|LivaNova Bicarbon Aortic Valves Receive CE Mark for Expanded Use Labeling with Lower-Dose Blood Thinners in Low-Risk Patients|
“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,” said
Patients with mechanical heart valves are at risk of blood clot formation (thrombosis and embolism). These patients are placed on lifelong anticoagulant therapy, which can cause side effects, including an increased bleeding risk. After implanting LivaNova Bicarbon aortic heart valves in patients at low risk for thromboembolic events, physicians can now work with a lower-range level of anticoagulant therapy (INR range of 1.5 to 2.5 with 1.9 median target), potentially reducing the risk of bleeding with no increased risk of blood clots.
In more than 25 years of clinical use and up to 17 years of published follow-up2, the Bicarbon family of mechanical valves has shown evidence of a very low incidence of thrombogenicity.
The expanded indication for the Company’s Bicarbon family of aortic heart valves is based on this evidence and the results from the LOWERING-IT trial where patients saw a 60 percent reduction in risk of bleeding3.
“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
LivaNova PLC is a global medical technology company built on nearly five
decades of experience and a relentless commitment to improve the lives
of patients around the world. LivaNova’s advanced technologies and
breakthrough treatments provide meaningful solutions for the benefit of
patients, healthcare professionals and healthcare systems. Headquartered
in London, LivaNova has a presence in more than 100 countries worldwide.
The Company currently employs more than 4,500 employees, inclusive of
approximately 900 employed by our CRM business franchise.
LivaNova operates as three business franchises: Cardiac Surgery,
Neuromodulation and Cardiac Rhythm Management, with operating
headquarters in Mirandola (
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1. INR range 1.5-2.5 in patients at low risk for
thromboembolic events undergoing single mechanical aortic valve
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