AUSTIN, Texas, Feb. 22 /PRNewswire/ -- Medical Carbon Research Institute L.L.C. (MCRI), today announced the approval of the On-X Prosthetic Heart Valve by the Japanese Ministry of Health, Labor and Welfare (MHLW). Japan is the second largest market in the world for mechanical valves. The On-X valve introduction will begin on February 23, during the 35th Annual Meeting of the Japanese Society for Cardiovascular Surgery in Hamamatsu, Japan. The introduction represents a joint effort by MCRI and Paramedic Co., LTD. of Tokyo, who will provide exclusive representation for the On-X valve throughout Japan. Approval by MHLW was achieved through collaboration between regulatory departments of MCRI and Paramedic and was based on clinical trials conducted in the U.S. and Europe, the first valve approval to be granted in Japan based entirely on overseas clinical data.
"It is difficult to overstate the importance of this regulatory approval to MCRI. The opening of this major new market for the On-X valve represents a significant revenue opportunity for our company. In combination with the 60% growth experienced in On-X valve sales in 2004, the approval will provide MCRI with an opportunity for continued growth of world wide market share for this advanced prosthesis," stated Clyde Baker, President of MCRI. "We are gratified by the rapid acceptance of the On-X valve by leading institutions in the United States and believe that Japanese surgeons will be particularly interested in technical differences of the On-X valve and will desire that their patients benefit from reduced valve related complications and improved hemodynamic performance documented with the use of the On-X valve."
The On-X valve is the product of a technology break-through in carbon materials manufacturing and heart valve design. These technologies provide a 100% pure carbon surface and help create a turbulent free blood flow through the valve. The result is a valve with morbid event occurrence so reduced as to justify a study with selected aortic valve replacement patients using one aspirin a day as the only anticoagulation. This study has just passed the one-year anniversary of its initiation, a milestone untouched by competitive mechanical valves.
About Cardiovascular Disease and Heart Valve Replacement
Cardiovascular disease is the number one cause of death worldwide. Heart Disease and Stroke Statistics-2005 Update, published by the American Heart Association, states that over 700,000 people undergo open-heart surgery each year, of which approximately 93,000 surgeries are to treat malfunctioning or diseased heart valves.
Medical Carbon Research Institute (MCRI) develops heart valve replacements that significantly improve the quality of life of patients. Jack Bokros, Ph.D., and his associates founded MCRI in 1994 to further advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The company gained FDA approval for the On-X aortic valve in 2001 and for the On-X mitral valve in 2002.
MCRI also provides OEM services to other medical products companies utilizing its patented pyrolytic carbon for use as orthopedic joint and spine prosthetic implants.
MCRI is headquartered in Austin, Texas, and maintains a wholly owned subsidiary, MCRI Deutschland GmbH, in Hannover, Germany. MCRI is a privately held company whose operations have to date been funded through equity and debt investments by its founders, strategic investors and a capital fund. More information is located at http://www.mcritx.com/ or at http://www.onxvalves.com/ .
For more information about MCRI or the On-X Prosthetic Heart Valve please contact Clyde Baker, President at 512-339-8000 ext. 269 or at firstname.lastname@example.org .
In Japan please contact Paramedic Co. Ltd (Tel) 03-3582-2222 or email@example.com.
MCRI and On-X are registered trademarks of Medical Carbon Research Institute L.L.C.
Contact: Clyde Baker
512-339-8000, ext. 269
Medical Carbon Research Institute L.L.C.