LivaNova to Present Autonomic Regulation Therapy Findings for Heart Failure During European Society of Cardiology Congress 2020

In a novel therapeutic approach, the LivaNova VITARIA^® System delivers ART via mild electrical impulses applied to the right vagus nerve to increase parasympathetic activity in ways that improve regulation of cardiovascular function, including electrophysiological stability, in patients with advanced heart failure. The ANTHEM-HF clinical study (NCT01823887) reported improved baroreceptor sensitivity (heart rate turbulence or HRT), heart rate variability (rMSSD) and reduced cardiac electrical instability (T-wave alternans or TWA) after 12 months of chronic vagus nerve stimulation. However, it remained unknown whether these benefits persist beyond one year.

“With more than 25 million people worldwide suffering from heart failure, it is crucial that we find improved methods to treat this complex syndrome,” said Bruce H. KenKnight, PhD and LivaNova Vice President of the Heart Failure Program. “In the ANTHEM-HF study, we evaluated HRT, rMSSD and TWA at six, 12, 24 and 36 months to assess the durability of therapeutic effects. We look forward to sharing the long-term results during ESC 2020.”

In lieu of traditional in-person presentations, ESC will publish all e-posters accepted for presentation on Friday, Aug. 28 at 7:30 a.m. London time. The following LivaNova poster will be shared:

“Multi-Year Improvement in Autonomic Tone, Baroreceptor Sensitivity and Cardiac Electrical Stability Using Vagus Nerve Stimulation in Patients with HFrEF in the ANTHEM-HF Study”
Bruce D. Nearing, PhD, Inder S. Anand, MD, Imad Libbus, PhD, Lorenzo A. DiCarlo, MD, Bruce H. KenKnight, PhD and Richard L. Verrier, PhD, FACC

The VITARIA System received CE Mark approval in 2015 and has been approved by the U.S. Food and Drug Administration (FDA) to participate in the Breakthrough Technology Program. If approved by the FDA, it could be the first in its class for treating chronic heart failure. VITARIA is currently being used to study the effects of ART in a prospective, international, randomized, controlled clinical trial, the ANTHEM-HFrEF Pivotal Study (NCT03425422).

To learn more about the LivaNova VITARIA System and the treatment of heart failure with ART, visit www.ARTforHeartFailure.com.

About LivaNova

LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 4,000 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), respectively.

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

Safe Harbor Statement

This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding ART and our approach to treating heart failure by delivering ART using vagus nerve stimulation. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, as supplemented by any risk factors contained in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.