MCRI Announces First U.S. On-X Valve Implant
Medical Carbon Research Institute, LLC (MCRI) announced that a surgical team led by Dr. Tom Ivey at Christ Hospital in Cincinnati, Ohio has successfully completed the first surgical replacement of a diseased aortic valve with the new high performance On-X Valve in the United States.
This surgery initiates the U.S. clinical study of the On-X Valve under Food and Drug Administration (FDA) sanctioned Investigational Device Exemption (IDE) regulations. This clinical trial is a critical step in the process of obtaining FDA approval for marketing the On-X valve in the U.S.
European clinical trials, under local regulations, of the On-X valve have been ongoing for more than a year. To date, approximately 305 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.
The On-X Valve is a bileaflet mechanical valve manufactured from On-X Carbon, an ultra-pure, unalloyed pyrolytic carbon. Silicon-alloyed pyrolytic carbons are used in other bileaflet mechanical valve designs such as those manufactured by Sulzer CarboMedics, Austin, TX and St. Jude Medical, Minn. MN.
However, On-X Carbon represents the first significant advance in biomedical pyrolytic carbon quality in more than 20 years of utilization. The On-X Carbon material improvements: increased purity, strength, toughness and superior production control provides design opportunities, unavailable with other pyrolytic carbon, that are exploited to advantage in the On-X Valve design.
On-X Valve design enhancements include a shaped and lengthened orifice that reduces pressure losses, turbulence and shear stresses. Flow area is maximized by supra-annular positioning and by the increased On-X Carbon strength, which minimizes wall thickness and stiffening ring bulk. Factors that contribute to valve noise, mechanical stresses and cavitation potential are minimized by utilizing an optimum geometric orifice area.
Clinical hemodynamic results demonstrate significant improvements in On-X Valve performance relative to other bileaflet designs. Such improved performance enhances patient quality of life. Enhanced quality of life through utilization of advanced materials technology and advanced design concepts provides the competitive edge for the On-X Valve in today's $600 million dollars per year worldwide heart valve market.