On-X aortic and mitral valves are FDA approved.
CAUTION: Federal law restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use that accompany each valve for indications, contraindications, warnings, precautions and possible complications.
CAUTION: Investigational use of this device in the Prospective Randomized On-X Valve Anticoagulation Trial (PROACT) is limited by federal law to investigational sites.
CAUTION: Until the completion and analysis of PROACT study data, On-X Life Technologies, Inc., continues to recommend standard anticoagulation therapy as presently prescribed by various professional societies for the On-X valve.1
1. ACC/ AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the1998 Guidelines for the Management of Patients With Valvular Heart Disease): Developed in Collaboration With the Society of Cardiovascular Anesthesiologists Endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons Circulation 2006;114;84-231. DOI: 10.1161/CIRCULATIONAHA.106.176857