FDA Issues Premarket Approval for On-X Prosthetic Heart Valve.

Business Editors & Health/Medical Writers

AUSTIN, Texas--(BW HealthWire)--March 7, 2002

Approval Granted to Medical Carbon

Research Institute, LLC. for Mitral Prosthetic Heart Valve, Recent

Winner of Medical Design Excellence Award

Medical Carbon Research Institute (MCRI(TM)), announced today that the U.S. Food and Drug Administration (FDA) has issued a Premarket Approval (PMA) for the On-X(R) mitral valve. With this approval, the On-X aortic and mitral valves are now available in the United States.

The On-X valve utilizes pure On-X(R) pyrolytic carbon for an optimized bileaflet design, which was recently declared an award winner of the 2002 Medical Design Excellence Award competition in the Implant and Tissue-Replacement Products category. Prize winning design features include; a near natural length; a hemodynamic curved inlet; full opening leaflets; optimum orifice size; supra-annular, atrialized insertion and guards to protect the valve mechanism from retained mitral sub-valvular apparatus.

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.

On-X clinical trials, prerequisite for FDA approval, began with the first implant by Professor Axel Laczkovics of the Kliniken Bergmannsheil, Bochum, Germany, on September 12, 1996. European Union CE mark approval was granted in 1998 and FDA premarket approval for the On-X aortic valve in the United States was granted May 30, 2001.

Dr. Emory Dilling, an Austin cardiovascular surgeon, remarked, "The On-X valve is a better choice because I expect its design and smoother blood contacting surfaces to result in lower mitral valve thrombosis and thromboembolic complication rates than for other mechanical valves." Indeed, the On-X mitral valve demonstrates remarkable clinical performance. John Ely, MCRI Vice-President of Clinical and Regulatory Affairs said, "Clinical trials show superior hemodynamics. The smooth blood flow, minimal blood damage and low complication rates, especially for the mitral valve, provide maximal benefit and restored quality of life for patients."

MCRI, a privately held company, was launched in 1994 by a consortium of heart valve designers, scientists and biomedical engineers. With more than 500 combined years of experience since the 1960s, its principals have made components for more than 90 percent of the mechanical heart valves implanted in patients and have participated in all of the major innovations to date.

MCRI CEO Jack Bokros added, "On-X valve design and On-X carbon are the products of the new ideas, innovations and insights gained from our extensive experience. Our focus in designing the On-X valve was to mimic the contours and performance of the natural valve as closely as possible. We call it Natural By Design(R). We're proud to have met the standards of the U.S. FDA. Because the On-X valve out performs all other mechanical valves we expect to see it recognized as the treatment of choice for patients needing mechanical valve replacement."