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On-X® Prosthetic Heart Valve Receives Australian Approval
by
Anonymous
March 22, 2002 Medical Carbon Research Institute (MCRI), announced today that the Australian Therapeutic Goods Administration (TGA) has allowed the inclusion of the ON-X valve in the Australian Register of Therapeutic Goods (ARTG). With this registration, On-X valves are now available to patients in Australia and New Zealand. This approval closely follows the March 6, 2002, U.S. Food and Drug Administration (FDA) premarket approval (PMA) for the On-X® mitral valve.
On-X clinical trials, prerequisite for regulatory agency approval, began with the first implant on September 12, 1996. European Union CE mark approval was granted in 1998, and U.S. FDA premarket approvals were granted May 30, 2001, for the On-X aortic valve and March 6, 2002, for the On-X mitral valve.
The On-X valve utilizes pure On-X® 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 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.
MCRI, a privately-held company, was launched in 1994 by a consortium of heart valve designers, scientists and engineers. With more than 400 combined years of experience since the 1960’s, 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®'. We’re proud to have met the standards of the international regulatory agencies. 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.”
contact
Robert More
Vice President Research and Development
Medical Carbon Research Institute
8200 Cameron Road Ste A196
Austin, TX 78754
512 339 8000 ext 242
Toll free US and Canada 888 339 8000 ext 242
rmore@mcritx.com
This article courtesy of http://www.cylinder-hydraulic.com.
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