LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it will present a summary of implantable neuromodulation technology for patients with heart failure during the 23rd Annual Scientific Meeting of the Heart Failure Society of America, September 13 – 16, Pennsylvania Convention Center, Philadelphia.
Autonomic Regulation Therapy (ART) is a novel neuromodulation approach to treating heart failure (HF), and the implantable LivaNova VITARIA® System delivers ART using Vagus Nerve Stimulation (VNS) to treat patients with chronic, symptomatic HF with reduced ejection fraction (HFrEF). The VITARIA System is currently being used to study the effects of ART in a prospective, international, randomized, controlled clinical trial (ANTHEM-HFrEF Pivotal Study). Dr. Inder S. Anand, FRCP, DPhil (Oxon), Professor of Medicine, University of Minnesota, Veteran Affairs Health Care System, Minneapolis and San Diego, and senior author of the ANTHEM-HF Pilot Study, will discuss ART during the “Clinical Trials for Emerging HF Drugs and Device Therapies (CVCT Joint Session)” from 8 to 9:30 a.m. EDT on Sunday, September 15, 2019.
“Automatic Regulation Therapy may be a breakthrough treatment option for patients with advanced, chronic heart failure, and we have applied the findings from previous ART research to the ANTHEM-HFrEF Pivotal Study. This therapy holds promise and is based on a contemporary understanding of the underlying neuroscience,” said Dr. Anand. “The more we evaluate the effects of this treatment for heart failure patients, the more we can learn about the disease and the potential ability of ART to transform patient lives.”
The VITARIA System received CE Mark approval in 2015 and is being evaluated under the U.S. Food and Drug Administration (FDA) approved investigation device exemption. The FDA has also granted the VITARIA System for Heart Failure Expedited Access Pathway approval as a potential breakthrough technology. If approved by the FDA, it could be the first in its class for treating chronic HF.
“Heart failure continues to be a large unmet need, and LivaNova is dedicated to advancing technology that has the potential to be a viable treatment for patients with the disease,” said Edward Andrle, LivaNova General Manager of Neuromodulation.
Additionally, two ART posters will be presented during the HFSA meeting. Posters are on display Saturday, September 14, with presenters available from 6:15 – 7:15 p.m. EDT in the poster area:
“Vagus Nerve Stimulation for Chronic Heart Failure: Differences in Therapy Delivery and Clinical Efficacy in ANTHEM-HF, INOVATE-HF, and NECTAR-HF”
“Long-Term Performance of Vagus Nerve Stimulation Lead: Low Rate of Complications and Failures”
To learn more about the LivaNova VITARIA System and the treatment of heart failure with ART, visit www.ARTforHeartFailure.com.
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.
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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.