To distribute Bioprosthesis in the EU
ATS Medical has received CE Mark approval to distribute the ATS 3f Enable Aortic Bioprosthesis in the EU, indicating it is compliant with relevant European health, safety, and environmental protection legislation.
The company claims that the Enable valve is the first surgical aortic valve replacement approved for commercial use that is implanted using a sutureless technique. It is the first valve of the ATS 3f Enable platform which combines the 3f tubular pericardial valve design with its superior hemodynamic profiles and a self-expanding frame to hold the valve in its optimal position.
The company also said that the goal of the Enable valve is to achieve a less invasive aortic valve replacement and reduce procedure times. The sutureless Enable valve can be folded into a small diameter to allow placement through a minimally invasive incision. Once the Enable valve is delivered to the site of the annulus, it is expanded to its preconfigured diameter and is held in place with a resistance fit.
Commercialisation of the Enable valve will begin with a controlled market release at select surgical centers in Europe. These sites will serve as ‘Centers of Excellence’ where surgeons throughout Europe will be trained in the techniques used for implanting the Enable valve.
Michael Dale, president and CEO of ATS Medical, said: “This initial offering in the Enable platform is a first step in bringing technology to the traditional surgical market. Ultimately, we envision the Enable platform facilitating minimally invasive procedures for patients with conventional surgical indications.
“Additionally, by reducing procedural time and the trauma incurred with current conventional surgical procedures, we believe Enable may also become a viable solution for certain patients who are currently considered too sick for surgery.”