LivaNova (NSDQ:LIVN) said today it won expanded CE Mark labeling for its Bicarbon aortic heart valves, now cleared for use with low-dose anticoagulant therapy.
The new approval clears low risk patients who’ve received a Bicarbon aortic valve implant to be targeted using a lower international normalized ratio measurement of blood coagulability, allowing for a lower-range level of anticoagulant medication therapy, the London-based company said.
“When choosing a mechanical valve, patients look for a treatment option which lasts for life. The lower INR range approval for LivaNova Bicarbon Aortic Valves means patients now have a greater choice when selecting a mechanical prosthesis, with the freedom to enjoy a more active, confident lifestyle,” LivaNova cardiac surgery biz GM Alistair Simpson said in a press release.
The expanded indication was supported by results from the company’s Lowering-IT trial of the valve, which reported that patients experienced a 60% reduction in risk of bleeding.
“Our experience from the Lowering-IT trial with nearly 300 patients implanted with Bicarbon aortic valves maintained with an INR close to 1.9, with a median follow-up of over five years was presented at the American Heart Association 2017 meeting in Anaheim, California. Our study indicated that the proposed low-INR range between 1.5 and 2.5 (with 1.9 median target) is safe and feasible in low-risk patients after isolated aortic valve replacement with LivaNova’s Bicarbon prosthesis, resulting in similar thrombotic events and in a significant reduction of bleeding occurrence when compared to the conventional anticoagulation regimen,” study lead author Dr. Michele Torella of Naples, Italy’s Monaldi Hospital said in a prepared statement.
Yesterday, LivaNova said it launched a new feasibility trial of its Microburst Vagus Nerve Stimulation therapy system exploring its safety and effectiveness in treating patients with drug-resistant epilepsy.
