• 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 » A unanimous thumbs up for Cook’s Zilver stent

A unanimous thumbs up for Cook’s Zilver stent

October 14, 2011 By MassDevice staff

Cook Medical

After more than a year in the works, Cook Medical’s Zilver PTX stent got a unanimous boost from the FDA’s Circulatory Systems Devices Panel, putting it on track for U.S. market clearance in the next few months.

If approved, the device will be the first of its kind for the treatment of femoropopliteal arteries.

Click here to read MassDevice’s Q&A with Cook Medical VP and peripheral interventional global leader Rob Lyles from July 2010

The Zilver device is a self-expanding drug-eluting stent coated in paclitaxel and used in treatment of peripheral artery disease.

Cook filed its PMA application in June 2010, and has had CE Mark approval for sales in Europe since 2009.

"Cook Medical is very pleased that the FDA’s Circulatory System Devices Panel has recognized the merits of Zilver PTX, and we look forward to a final decision on approval to market this device in the U.S. from the FDA in the coming months,” VP and global peripheral intervention unit leader Rob Lyle said in a press release. “Cook Medical is dedicated to continually innovating and delivering medical devices that improve the quality of patient care worldwide, and we wholeheartedly feel Zilver PTX provides a great example of that patient-focused business philosophy.”

"Between the U.S. and Europe, PAD affects almost 27 million people. It is a very serious condition. Your five-year survivability with PAD is worse than several cancers, including colon cancer. It’s actually worse than if you have a heart attack," Rob Lyles, vice president & global leader of Cook Medical’s peripheral intervention unit told MassDevice last year. "There’s tremendous patient need there."

With FDA approval, Cook will be competing directly over the U.S. PAD market with medical device giant Medtronic Inc. (NYSE:MDT).

Filed Under: Drug-Eluting Stents, News Well, Stents Tagged With: Cook Medical

More recent news

  • Johnson & Johnson MedTech launches new Volt plating systems for radius, humerus
  • PharmaSens, SiBionics collab on all-in-one insulin patch pump
  • Beta Bionics to pair iLet automated insulin delivery system with Abbott’s dual glucose-ketone sensor
  • Anaconda Biomed wins CE mark for funnel catheter
  • FDA approves Neuspera neuromod for urinary incontinence

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