, the company said. “The CE Mark approval is another major step in the continuing process of establishing HeartStitch in the market as an innovator in the field of structural heart repair.  We strive and will continue to deliver to physicians a line of suture-based closure, repair and remodeling devices which provide the quality they demand for their patients with the ease of use they have been seeking. The ability to access the left ventricle to treat structural heart defects without surgery is a major step forward for HeartStitch. We expect to bring this product to market this fall in Europe and will follow with USA thereafter,” chair & CEO Anthony Nobles said in prepared remarks. “I am very excited about this technology and see great potential for our minimally invasive structural heart procedures. The device is revolutionary, allowing interventional procedures to be performed safely and effectively,” Dr. Yuri Pya of Astana, Kazakhstan’s National Cardiac Research Center, who performed the first HeartStitch suture...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory/Compliance HeartStitch Source Type: news