UK medical technology firm LivaNova has secured CE mark for expanded use labeling with lower-dose blood thinners in low-risk patients.
Bicarbon aortic valves have been developed to be used in patients undergoing cardiac valve replacement. The valves feature Carbofilm coating technology that improves hemo and biocompatibility.
The expanded CE labeling allows to target lower international normalized ratio (INR) following Bicarbon aortic valve implantation in low-risk patients undergoing single bileaflet mechanical aortic valve replacement.
Physicians can use a lower-range level of anticoagulant therapy (INR range of 1.5 to 2.5 with 1.9 median target), after implanting LivaNova Bicarbon aortic heart valves in patients at low risk for thromboembolic events, helping to reduce the risk of bleeding with no increased risk of blood clots.
The approval was based on data from the Lowering-IT trial, in which patients witnessed a 60% reduction in risk of bleeding.
The study lead author Dr Michele Torella said: “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.”
LivaNova cardiac surgery business franchise general manager Alistair Simpson 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.”
Based in London, LivaNova carries out operation in around 100 countries across the globe with around 4,500 employees.
In December 2017, LivaNova agreed to purchase the remaining stake in US firm ImThera Medical for around $225m.
Based in San Diego of California, ImThera has developed a fully implanted neurostimulation device to treat obstructive sleep apnea (OSA).
Image: Bicarbon aortic valves were developed to be used patients undergoing cardiac valve replacement. Photo: courtesy of Somkiat Fakmee / FreeDigitalPhotos.net.