TS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services today announced it has received CE Mark approval to distribute the ATS 3f Enable® Aortic Bioprosthesis in the European Union, indicating it is compliant with relevant European health, safety, and environmental protection legislation. 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 novel 3f tubular pericardial valve design with its superior hemodynamic profiles and a self-expanding frame to hold the valve in its optimal position.
The goal of the Enable valve is to achieve a less invasive aortic valve replacement and reduce procedure times. Today, most aortic valve surgery cannot be done on a minimally invasive basis because precise suturing is difficult within the confined space of a minimally invasive procedure. 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.
Professor Jerzy Sadowski MD, PhD, Jagiellonian University, Department of CV Surgery and Transplantology, Krakow, Poland said, We have been implanting the ATS Enable valve for four years achieving excellent hemodynamic and safety results. This valve is an important step toward the goal of reducing procedure time and allowing for a more minimally invasive approach to conventional valve surgery.