LivaNova to Present Autonomic Regulation Therapy Findings for Chronic Heart Failure Patients at the American College of Cardiology 68th Annual Scientific SessionThe Associated Press
LONDON--(BUSINESS WIRE)--Mar 15, 2019--LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced it will present three abstracts supporting the use of implantable neuromodulation technology to treat chronic heart failure during the American College of Cardiology 68th Annual Scientific Session (ACC 2019) from March 16-18 in New Orleans, USA.
The LivaNova VITARIA ® System delivers Autonomic Regulation Therapy (ART) using Vagus Nerve Stimulation (VNS) to treat patients with chronic, symptomatic heart failure with reduced ejection fraction (HFrEF). VITARIA is currently being used to study the effects of ART in a prospective, international, randomized, controlled clinical trial (ANTHEM-HFrEF Pivotal Study). Patients meeting all inclusion and exclusion criteria are randomized (2:1) to either the treatment arm or the control arm, and are followed thereafter to determine the safety and efficacy of the system and therapy.
“LivaNova is dedicated to changing lives through development and commercial introduction of innovative solutions, like the VITARIA System, which is the first system to deliver therapeutic levels of Autonomic Regulation Therapy through Vagus Nerve Stimulation,” said Edward S. Andrle, LivaNova’s General Manager of Neuromodulation. “Patients with chronic heart failure continue to deteriorate despite best medical therapy; the unmet need is large and growing.”
The VITARIA System has received Expedited Access Pathway designation as a Breakthrough Technology from the U.S. Food and Drug Administration. If approved, the VITARIA System could be the first in its class for treating chronic heart failure.
“The results from this landmark study have the potential to fundamentally alter the paradigm of treating chronic heart failure,” 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. “The therapeutic effects of ART appeared to work synergistically with guideline-directed medical therapy in the ANTHEM-HF Pilot Study. We look forward to seeing the safety and efficacy results of the pivotal study.”
Three posters related to long-term follow-up and dosing of ART in the ANTHEM-HF Pilot Study will be presented during Scientific Sessions of ACC 2019 on Saturday, March 16 from 1:30-4:30 p.m. Central Time in the poster area:
“Long-term Follow-up of Reduced Ejection Fraction Heart Failure Patients Receiving Autonomic Regulation Therapy in the ANTHEM-HF Pilot Study”
Rajendra K. Premchand, MD; Kamal Sharma, MD; Sanjay Mittal, MD; Rufino Monteiro, MD; Imad Libbus, PhD; Lorenzo DiCarlo, MD; Jeffrey L. Ardell, PhD; Badri Amurthur, MS; Bruce H. KenKnight, PhD; Inder S. Anand, MD, FRCP, DPhil
“Comparison of Background Pharmacologic Therapy in the ANTHEM-HF Pilot Study to Contemporary Trials of Novel Heart Failure Therapies”
Rajendra K. Premchand, MD; Kamal Sharma, MD; Sanjay Mittal, MD; Rufino Monteiro, MD; Imad Libbus, PhD; Jeffrey L. Ardell, PhD; Bruce H. KenKnight, PhD; Badri Amurthur, MS; Lorenzo DiCarlo, MD; Inder S. Anand, MD, FRCP, DPhil
“Quantitative Assessment of Transient Heart Rate Dynamics in Patients Exposed to Chronic Autonomic Regulation Therapy Provides Evidence of Durable Neuromodulation Resulting from Cyclic Stimulation of the Vagus Nerve”
Imad Libbus, PhD; Scott T. Mazar; Badri Amurthur, MS; Lorenzo A. DiCarlo, MD; Bruce H. KenKnight, PhD
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 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 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. You should carefully consider the risks and uncertainties that affect LivaNova, including those described in the “Risk Factors” section of LivaNova’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the United States Securities and Exchange Commission.
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.
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CONTACT: LivaNova PLC
Deanna Wilke,+1 (281) 727-2764
Director, Corporate Communications
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PUB: 03/15/2019 09:00 AM/DISC: 03/15/2019 09:01 AM