On-X trial begins
This article was originally published in The Gray Sheet
Executive Summary
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...