• 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 » Stentys enrolls 1st patient in U.S. stent trial

Stentys enrolls 1st patient in U.S. stent trial

May 21, 2013 By Sony Salzman

Stentys

Stentys SA (EPA:STNT) hoping a new U.S. clinical trial will help it win pre-market approval for a self-apposing coronary stent.

The Princeton, N.J.- and Paris-based medical device company said it enrolled the 1st patient in its Apposition V trial, under an investigational device exemption from the U.S. watchdog agency.

The randomized, 2-arm study will enroll up to 880 heart attack patients at 50 sites. Stentys is comparing patient outcomes with its self-apposing stent to Abbott’s (NYSE:ABT) multi-link stent out to 12 months.

"This is a historic milestone for Stentys, as we begin the U.S. trial that will allow us to file our marketing application with the FDA," CEO Gonzague Issenmann said in prepared remarks. "The Stentys Self-Apposing Stent has the potential to replace the current gold standard of conventional balloon-expandable stents in the AMI setting."

In 2012, the company won its IDE for the trial. Stentys went head-to-head with Medtronic’s (NYSE:MDT) Resolute device in the Apposition Ive clinical study launched in 2012.

Filed Under: News Well, Pre-Market Approval (PMA), Stents Tagged With: Abbott, Clinical Trials, Investigational Device Exemption (IDE), Stent Wars, Stentys

More recent news

  • Autonomix picks up key nerve ablation catheter patent
  • Affluent Medical can move to pivotal phase of artificial urinary sphincter study
  • Globus Medical announces $500M share repurchase program
  • Cook Medical warns of issue with angiographic catheter
  • Virtuoso Surgical reports first cases with robotic endoscopy system, plans FDA IDE submission

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