• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Medtronic wins FDA nod for CoreValve Evolut Pro

Medtronic wins FDA nod for CoreValve Evolut Pro

March 22, 2017 By Fink Densford

Medtronic Corevalve

Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut Pro transcatheter aortic heart valve replacement designed for treating severe aortic stensosis.

The newly cleared, next-gen CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said.

“Medtronic remains committed to working with interventional cardiologists and cardiac surgeons to deliver solutions that address patient needs with the safety and performance profile they expect from Medtronic. We are excited to introduce the next evolution of our Evolut TAVR platform to provide physicians with a comprehensive portfolio to address their patients’ needs,” Medtronic heart valve therapies biz VP & GM Rhonda Robb said in a prepared release.

The clearance came backed by data from a clinical study of the Evolut Pro, which met its primary endpoint at 30 days and reported a 98.3% rate of survival and a 1.7% rate of disabling stroke, Medtronic said.

A total of 72.4% of patients in the trial experienced trace amounts of paravalvular leakage or none at all, with no incidents of moderate or severe PVL reported at 30 days.

“The 30-day clinical outcomes presented at ACC demonstrate the Evolut PRO valve to be an outstanding treatment option for patients with severe aortic stenosis who are at a high or extreme risk for surgery,” Dr. John Forrest of the Yale University School of Medicine said in a press release.

The Evolut Pro system is designed to be delivered through the EnVeo R delivery catheter system and is indicated for vessels as small as 5.5mm, Medtronic said. The CoreValve Evolut Pro is available in the US in 23mm, 26mm and 29mm sizes, the company said.

“Based on my experience implanting the Evolut PRO valve during the clinical study, I’ve been impressed by the clinical outcomes achieved in our patients This innovation represents an important advantage over previous generations of this device, as it can help assist with adequate sealing even in complex cases,” Dr. Mathew Williams of the NYU Langone Medical Center said in a prepared statement.

Last December, Medtronic said it won reimbursement and Shonin approval from the Japanese Ministry of Health, Labor & Welfare (MHLW) for its CoreValve Evolut R transcatheter aortic valve replacement.

Filed Under: Cardiovascular, Food & Drug Administration (FDA), Regulatory/Compliance, Replacement Heart Valves Tagged With: Medtronic

More recent news

  • Aurora Spine begins first procedures with Aero lumbar fusion system
  • Caranx Medical surgical robot TaviPilot AI software wins FDA clearance
  • InspireMD launches carotid stent in U.S. after FDA approval
  • Neuros Medical raises $56M Series D to support nerve stim tech
  • CorWave reports first-in-human LVAD implant

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy