LONDON--(BUSINESS WIRE)--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.
About LivaNova
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.
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