MCRI plans to market the On-X Heart Valve in the European Union through a network of independent distributors. To date, approximately 300 patients have received On-X valve implants with excellent results. Under U.S. and European regulations, the On-X valve clinical trials are monitored by an independent advisory board that consists of expert cardiovascular surgeons and cardiologists. Clinical trial results are evaluated in a scientific peer review forum. In the clinical trials, surgeons replace diseased heart valves with the On-X Valve.
Heart valves are one-way valves that control the direction of blood flow in the heart.
Patients with diseased heart valves suffer discomfort with exertion, fatigue and shortness of breath. If left untreated, heart valve disease can be life threatening. However, On-X Carbon represents the first significant advance in biomedical pyrolytic carbon quality in more than 20 years of utilization. On-X Valve design enhancements include a shaped and lengthened orifice that reduces pressure losses, turbulence and shear stresses. Factors that contribute to valve noise, mechanical stresses and cavitation potential are minimized by utilizing an optimum geometric orifice area.