FDA GRANTS MCRI APPROVAL TO CONDUCT TRIAL OF HEART DEVICE
The FDA recently approved an investigational device exemption clinical trial for the Medical Carbon Research Institute's On-X Prosthetic Heart Valve at reduced anticoagulation levels.
Based on existing clinical data and the submitted protocol, the FDA has determined that a clinical trial of the On-X valve with three specific patient groups at reduced anticoagulation levels is clinically reasonable. The patient groups include low-risk aortic valve replacement patients, higher risk aortic valve replacement patients and mitral valve replacement patients. Higher risk patients include those with heart rhythm problems, left ventricular dysfunction, previous thrombo-embolism and condition of hypercoagulability.
Clinical centers and patients are now being recruited for the On-X reduced anticoagulation study. The study is limited to 1,200 patients and 20 institutions.
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.