FDA Grants “Breakthrough Device Designation”
for VNS Stimulation System

On October 30, 2023, the FDA granted our vagus nerve stimulation system the Breakthrough Device Designation. Since January 2024, neuroloop has also been participating in the FDA’s TAP program.

On October 30, 2023, the U.S. Food and Drug Administration (FDA) designated neuroloop’s implantable vagus nerve stimulator as a Breakthrough Device. The classification recognizes its potential to make a clinically significant contribution to the treatment of therapy-resistant hypertension.

baroloop is indicated as an adjunctive therapy to help reduce blood pressure in patients with resistant hypertension.

On January 31, 2024, neuroloop was additionally accepted into the FDA’s Total Product Life Cycle (TAP) Advisory Program. This program provides innovative medical device developers with early and continuous interaction with the FDA throughout the entire product life cycle – from development and clinical evaluation to market introduction.

These two milestones represent important steps on our journey to offering new therapeutic options for patients with resistant hypertension and to advancing the development of baroloop with determination and focus.

“The Breakthrough Device Designation and our inclusion in the TAP Program confirm the innovative nature of our technology and strengthen our commitment to consistently pursue our approach.”
— Esther Novosel, CEO

We would like to thank our team and our partners for their contribution to this achievement.
 

Press contact
neuroloop GmbH
Breisacher Straße 86, 79110 Freiburg, Germany
E-mail: info@neuroloop.de