CE mark for HeartStitch’s transapical access and closure device

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A press release reports that HeartStitch transapical access and closure device provides safe and effective percutaneous transapical access for structural heart procedures and reliable closure. The suture-based technique is designed to emulate surgical closure without the need for open heart surgery or limited thoracotomy access when repairing structural heart defects in the left heart.

According to the press release, the HeartStitch technology for transapical access and closure has received significant attention from interventional cardiologists after the recent publication of the NobleStitch Italian clinical study publication in the peer reviewed EuroIntervention journal this month. The NobleStitch data demonstrated the safety and effectiveness of placing sutures percutaneously in the heart. This success in the patent foramen ovale  space has launched an increased interest in suture-based solutions that eliminate the need for open surgical procedures by giving physicians a tool that can allow access though a percutaneous puncture directly in to the heart without an incision and then use sutures to safely close the hole.

Anthony Nobles, chairman, CEO and chief clinical specialist of HeartStitch, states: “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 remodelling 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.”

Yuri Pya of the National Cardiac Research Center, Astana, Kazakhstan, who was the first in the world to perform this procedure using suture-based solution comments: “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.”

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