AUSTIN, Texas, Aug. 23 /PRNewswire/ -- Medical Carbon Research Institute L.L.C. (MCRI(R)), manufacturer of the On-X(R) prosthetic heart valve, today announced the formation of a strategic alliance with Quality Assured Services, a leading provider of anticoagulation monitoring products and services, to promote the use of anticoagulation self monitoring by recipients of the On-X valve. QAS will provide the ProTime(R) system from ITC for patient self monitoring and the feedback system that allows physicians to oversee treatment and data capture.
A breakthrough in heart valve technology, the On-X valve may provide patients with new alternatives in type and level of anticoagulation. The pure carbon material and innovative design of the On-X valve are associated with reduced rates of valve-related complications -- especially at low and fluctuating anticoagulation levels.
"We are extremely pleased to form this alliance with QAS," said Clyde Baker, President of MCRI. "Based on recent trials, the combination of device, therapy and monitoring appear to provide significant clinical benefits for patients. The alliance allows us to offer the On-X heart valve, in combination with self monitoring of INR (under physician supervision) and potentially reduce patients' anticoagulation."
To minimize the risk of thrombotic events, mechanical heart valve patients take blood-thinning medication. As a result, they must regularly monitor their anticoagulation levels a measurement expressed by International Normalized Ratio or INR. Clinical studies have documented meaningful reductions in valve-associated complications through self-monitoring.
Clinical Trials in Progress
"Based on our preliminary review, it appears the implantation of the On-X valve, reduction of anticoagulation levels and patient self-monitoring of INR provide patients with the ideal combination of a durable valve procedure with a manageable lifestyle," said Vinay Badhwar, MD of Cardiac Surgical Associates (CSA), a multi-hospital cardiac surgery practice in the Tampa, Fla. area. "To date, we have not seen any valve or anticoagulation related adverse events in our trials. As our experience evolves, this data will be presented; until then, the benefit to patients appears very promising."
Another On-X valve trial is currently being conducted in Germany using aspirin as the only anticoagulant. In its third year, the preliminary conclusion from the study is that "select patients with an On-X valve in the aortic position can be safely maintained on 100 mg per day aspirin. These patients are being managed like patients receiving tissue valves in accordance with AHA/ACC guidelines). More patients and longer follow-up are required to draw statistically valid conclusions," according to Uwe Mehlhorn, MD of University of Cologne.
In South Africa 438 On-X valve patients have been followed (95%) for five years, the patients are documented to have varying amounts of anticoagulation. Approximately 14% of On-X patients were categorized as having "unsatisfactory" or anticoagulation below 1.5 INR and 29% had "no" or "unknown" anticoagulation, which was attributed to poor patient compliance to established protocols. It is remarkable that among Aortic, Mitral and Double Valve patients, only 1 (.2%) of the patients have experienced thrombosis.
Until the completion and analysis of study data, MCRI continues to recommend standard anticoagulation therapy as presently prescribed by various professional societies for the On-X valve.
"The opportunity to work together with MCRI valve recipients and their physicians to promote the use of self-monitoring of anticoagulation utilizes the core competency of QAS as the market leader in this area," said Michael R. Visnich, President and CEO of QAS. "Our experience and success with thousands of patients over the last, almost, nine years will help to ensure the success of this partnership."
"ProTime is the perfect monitoring system to complement the QAS service and help facilitate these important trials," said Larry Cohen, President of ITC.
About Cardiovascular Disease and Heart Valve Replacement
Cardiovascular disease is the number one cause of death worldwide. Heart Disease and Stroke Statistics-2002 Update, published by the American Heart Association, states that over 709,000 people undergo open-heart surgery each year, of which approximately 93,000 surgeries are to treat malfunctioning or diseased heart valves. According to a May 2004 report issued by Health Research International, it is estimated that approximately 85,000 Americans will receive heart valve replacements in 2005.
About MCRI
Medical Carbon Research Institute (MCRI(R)) 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(R) aortic valve in 2001, approval on the On-X mitral valve in 2002, has gained approval to market in Japan in 2005 and is presently sold in 69 countries around the world. MCRI also provides OEM services utilizing its patented pyrolytic carbon to manufacturers of other medical products including orthopedic joint and spine implant devices. MCRI is headquartered in Austin, Texas. More information is located at www.onxvalves.com or www.mcritx.com or by contacting Clyde Baker at 512-339-8000 or at cbaker@mcritx.com.
About QAS
QAS was incorporated in March of 1997 to coincide with the first FDA cleared product for patient self-testing of INR, the ProTime Microcoagulation System. QAS now supplies all available brands of FDA cleared INR monitors. Along with an anticoagulation monitoring service, these products and disposables have been supplied to many thousands of individuals and clinics all across the United States. QAS improves the medical and economic outcome for Healthcare Professionals and Patient/Consumers alike who must monitor potentially life-threatening conditions. Leveraging its respected Brand, QAS focuses on the positive experience of the end user, winning life long customers. QAS has grown significantly for eight consecutive years and has been recognized by Inc. Magazine as one of the fastest growing private companies in America for three years in a row. For further information see www.ptinr.com or contact Michael Fine at 1-800-298-4515 or mfine@qasmail.com.
About ITC
ITC is a wholly-owned subsidiary of Thoratec and develops, manufactures and markets medical devices used in three distinct segments of the medical field. The HEMOCHRON(R) product line provides point-of-care coagulation monitoring in operating rooms and cardiac catheterization labs. The HEMOCHRON and ProTime(R) microcoagulation system product lines monitor the effect of oral anticoagulation with simple-to-use instruments for point of care, professionals, and patient self-testing use. The Hgb Pro system is a hand-held, battery-powered meter for measuring total hemoglobin. ITC is also the technology leader in precision, automated skin-incision technology and manufactures the Tenderlett(R), Tenderfoot(R) and Surgicutt(R) products for fingerstick, infant heel incision and bleeding-time measurements. In 2003, ITC expanded its product line by acquiring IRMA TRUpointTM, a point-of-care diagnostic system for intermittent blood gas monitoring performed in the operating room or at the bedside.
NOTE: MCRI and On-X are registered trademarks of Medical Carbon Research Institute L.L.C. All other trademarks mentioned herein belong to their respective companies.
Medical Carbon Research Institute L.L.C.CONTACT: Karen Siuda of Blanc & Otus, +1-512-372-6654, orksiuda@blancandotus.com, for Medical Carbon Research Institute L.L.C.; orMichael Fine of QAS, +1-800-298-4515, or mfine@qasmail.com
Web site: http://www.mcritx.com/
