To date, approximately 400 patients have received On-X Heart Valve implants with excellent results. The notified body, T V Product Service, Munich, issued the CE Mark authorization following a thorough critical review of MCRI's analyses and clinical results. MCRI is conducting a similar clinical study in the United States under FDA Investigation Device Exemption regulations that began in March 1998. The U.S. study is expected to be complete by the fourth quarter of 1999. On-X Heart Valve design enhancements include a shaped and lengthened orifice that reduces pressure losses, turbulence and shear stresses.
Heart valves are one-way valves that 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 Heart Valve, is a common treatment for severe heart valve disease. Clinical hemodynamic results demonstrate significant improvements in On-X Heart Valve performance relative to other bileaflet designs. Improved performance enhances patient quality of life.