• 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 » TAVI: FDA approves Medtronic’s CoreValve Evolut R

TAVI: FDA approves Medtronic’s CoreValve Evolut R

June 23, 2015 By Brad Perriello

Medtronic's CoreValve Evolut RMedtronic (NYSE:MDT) said today that the FDA granted pre-market approval for its CoreValve Evolut R replacement heart valve, less than a week after approving the competing Sapien 3 valve made by Edwards Lifesciences (NYSE:EW).

The devices are 3rd-generation transcatheter aortic valve implants designed to treat leaky heart valves. Both the CoreValve Evolut R and the Sapien 3 are designed to reduce the paravalvular leakage that plagued earlier iterations.

“The FDA approval of Evolut R marks a significant milestone for Medtronic and TAVI, and ushers in a new era in transcatheter aortic valves with advanced, recapturable capabilities,” vice president Rhonda Robb said in prepared remarks. “This approval is an outcome of our commitment to building a market-leading innovation pipeline in the transcatheter space, and we look forward to supporting heart teams as they look to next-generation technologies that optimize valve performance for a broad range of patients.”

“In a short time, the TAVI procedure has become an established treatment option for high-risk patients with severe aortic stenosis who are unable undergo surgery, and physicians are looking to technology advancements to help deliver even better patient outcomes,” added Dr. Mathew Williams of New York’s NYU Langone Medical Center. “Clinical data have shown the best patient outcomes are achieved when the valve is properly positioned. The advancement of recapturability with Evolut R gives physicians more confidence during the procedure and provides advantages that are non-existent in other TAVR systems.”

Williams is co-principal investigator of Medtronic’s U.S. clinical study of the CoreValve Evolut R, which won CE Mark approval in the European Union in September 2014.

Filed Under: Business/Financial News, Food & Drug Administration (FDA), Replacement Heart Valves Tagged With: Edwards Lifesciences, Medtronic

More recent news

  • Medtronic partners with IRCAD on Hugo, Affera surgical training
  • 23andMe co-founder wins bid to take back control of company
  • Neurent Medical opens new manufacturing facility in Ireland
  • Brain Navi wins FDA nod for neurosurgical robot
  • Adona Medical completes enrollment in first-in-human interatrial shunt trial

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