• 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 » Gore wins FDA nod for Synecor preperitonial hernia repair system

Gore wins FDA nod for Synecor preperitonial hernia repair system

June 7, 2017 By Fink Densford

W.L. Gore & Associates said today it won FDA 510(k) clearance for its Synecor preperitoneal biomaterial hernia repair device, with plans to launch the device this week.

The Synecor preperitoneal biomaterial is a hybrid biosynthetic hernia repair device designed for use in single-stage preperitoneal, onlay and retromuscular placements through open, laparoscopic and robotic procedures, the Flagstaff, Ariz.-based company said.

“The hybrid of a permanent synthetic mesh with a long-term bioabsorbable in the Gore Synecor preperitoneal biomaterial is an innovative solution for preperitoneal hernia repairs, where the device’s placement between tissue layers makes tissue ingrowth especially desirable. I see immense value in the potential of this product to provide a single surgery that offers fast recovery, minimizes remaining material, and may reduce complications, such as mesh splitting and infection, when compared to the multi-surgery staged repairs required in some complex cases,” Dr. William Cobb said in a press release.

The device is designed with 3 layers, including a macroporous knit of monofilament polytetrafluoroethylene fibers and 2 surrounding layers of Gore Bio-A web bioabsorbably copolymer scaffolds to facilitate tissue ingrowth and vascularization on both sides of the device, the company said.

“We tailored the PTFE material’s microstructure, porosity, and form to match this application, making this device distinct even among other hernia repair products. In hernia surgery, total cost of care can vary widely if complications occur, which is why we used a unique combination of high-quality materials to reduce the potential for most common complications. Additionally a biosynthetic product like Gore Synecor preperitoneal biomaterial can be less than half the cost of commonly used biologic meshes and can be used in place of biologic and permanent, synthetic meshes in clean and clean high-risk patient types, overall providing strong clinical and economic value to providers,” general medical products biz lead David Lane said in a press release.

Last month, Gore said it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region.

Filed Under: 510(k), Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: W.L. Gore & Associates

More recent news

  • Data backs DermaSensor skin cancer detection device
  • GE HealthCare expands digital imaging portfolio with enhanced MIM Encore software
  • Accelus wins FDA clearance for MRI compatibility of FlareHawk spinal implants
  • Presidio wins FDA IDE for ultra-low frequency neuromod, hires new CFO
  • Epiminder study backs implantable EEG tech

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