MINNEAPOLIS, Dec. 7 /PRNewswire-FirstCall/ -- ATS 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(R) 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.
“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.
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.
ATS Medical, Inc. is dedicated to ‘Advancing The Standards’ of cardiac surgery through the development, manufacturing and marketing of innovative products and services for the treatment of structural heart disease. ATS Medical serves the cardiac surgery community by focusing on two distinct but operationally synergistic market segments: heart valve disease therapy and surgical ablation of cardiac arrhythmias.
Safe Harbor
ATS Medical, Inc.
