FDA Grants Expanded Labeling Claim to On-X Aortic Heart Valve
The FDA has expanded a labeling claim for On-X Life Technologies’ aortic heart valve, allowing thousands of Americans to reduce their blood-thinning medication requirements, the Austin, Texas, devicemaker announced Thursday.
While all mechanical heart valve patients must take anticoagulants, FDA’s pronouncement makes the On-X the only one to allow patients to be managed three months following surgery at an International Normalized Ratio level of 1.5 to 2.0, which hews closer to an unmedicated INR. AHA-AHC guidelines generally recommend a target range of 2.0 to 3.0 INR, the time needed for a patient’s blood to clot, for mechanical heart valve patients.
High-risk On-X heart valve patients who reduced their blood-thinning medication to maintain a lower INR and who took a low-dose aspirin enjoyed a 65 percent overall reduction in bleeding episodes with no increased stroke rate, the Journal of Thoracic and Cardiovascular Surgery revealed in 2014.
On-X’s aortic valves had the lowest rate of clot formation when compared to eight other mechanical heart valves during a 50-year retrospective study, On-X Life Technologies founder Dr. Jack Bokros said.
The On-X aortic heart valve received FDA- and CE Mark-approval in 2001 and 1998, respectively, a company spokesperson told Device Daily Thursday. The FDA’s expanded labeling claim comes on the heels of a similar CE Mark expansion in 2014. — Jason Scott