ATS Medical has reported that the first commercial implants of the ATS 3f Enable Aortic Bioprosthesis were performed at the University of Berne Hospital, Berne, Switzerland. The procedures were completed using a sutureless technique and the patients are recovering with no complications.
The company claims that the ATS 3f Enable valve is the first surgical aortic valve replacement approved for commercial use that is implanted using a sutureless technique. The Enable valve combines the ATS 3f Aortic Bioprosthesis with over eight years of proven clinical performance and a self-expanding Nitinol frame to hold the valve in its optimal position eliminating the need for conventional sutures.
Thierry Carrel, professor, chief of Cardiac Surgery at the University of Berne, said: “The implants went smoothly. There were no paravalvular leaks and the valves provide excellent hemodynamic performance with low single digit gradients. The Enable valve will help us expand our number of minimally invasive procedures.
“The Enable valve proves to be a true competitor for TAVI (Transcatheter Aortic Valve Implantation) because the diseased valve is removed, we can directly visualize the placement of the new valve thereby obtaining clinical outcomes similar to conventional procedures. TAVI can be considered palliative whereas Enable is restorative.”
Michael Dale, president and CEO of ATS Medical, said: “These landmark procedures in Switzerland are a major milestone for the Enable platform with the goal of bringing this disruptive technology to the traditional surgical market. Ultimately we envision the Enable platform facilitating minimally invasive procedures for patients without compromising conventional surgical valve outcomes.”