HeartStitch has secured CE mark approval for its minimally invasive trans-apical access and closure device.
HeartStitch trans-apical access and closure device provides safe and effective percutaneous trans-apical access for structural heart procedures and reliable closure.
The proven suture-based technique emulates surgical closure without the need for open heart surgery or limited thoracotomy access (open surgical access to the heart between the ribs) when repairing structural heart defects in the left heart.
The HeartStitch® technology for Trans-Apical 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 PFO 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.
HeartStitch chairman, CEO and chief clinical specialist professor Anthony Nobles 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."
HeartStitch® Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the structural heart marketplace. HeartStitch® is focused on the innovative suture-based systems for remotely providing suture repair of structural heart defects and other vascular structures.
HeartStitch® currently markets the NobleStitch™ EL under license the NobleStitch™ EL device for cardiovascular suturing and PFO closure. HeartStitch™ develops new structural heart technologies through its international innovation development teams in California, Kazakhstan and Germany.