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Author: Stephan Beier

  • Milestone on the Path towards Clinical Approval for a Potential New Therapy for Resistant Hypertension

    Milestone on the Path towards Clinical Approval for a Potential New Therapy for Resistant Hypertension

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    Milestone on the Path towards Clinical Approval
    for a Potential New Therapy for Resistant Hypertension

    With the launch of the baroloop Multi-Center Trial (MCT), a key step towards clinical approval begins: the efficacy and safety of vagus nerve stimulation (VNS) will be systematically investigated across multiple European centers.

    What is the baroloop MCT?

    The study is a multicenter, prospective clinical trial. It examines the use of baroloop in patients for whom the recommended pharmacological treatment strategy for hypertension has failed. The approval study is being conducted in several specialized clinics across Europe.

    Study Objective

    The aim of the clinical trial is to demonstrate the clinical efficacy and safety of the baroloop system. The results are intended to support a European approval of the baroloop system for the treatment of patients in whom the recommended pharmacological therapy for hypertension has failed.

    Background: Why baroloop?

    baroloop selectively stimulates the vagus nerve to activate the body’s natural baroreflex, enabling controlled reduction of blood pressure. The system uses an implantable electrode to provide a long-term therapy option for resistant hypertension—a potentially life-threatening condition.

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

  • FDA Grants “Breakthrough Device Designation” for VNS Stimulation System

    FDA Grants “Breakthrough Device Designation” for VNS Stimulation System

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    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