• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Butterfly Network Appoints New Leader

    BD Names Chairman of Board

    Interplex Acquires OCP Group

    FDA Clears a Portable Hemodialysis System

    Solid Growth Forecast for India's HER2 Amplification Tests Market
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    K-Tube Technologies

    Qosina Corp.

    Medicoil

    PTI Engineered Plastics Inc.

    FUTEK Advanced Sensor Technology Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Unicep

    Medicoil

    MW Life Sciences

    K-Tube Technologies

    Creganna Medical, part of TE Connectivity
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Clears Surgical Innovation Associates' Bioabsorbable Mesh for Reconstructive & Cosmetic Surgery

    Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue.

    FDA Clears Surgical Innovation Associates
    Related CONTENT
    • A 'Trial and Error' Approach to Micromolded Parts
    • Tooling Precision is Key to Micromolding Success
    • Smaller Cavity Features Not Always Sensible for Micromolded Products
    • Miniaturization of Medical Devices Creating Big Assembly Challenges
    • The Big Challenges of Medical Device Miniaturization
    Business Wire09.07.18
    Surgical Innovation Associates (SIA), a start-up medical device company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for DuraSorb Monofilament Mesh, the first in a line of advanced bioabsorbable technologies for reconstructive and cosmetic surgery.
     
    Each year, more than 1 million Americans are implanted with surgical mesh to provide the soft tissue support that is necessary in a variety of general and plastic surgical procedures. Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue—providing strong support during the critical initial phases of healing—and then slowly dissolve, leaving the patient free from foreign material within one year. The device brings cutting-edge polymer science and evidence-based engineering to bear on a material that has been safely used in other surgical applications for decades. DuraSorb will be released in select geographies in early 2019.
     
    “The idea of a mesh that is there when you need it and gone when you don’t is appealing, for much the same reason that absorbable sutures have become a key part of a surgeon’s armamentarium—tissue support from a foreign material is crucial during healing, but at some point thereafter may become a liability,” says Dr. John Kim, inventor of the device and Professor of Plastic Surgery at Northwestern University. “This technology was developed in direct response to unmet clinical needs in our field.”
     
    Complications following mesh placements can range from long-term pain to non-healing wounds. Historically there has been a dichotomy between permanent synthetic meshes and biologic meshes. Permanent synthetics provide favorable long-term support in hernia surgery and abdominal wall reconstruction. However, they are known to expose patients to long-term risk of pain, non-healing wounds and complications during later operations. Biologic meshes—derived from human or animal cadavers—promise long-term biocompatibility once they integrate into the patient’s tissue, but carry excessively high cost, risk of adverse inflammatory reactions and mixed clinical results.
     
    “Having known people who have gone through the pain of multiple mesh-related operations, I found it gratifying to collaborate closely with opinion-leading surgeons to make DuraSorb a reality,” says Alexei Mlodinow, CEO of SIA. “Their guidance went into every key decision during product development, and will now steer our clinical trial strategy as we replicate our robust preclinical data in a real-world setting.”
    Related Searches
    • northwestern university
    • company
    • hernia
    • engineering
    Related Knowledge Center
    • Surgical
    Suggested For You
    A A 'Trial and Error' Approach to Micromolded Parts
    Tooling Precision is Key to Micromolding Success Tooling Precision is Key to Micromolding Success
    Smaller Cavity Features Not Always Sensible for Micromolded Products Smaller Cavity Features Not Always Sensible for Micromolded Products
    Miniaturization of Medical Devices Creating Big Assembly Challenges Miniaturization of Medical Devices Creating Big Assembly Challenges
    The Big Challenges of Medical Device Miniaturization The Big Challenges of Medical Device Miniaturization
    Pharmaceutical Focus: A Look at Combination Products Pharmaceutical Focus: A Look at Combination Products
    Fixing Face Mask Form and Function Fixing Face Mask Form and Function
    Advanced Technology for Staking and Swaging Medical Plastics Advanced Technology for Staking and Swaging Medical Plastics
    Qosina Stocks Popular SmartSite™ Swabbable Needle-free Injection Sites Qosina Stocks Popular SmartSite™ Swabbable Needle-free Injection Sites
    Heated Face Mask Filters and Inactivates Coronaviruses Heated Face Mask Filters and Inactivates Coronaviruses
    Qosina Partners with Resolution Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing Qosina Partners with Resolution Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing
    Surgical Innovation Associates Appoints Chief Commercial Officer Surgical Innovation Associates Appoints Chief Commercial Officer
    FDA OKs Deep Blue Medical FDA OKs Deep Blue Medical's T-Line Hernia Mesh
    The Medtech Supply Chain and COVID-19 The Medtech Supply Chain and COVID-19
    Glaukos CEO Joins Avedro’s Board of Directors Glaukos CEO Joins Avedro’s Board of Directors

    Related Breaking News

    • Cardiovascular | Surgical
      Haemonetics to Acquire Cardiva for Up to $510M

      Haemonetics to Acquire Cardiva for Up to $510M

      Enhances penetration into the large and growing interventional cardiology and electrophysiology markets.
      PR Newswire 01.20.21

    • Cardiovascular | Surgical
      Abbott Wins Expanded Medicare Coverage for MitraClip

      Abbott Wins Expanded Medicare Coverage for MitraClip

      Includes patients with secondary (or functional) mitral regurgitation resulting from heart failure.
      Abbott Laboratories 01.20.21

