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 Alistair Simpson, General Manager of LivaNova’s Cardiac Surgery business franchise.

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 American Heart Association 2017 meeting in Anaheim, California,” said study lead author Michele Torella, M.D., Ph.D., Department of Cardio-Thoracic and Respiratory Sciences, Monaldi Hospital, Second University of Naples, Naples, Italy. “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.”

About LivaNova

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 (Italy), Houston (U.S.A.) and Clamart (France), respectively.

For more information, please visit www.LivaNova.com.

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1. INR range 1.5-2.5 in patients at low risk for thromboembolic events undergoing single mechanical aortic valve replacement
2. Single center experience with the Sorin Bicarbon prosthesis: A 17-year clinical follow-up. Celiento et al. – J Thorac Cardiovasc Surg 2014;148:2039-44
3. LOWERing the intensity of oral anticoagulant Therapy in patients with bileaflet mechanical aortic valve replacement: Results from the “LOWERING-IT” Trial. Torella et al. – Am Heart J 2010;160:171-8