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LivaNova Aortic Valves Approved for Expanded Use Labeling
Devices Submissions and Approvals
LivaNova earned a CE Mark and approval for expanded use of its Bicarbon aortic valves with lower dose blood thinners in low-risk patients.
The expansion means that a lower international normalized ratio — the standard for measuring blood coagulability — can be targeted following implantation of the valve in low-risk patients going through mechanical aortic valve replacement.
After implanting the aortic heart valves in patients with low risk of thromboembolic events, physicians can work with a lower-range level of anticoagulant therapy, potentially reducing the risk of bleeding without the increased risk of blood clots.