• 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 » St. Jude Medical wins CE Mark for larger Portico heart valve

St. Jude Medical wins CE Mark for larger Portico heart valve

December 12, 2013 By Brad Perriello

St. Jude Medical wins CE Mark for larger Portico valve

St. Jude Medical (NYSE:STJ) said it won CE Mark approval in the European Union for the 25mm version of its Portico replacement heart valve.

The Portico device, a transcatheter aortic heart implant, is designed to be repositionable during the procedure, meaning surgeons can redeploy or retrieve the device when treating aortic stenosis.

"The Portico valve is an important part of our growing portfolio of products that treat valvular disease and heart failure. The approval of this 25 millimeter valve size will allow us to expand our footprint in the global [TAVI] market and provide a promising solution for patients with severe aortic stenosis," cardiovascular & ablation technologies president Frank Callaghan said in prepared remarks.

The 23mm Portico version won CE Mark approval in November 2012. St. Jude said it expects to get 2 more sizes on the market next year, "which will expand the eligible range of patients to those with annulus sizes ranging from 19 to 27mm," according to a press release.

Both the 23mm and 25mm Portico valves are the subjects of a U.S. clinical trial aimed at winning nods from the FDA. Results from the trials, presented in October at the Transcatheter Cardiovascular Therapeutics conference, showed a 3.6% mortality rate, 2.4% major stroke rate, 10.8% pacemaker implantation rate and 10.8% major bleeding rate after 30 days.

Filed Under: News Well, Regulatory/Compliance, Replacement Heart Valves Tagged With: CE Mark, Minnesota, stjudemedical

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