• 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 » FDA approves Gore’s Viabahn VBX stent graft for iliac artery lesions

FDA approves Gore’s Viabahn VBX stent graft for iliac artery lesions

January 30, 2017 By Brad Perriello

Gore Viabahn VBXW.L. Gore & Assoc. said today that it won FDA approval for its Viabahn VBX stent graft for treating iliac artery lesions, including those found at the aortic bifurcation.

Flagstaff, Ariz.-based Gore said the approval means the device is the only balloon-expandable stent graft indicated for the iliac artery.

“The VBX stent graft combines radial strength with trackability and implanted conformability that results in successful outcomes for patients, providers and physicians,” peripheral intervention leader Ray Swinney said in prepared remarks.

“The VBX stent graft demonstrated notable immediate and 9-month safety and efficacy in treating patients with iliac occlusive disease, which can be attributed to the exceptional device design,” added Dr. Jean Bismuth of the Houston Methodist Hospital. “Overall, there were multiple clinical benefits observed, including no median change in the device length upon deployment and a 100% technical success rate with no occurrences of stent dislodgment or significant residual stenosis. The study device performed well in disadvantaged lesions, including occlusions, which speaks to its trackability, radial strength, conformability and stent retention.”

Gore said its 134-patient investigational device exemption study, VBX Flex, showed a 100% success rate in device delivery and target lesion coverage. The success rate for reducing target lesions to 30% or less of the original stenosis was also 100% and there was no change in median device length on deployment, the company said.

Primary patency was 96.9% at 9 months and 95.3% in patients with lesions that usually require open surgery. There were no incidents of device dislodgment, stent failure or serious adverse events, Gore said.

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Stent Grafts Tagged With: W.L. Gore & Associates

More recent news

  • Omnipod 5 rollout for type 2 rolls on as Insulet pursues next-gen automation
  • Ancora Heart reaches enrollment milestone in pivotal heart failure device trial
  • PharmaSens, SiBionics innovatively combine tech in all-in-one insulin patch pump
  • Johnson & Johnson launches daily disposable multifocal toric contact lens
  • Study backs Biolinq intradermal sensor in muscle loss prevention during GLP-1 therapy

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