ATS Medical's ATS 3f Enable Aortic Bioprosthesis receives European CE Mark approval

Dec 7 2009

ATS Medical, Inc. (Nasdaq: ATSI), 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.

"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," stated Professor Jerzy Sadowski MD, PhD, Jagiellonian University, Department of CV Surgery and Transplantology, Krakow, Poland. Professor Sadowski and his surgical team performed the first human implant of the Enable valve in January 2005.

"We are very excited to obtain the world's first approval for a surgical sutureless heart valve. This initial offering in the Enable platform is an important first step in bringing disruptive technology to the traditional surgical market. Ultimately, we envision the Enable platform facilitating minimally invasive procedures for patients with conventional surgical indications," stated Michael Dale, President and CEO of ATS Medical. "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."

Commercialization of the Enable valve will commence 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 state-of-the-art techniques used for implanting the Enable valve and will be instrumental in the development and launch of future generations of the ATS 3f Enable platform. Release of the second generation Enable is expected in the latter half of 2010.

The Company is continuing to develop sutureless tissue valve technology for use in beating heart procedures based in part on the characteristics of the next generation of Enable valves. First-in-man studies of these novel technologies are targeted for 2010. Commercialization of a beating heart solution could occur within one to two years thereafter. A valve compatible in beating heart procedures would enlarge the Company's market opportunity by providing a solution for those patients who are poor candidates to endure conventional surgery.