Medical Carbon Research Institute Release: FDA Approved Non-Warfarin And Reduced Warfarin Anticoagulation Trial Of The On-X Prosthetic Heart Valve Initiated At Emory Crawford Long Hospital
8/22/2006 11:29:48 AM
AUSTIN, Texas--(BUSINESS WIRE)--Aug. 22, 2006--
Medical Carbon Research Institute L.L.C. (MCRI(TM)) today announced initiation of the FDA approved clinical trial PROACT (Prospective Randomized On-X(R) Prosthetic Heart Valve Anticoagulation Clinical Trial) being conducted under an investigational device exemption (IDE) at reduced anticoagulation levels at Emory Crawford Long Hospital, Emory University in Atlanta, Georgia. The study began with the approval of the Crawford Long and Emory University Institutional Review Board and the first implantation of the On-X valve under the approved protocol and is also being conducted at 19 other prestigious institutions throughout the US. Successful completion of the clinical study could result in the On-X valve becoming the only mechanical heart valve approved for low-dose anticoagulation therapy.