• 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 » Edwards’ Sapien 3 TAVI wins expanded approval in Europe

Edwards’ Sapien 3 TAVI wins expanded approval in Europe

November 6, 2019 By Sean Whooley

Edwards Lifesciences (NYSE:EW) said today that it received CE Mark approval for expanded use of its Sapien 3 transcatheter aortic valve implantation (TAVI) system.

The expanded use if for treatment of patients with aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 TAVI is the first transcatheter heart valve system to win this indication in Europe, Edwards said in a news release. The device previously won CE Mark approval for high-risk patients in November 2018.

Edwards’ Sapien valves first won commercial approval in Europe in 2007 and has since treated hundreds of thousands of patients worldwide. The Sapien 3 TAVI first won European approval in January 2014 for the treatment of high-risk patients and eventually got the nod to expand to intermediate-risk patients. In December 2018, the FDA approved the Sapien 3 TAVI for high-risk or intermediate-risk patients in the U.S.

The company said the valve’s latest indication expansion in Europe follows the publication of data from the Partner 3 pivotal trial earlier this year in the New England Journal of Medicine. The Partner 3 trial showed the Sapien 3 TAVI system achieved a 46% reduction in the event rate for the primary endpoint of the trial (composite of all-cause mortality, all stroke and rehospitalization at one year).

Another study published in the Journal of the American College of Cardiology demonstrated advantages for low-risk patients treated with the Sapien 3 TAVI valve and showed that patients treated with it experienced a better quality of life at one year after the procedure.

“Now, all European patients diagnosed with aortic stenosis can be considered for TAVI with the Sapien 3 valve based on factors such as anatomical considerations or other individual needs rather than risk scores,” St. Johannes Hospital, Dortmund, Germany, director of the clinic for internal medicine Dr. Helge Möllmann said in the release. “This is particularly important for patients at low risk for surgery, whose only serious health issue may be aortic stenosis and who want to return to their lives more safely and quickly. Previously, their only treatment option was open-heart surgery, and this approval will expand access to the proven Sapien 3 valve.”

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Featured, Regulatory/Compliance, Replacement Heart Valves Tagged With: Edwards Lifesciences

More recent news

  • Medtronic reports first patient treated in study of multi-organ denervation for hypertension
  • Baxter turns to an automation company for its new CEO
  • Pristine Surgical appoints new CFO
  • Boston Scientific wins expanded FDA nod for Farapulse PFA
  • FDA warns on issue with J&J Abiomed pump controllers related to 3 deaths

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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