The FDA expanded the labeling for a mechanical aortic valve by approving a lower International Normalized Ratio (INR) that is closer to an unmedicated range.
The FDA’s decision allows some patients implanted with On-X Aortic Heart Valves to reduce their anticoagulation therapy, which also may lower their risk of bleeding. Guidelines generally recommend patients treated with a mechanical valve maintain an INR of 2 to 3. The label change allows for an INR of 1.5 to 2 beginning three months after the implant.
The label expansion applies only to On-X mechanical aortic valves, which are made by Austin, Texas-based On-X Life Technologies.