With the success of today's techniques for mitral valve repair, mitral valves are replaced less often than in the past. Therefore, more time has been required to attain the needed clinical experience for mitral valves. Needed additional follow-up is nearly complete and premarket approval for the mitral valve should follow quickly. On-X clinical trials began with the first implant by Professor Axel Laczkovics of the Kliniken Bergmannsheil, Bochum, Germany, on September 12, 1996. Currently the On-X valve is used in more than 282 centers in more than 37 countries worldwide.
Heart valves control the direction of blood flow in the heart.
Patients with diseased heart valves may suffer discomfort with exertion, fatigue and shortness of breath. If left untreated, heart valve disease can be life threatening. Surgical replacement of the damaged natural valve with an artificial valve, such as the On-X Prosthetic Heart Valve, is a common treatment for severe heart valve disease. Approximately 60 percent of all heart valve replacement implants are mechanical valves. However this percentage may change.