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-based procedure, said in a prepared statement.
Approval of the system was supported by data from a clinical study of the device and associated procedure which was published in the journal EuroIntervention this month, the company said.
Data from the trial demonstrated the device was safe and effective during the percutaneous placement of sutures in the heart, HeartStitch said.
“We have worked very hard to bring these ideas through the development stages. Our top engineers collaborating from our offices in Germany, Kazakhstan and the US were responsible for creating this historic device. We now look forward to increasing our world presence as a leader in suture based structural heart market,” manufacturing & operations VP Dru Dobbs said in a press release.
Earlier this week, HeartStitch said that its HeartStitch Remo Pro suture technique was used in a world first procedure to repair the tricuspid valve of two patients as part of a feasibility trial of the technique and the supporting technology.