ATS Medical, a manufacturer and marketer of cardiac surgery medical devices, said that Health Canada-Medical Device Bureau, Therapeutic Products Programme has approved commercialization of the ATS Simulus Annuloplasty Product Line for valve repair.
The approval expands the growth opportunity for ATS Medical in Canada and will be further complemented by the addition of a new distribution partner, Canadian Hospital Specialties. They have formed a new cardiac surgery division and have added three experienced cardiac surgery specialists focused on driving the adoption of the ATS product portfolio.
The Simulus product portfolio includes flexible, semi-rigid and adjustable annuloplasty rings and bands for use in mitral and tricuspid valve repair. Valve repair, as opposed to valve replacement, has been established as the gold standard of therapy for diseased or damaged mitral valves.
Simulus annuloplasty products are designed to provide physiologic support for the repaired valve, adapting to the natural movement of the heart in the cardiac cycle. In addition, the Simulus product line provides handling characteristics that are recognized and appreciated by cardiac surgeons.
Michael Dale, president and CEO of ATS Medical, said: “ATS looks forward to collaboration with Canadian Hospital Specialties to introduce the ATS Simulus product line to the Canadian surgical community. The new partnership will allow us reach key opinion leaders in cardiac surgery and more fully penetrate the Canadian marketplace.”