Autonomic Regulation Therapy for Heart Failure Pivotal Study

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Autonomic Regulation Therapy for Heart Failure Pivotal Study

A new minimally invasive investigational treatment for patients with heart failure

LivaNova, recently announced the first successful implantation of the VITARIA® System in a patient enrolled in the Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure With Reduced Ejection Fraction (ANTHEM-HFrEF) Pivotal Study. 

The UnityPoint Health Cedar Rapids Heart & Vascular Institute was the first site activated by the Study. The first two implants in the study were completed at St. Luke’s Hospital by Dr. Jared Kray. The study is an international, multi-center, randomized trial to evaluate the VITARIA System for the treatment of advanced heart failure. 

“Patients with advanced heart failure continue to need additional and complementary therapy options, since drug treatment alone has slowed but not stopped heart failure progression,” said Dr. Ron M. Oren, Heart Failure Cardiologist and Lead Investigator for the Study at UnityPoint Health - Cedar Rapids Heart and Vascular Institute. “We are pleased to participate in this important study to critically evaluate the safety and efficacy of Autonomic Regulation Therapy delivered by the VITARIA System.”

The LivaNova VITARIA System delivers Autonomic Regulation Therapy (ART) using Vagus Nerve Stimulation (VNS) in patients who continue to experience symptoms of heart failure despite receiving guideline-directed medical therapy. 

“There haven’t been many new developments in heart failure treatment in recent years. The addition of this device to our current treatments could be a game-changer in helping patients feel better and be hospitalized less, says Clinical Research Coordinator Amy Schweer, “It’s exciting to be involved in such an important international study. UnityPoint Health Heart and Vascular Institute was the first study site to be activated, enrolled the first subject, randomized the first subject and implanted the device in the first two subjects.”

Do you have Heart Failure?

If your doctor has told you that you have heart failure you have come to the right place. Medications alone are often not enough for patients suffering from heart failure. Additionally, some patients may not be good candidates for more invasive procedures. If you’re one of these patients, you may qualify for a clinical trial studying an investigational device for heart failure. Read more to determine if you are eligible for the study.

About the VITARIA SYSTEM

The VITARIA System received CE Mark approval in 2015 and received Expedited Access Pathway designation as a breakthrough technology from the U.S. Food and Drug Administration in 2017. The therapy may be the first implantable active neurostimulation system for the treatment of advanced heart failure, if the study demonstrates statistically and clinically meaningful improvements in pre-specified endpoints related to heart failure symptom improvement, hospitalization and survival.

“LivaNova is dedicated to changing lives through the development and introduction of novel technologies, which address large unmet needs in the global medical community. Autonomic Regulation Therapy is based on our market-leading experience derived from VNS Therapy®, which is used to treat other disorders,” said Edward Andrle, LivaNova General Manager of Neuromodulation. “The ANTHEM-HFrEF Pivotal Study brings us closer to offering the VITARIA System to a large segment of the more than 20 million people currently battling heart failure around the world."