MCRI Gets Go-Ahead To Study Reduced Anticoagulation Therapy With Valves
This article was originally published in The Gray Sheet
Executive Summary
The Medical Carbon Research Institute has received the first investigational device exemption from FDA to study whether a mechanical heart valve can be indicated for use with reduced levels of anticoagulants
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On-X trial begins
Medical Carbon Research Institute initiates 1,200 patient, 20-center PROACT (Prospective Randomized On-X Prosthetic Heart Valve Anticoagulation Clinical Trial) study to support a PMA supplement for use of its On-X heart valve with reduced levels of anticoagulants, announced Aug. 22. If approved, the heart valve would become the first to be labeled for use with lower doses of drugs (1"The Gray Sheet" Jan. 16, 2006, p. 7). The investigation is expected to take five years...
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