LivaNova PLC (LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, has received CE Mark approval for its Bicarbon® aortic valves for use with low-dose anticoagulant therapy. The expanded CE labeling means that a lower international normalized ratio (INR), the standardized index used to measure blood coagulability, can be targeted following Bicarbon aortic valve implantation in low-risk1 patients undergoing single bileaflet mechanical aortic valve replacement.
“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.”
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.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe LivaNova’s future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," “could,” “seek,” “guidance,” “predict,” “potential,” “likely,” "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this news release are based on information presently available to LivaNova and assumptions that LivaNova believes to be reasonable, but are inherently uncertain. As a result, LivaNova’s actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance or actions that may be taken by LivaNova and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond LivaNova’s control.
All information in this news release is as of the date of its release. LivaNova does not undertake or assume any obligation to update publicly any of the forward-looking statements in this news release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this news release.
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