Medical technology firm LivaNova has launched the international pivotal study assessing the use of autonomic regulation therapy for heart failure.
The company has implanted the Vitaria system in a patient recruited in the autonomic regulation therapy to enhance myocardial function and reduce progression of heart failure with reduced ejection fraction (ANTHEM-HFrEF) pivotal study.
The first implant in an international, multi-center and randomized study has been completed at UnityPoint Health – St. Luke’s Hospital in Cedar Rapids, of Iowa, under the guidance of Dr Jared Kray.
Vitaria system provides autonomic regulation therapy (ART) with the support of vagus nerve stimulation (VNS) in patients who continue to experience symptoms of heart failure even though securing guideline-directed medical therapy.
The system secured CE mark approval in 2015, and also received expedited access pathway designation as a breakthrough technology from the US Food and Drug Administration (FDA) in 2017.
The therapy is expected to be the first implantable active neurostimulation system for the treatment of advanced heart failure, if the study shows statistically and clinically meaningful improvements in pre-specified endpoints linked to heart failure symptom improvement, hospitalization and survival.
LivaNova neuromodulation general manager Edward Andrle said: “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.
“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.”
Based in London, LivaNova has two businesses such as cardiac surgery and neuromodulation with operating headquarters in Mirandola of Italy and Houston of US.
This month, the company also completed erollment for a global aortic valve replacement clinical trial comparing the benefits of sutureless versus standard aortic valve replacement for aortic stenosis.
LivaNova completed enrollment for the Perceval sutureless implant against standard aortic Valve replacement (PERSIST-AVR) study with more than 900 patients from 47 centers in 12 countries.