LivaNova to Present Autonomic Regulation Therapy Findings for Heart Failure During European Society of Cardiology Congress 2019

Autonomic Regulation Therapy (ART) is a novel approach to treating heart failure, and the LivaNova VITARIA^® System delivers ART using Vagus Nerve Stimulation (VNS) in patients who experience symptoms of heart failure despite receiving guideline-directed medical therapy. VITARIA is currently being used to study the effects of ART in a prospective, international, randomized, controlled clinical trial (ANTHEM-HFrEF Pivotal Study).

“At LivaNova, we’re advancing therapies that have meaningful impact, and the ANTHEM-HFrEF study is evaluating how our VITARIA System could improve care for patients with chronic heart failure,” said Edward Andrle, LivaNova General Manager of Neuromodulation. “We are encouraged by the results from our pilot study and the potential impact of this therapeutic innovation.”

The VITARIA System received CE Mark approval in 2015 and has been granted Expedited Access Pathway as a breakthrough technology by the U.S. Food and Drug Administration (FDA). If approved by FDA, it could be the first in its class for treating chronic heart failure.

“Despite major advances, chronic heart failure is a growing challenge, and this breakthrough study may reveal a potentially life-transforming alternative to the current treatment landscape,” said Dr. Marvin Konstam, Chief Investigator of the ANTHEM-HFrEF Pivotal Study and Chief Physician Executive of the CardioVascular Center at Tufts Medical Center in Boston. “Chronic heart failure often leads to continued deterioration in patients despite using guideline-directed medical therapy. Patients and clinicians need new therapeutic approaches to treat this critical disease condition.”

Two posters, one comparing the clinical efficacy associated with different VNS technology platforms and delivery methods, and one reporting the long-term performance of the LivaNova VNS lead, will be presented during the Scientific and Education Sessions of ESC Congress 2019 on Monday, September 2 and Tuesday, September 3.

Posters are on display from 8:30 a.m. – 12:30 p.m. with presenters available from 10:05 – 10:55 a.m. GMT in the poster area:

Monday, September 2: “Vagus Nerve Stimulation for Chronic Heart Failure: Differences in Therapy Delivery and Clinical Efficacy in ANTHEM-HF, INOVATE-HF, and NECTAR-HF”
Inder Anand MD, DPhil (Oxon), Marvin A. Konstam MD, James E. Udelson MD, Javed Butler MD, Helmut U. Klein MD, John D. Parker MD, and John R. Teerlink MD, Imad Libbus PhD, Badri Amurthur MS, MBA, Bruce H. KenKnight PhD, Jeffrey L. Ardell PhD, Douglas D. Gregory PhD, Joseph M. Massaro PhD, and Lorenzo A. DiCarlo MD

Tuesday, September 3: “Long-term Performance of Vagus Nerve Stimulation Lead: Low Rate of Complications and Failures”
Imad Libbus PhD, Scott R. Stubbs, Scott Mindrebo, Bruce H. KenKnight PhD, Lorenzo A. DiCarlo MD

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 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 approximately 4,000 employees. 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 press 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 VNS. 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, 2018, 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.

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