First successful implantation of the Vitaria System in a patient in the ANTHEM-HFrEF pivotal study to reduce progression of heart failure.- LivaNova

LivaNova PLC announced the 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 study is an international, multi-center, randomized trial to evaluate the Vitaria System for the treatment of advanced heart failure. The first implant in the pivotal study was completed at UnityPoint Health � St. Luke�s Hospital in Cedar Rapids, Iowa, by Dr. Jared Kray. �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 the Heart and Vascular Institute in Cedar Rapids, Iowa. �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. 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.