Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Approves CVRx’s Barostim Neo For Heart Failure On Expedited Pathway

Executive Summary

The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.

You may also be interested in...



CVRx Raises $75M In IPO To Commercialize And Develop Heart Failure Therapy

The funds will support expanded commercialization of the company’s baroreflex activation stimulation technology to treat heart failure in patients with a low left-ventricular ejection fraction.

CMS Proposes Extra Payments On CustomFlex Iris, Single-Use Duodenoscope, Heart Device

The Centers for Medicare and Medicaid Services highlighted three FDA breakthrough devices it is proposing for additional pass-through payments in its 2021 outpatient pay rule.

Global Approvals Snapshot August 2019

An overview of the global medical device approvals in September, as captured by Medtech Insight's Approvals Tracker. Approvals of several major cardiovascular devices highlighted what was otherwise a slow month for medical device approvals.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT125519

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel