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Alliance for Anticoagulation Self-Monitoring

By HospiMedica staff writers
Posted on 17 Oct 2005
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A strategic alliance has been announced by Medical Carbon Research Institute LLC (MCRI, Austin, TX, USA), manufacturer of the On-X prosthetic heart valve, and Quality Assured Services (QAS, Orlando, FL, USA), a leading provider of anticoagulation products and services.

Under the alliance, QAS will promote the use of anticoagulation self-monitoring by recipients of the On-X valve by providing the ProTime system for patient self-monitoring and the feedback system that allows doctors to oversee treatment and data capture. The On-X valve is designed to provide patients with new alternatives in type and level of anticoagulation. The pure carbon material and innovative design of the valve are associated with reduced rates of valve-related complications, especially at low and fluctuating anticoagulation levels. The valve is currently sold in 69 countries around the world.

To minimize the risk of thrombotic events, mechanical heart valve patients take blood-thinning medications, but they must regularly monitor their anticoagulation levels, expressed as an international normalized ratio, or INR. Clinical studies have documented meaningful reductions in valve-associated complications through self-monitoring. A trial currently being conducted in Germany is using aspirin as the only anticoagulant. The preliminary conclusion, after three years, is that "select patients with an On-X valve in the aortic position can be safely maintained on 100 mg a day of aspirin,” according to Uwe Mehlhorn, M.D., University of Cologne, a participant in that study.

"Based on recent trials, the combination of device therapy and monitoring appear to provide significant clinical benefits to patients,” said Clyde Baker, president of MCRI. "The alliance allows us to offer the On-X heart valve, in combination with self-monitoring of INR, and potentially reduce patients' anticoagulation.”




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