Medical Carbon Research Institute receives FDA approval for prosthetic heart valve
Medical Carbon Research Institute (MCRI), announced today that the U.S. Food and Drug Administration (FDA) has issued a premarket approval (PMA) for the On-X aortic valve. With the PMA, the On-X aortic valve is now available in the United States as a replacement for diseased heart valves.
The On-X valve utilizes pure On-X pyrolytic carbon in an optimized hemodynamic bileaflet design. In addition to the pure pyrolytic carbon, unique design features include a near natural length, inlet flare, full opening leaflets, optimum orifice and supra-annular positioning. Evaluation of the On-X valve design included state of the art mechanical testing, structural analyses and extensive clinical testing in Europe and North America. The clinical experience beginning with the first implant in 1996 has demonstrated the safety and effectiveness of the On-X valve.
"The On-X valve has remarkable clinical performance," said John Ely, MCRI Vice President of Clinical and Regulatory Affairs. "The On-X valve sets 'The New Standard(TM)': the hemodynamics are superior and the smooth blood flow results in minimal blood damage and low complication rates, which provide maximal benefit and restored quality of life for patients. 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. European Union CE mark approval and FDA investigational device exemption (IDE) approval for implants in the United States were granted in 1998. 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.
There are more than 200,000 heart valve replacements per year in the $600 million worldwide market with about 70,000 replacements occurring in the United States. Approximately 60 percent of all heart valve replacement implants are mechanical valves. However this percentage may change. Roger Thomas, MCRI Vice President of Sales observes "On-X valve performance actually rivals that of stentless and autologous biological valves and may well provide a more durable and lasting valve replacement for an aging population with today's longer expected life durations."
MCRI, a privately held company, was launched in 1994 by a consortium of heart valve designers, scientists and biomedical engineers. With more than 400 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, "The On-X valve design and On-X carbon are the products of the new ideas, innovations and insights gained from this 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(TM).' We're proud to have met the standards of the U.S. FDA. It's a tribute not just to our product but also to the careful work of the physicians around the world who have participated in our clinical trials. 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."
Source: Medical Carbon Research Institute (MCRI)
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