    • Surgical
      Freehand Partners with Imperial Medical Solutions

      Freehand Partners with Imperial Medical Solutions

      Supports the introduction of its surgical robots in India, Sri Lanka, Malaysia and the Caribbean.
      Freehand 01.19.21


    • Surgical
      TransEnterix Wins EU Approval for Robotic Surgical Machine Vision System

      TransEnterix Wins EU Approval for Robotic Surgical Machine Vision System

      Intelligent Surgical Unit enables augmented intelligence on the Senhance surgical system.
      Business Wire 01.19.21

    • Surgical
      Moon Surgical Expands Leadership Team

      Moon Surgical Expands Leadership Team

      Adds Jeffery Alvarez, David Noonan, and Nicolas Linard.
      Moon Surgical 01.14.21

    • Neurological | Surgical
      FDA OKs ClearMind Biomedical

      FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

      Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.
      PR Newswire 01.12.21


    • Packaging & Sterilization | Surgical
      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      HEPA hinged door endoscope storage system addresses infection prevention needs in busy GI suites.
      Olympus 01.06.21

    • Surgical
      FDA Clears EndoRotor to Remove Dead Pancreatic Tissue

      FDA Clears EndoRotor to Remove Dead Pancreatic Tissue

      Treats patients with necrotic tissue resulting from complications of acute pancreatitis.
      U.S. Food and Drug Administration 01.04.21

    • Cardiovascular | Neurological | Surgical
      FDA OKs Rapid Medical

      FDA OKs Rapid Medical's Steerable Neurovascular Guidewire

      Provides efficient access in difficult neuro and peripheral vascular procedures.
      Business Wire 01.04.21


    • Surgical
      Clinical Trial to Study Impact of ActivePure Technology on Surgical Site Infections

      Clinical Trial to Study Impact of ActivePure Technology on Surgical Site Infections

      The study will use 50 noncardiac, adult operating rooms at Cleveland Clinic.
      Aerus Medical 12.14.20

    • Cardiovascular | Surgical
      Foldax Earns FDA Approval for Biopolymer Mitral Heart Valve Study

      Foldax Earns FDA Approval for Biopolymer Mitral Heart Valve Study

      Valve designs intended to resist calcification, withstand stresses and strains without failure.
      Business Wire 12.14.20

    • Surgical
      Aspen Surgical Acquires Protek Medical Products

      Aspen Surgical Acquires Protek Medical Products

      Acquisition bolsters Aspen’s portfolio of patient and staff safety products.
      Business Wire 11.24.20


    • Surgical
      FDA Clears Penumbra

      FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary Embolism

      Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots.
      Business Wire 11.20.20

    • Diagnostics | Surgical
      Allotrope Medical

      Allotrope Medical's StimSite Wins FDA Nod

      Lets surgeons use existing surgical instruments to help locate, identify ureters using electrical stimulation.
      PR Newswire 11.18.20

    • Cardiovascular | Surgical
      Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve

      Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve

      Voluntary recall is related solely to the delivery system.
      PR Newswire 11.17.20


    Trending
    • Senseonics Forges Strategic Collaboration With Ascensia Diabetes Care
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Top 10 Trends In The Medical Device And Equipment Industry
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Breaking News
    • Butterfly Network Appoints New Leader
    • BD Names Chairman of Board
    • Interplex Acquires OCP Group
    • FDA Clears a Portable Hemodialysis System
    • Solid Growth Forecast for India's HER2 Amplification Tests Market
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Omega-3s Evidenced to Reduce Low-Grade Inflammation in Elderly Men
    MIND and Mediterranean Diets Linked to Later Onset of Parkinson’s Disease
    Kerry Launches Web-Based Tool for Plant-Based Formulation Challenges
    Coatings World

    Latest Breaking News From Coatings World

    Keyland Polymer UV Powder, LLC Launches UVMax Defender
    Scott McLaughlin to Race in PPG Colors During Rookie INDYCAR Season
    Vink Chemicals Offers parmetol PSG
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Butterfly Network Appoints New Leader
    BD Names Chairman of Board
    Interplex Acquires OCP Group
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Adare Pharma Solutions Opens New Small-Scale Lab
    Stevanato Group Launches After-sales Service Offering
    X-Chem Acquires IntelliSyn and AviSyn
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Estée Lauder Companies Announces Game-Changing Sustainability Goals for Travel Retail
    Aura Introduces Customizable Hair Care
    Corpack Creates Custom Packaging for Marlies Möller Hair Care Line
    Happi

    Latest Breaking News From Happi

    Nice-Pak Receives EPA Approval for Disinfectant Wipes
    Symrise Shares 2020 Sales Figures
    Harry’s Launches ‘Headquarters’
    Ink World

    Latest Breaking News From Ink World

    Epson Partner Creates Label Applicators for Pharmaceutical Products
    Smurfit Kappa Sets New Sustainability Targets with Better Planet 2050
    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Great Lakes Label debuts new website
    Epson partner creates label applicators for pharmaceutical products
    ACTEGA removes chemicals from laminating adhesives
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    American Made Production Equipment for Mask Manufacturers
    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Spinal Elements' Lucent XP-Curved Expandable TLIF Gains FDA Nod
    FDA OKs OrthoSpin's 2nd Gen Robotic, Digital External Fixation System
    Nextremity Solutions Enters Supply Agreement with Fort Wayne Metals
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    North American Semiconductor Equipment Industry Posts December 2020 Billings
    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    PRINTING United Alliance Announces TAGA Presents Virtual Event

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login