• 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
    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform

    Diagnostic Desperation: A Look at IVD Trends During COVID-19

    Resourceful Resources: Materials Make a Difference During the Pandemic

    Stressed Testing: Challenges with Medical Device Testing
    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
    EchoNous Expands Its Kosmos Hardware Platform

    Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

    Europe's Cross-Border Medtech Deal Activity Rises in Q4 2020

    Bio-Techne to Acquire Asuragen for $320M

    QUANTA Appoints Chief Operating Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform

    Diagnostic Desperation: A Look at IVD Trends During COVID-19

    Resourceful Resources: Materials Make a Difference During the Pandemic

    Stressed Testing: Challenges with Medical Device Testing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cybersecurity Compromises, Courtesy of COVID-19

    A Look at the Actual Device Costs for Hospitals

    Show Time: Here’s What a Year of No Tradeshows Meant for Small Businesses

    FDA Making Progress With Technology and Data Action Plans

    What’s Hot Now in Medtech M&A
    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
    maxon

    Medicoil

    PTI Engineered Plastics Inc.

    Creganna Medical, part of TE Connectivity

    Forefront Medical Technology
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Grant Funding Works and How It Can Help

    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    PTI Engineered Plastics Inc.

    MW Life Sciences

    maxon

    FUTEK Advanced Sensor Technology Inc.

    Qosina Corp.
    • 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 Approves the GORE TAG Conformable Thoracic Stent Graft With ACTIVE CONTROL

    The device and new delivery system optimize TEVAR outcomes in complex aortic anatomy.

    FDA Approves the GORE TAG Conformable Thoracic Stent Graft With ACTIVE CONTROL
    GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL. Image courtesy of Business Wire.
    Related CONTENT
    • FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
    • FDA OKs Neonatal Indication for Masimo's O3 Regional Oximetry
    • FDA Approves Gore's CARDIOFORM ASD Occluder to Treat Atrial Septal Defects
    • FDA OKs ControlRad's Radiation Reduction Technology that Integrates into Mobile C-arms
    • FDA Approves Device to Help Increase Access to More Lungs for Transplant
    Business Wire07.01.19
    W. L. Gore & Associates Inc. (Gore) announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for commercial distribution for the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System, a Thoracic Endovascular Aortic Repair (TEVAR) solution combining new levels of control with the legacy and performance of the Conformable GORE TAG Device. The device and delivery system provide new precision and predictable patient outcomes in the endovascular repair of aneurysms, transections, and Type B dissections of the descending thoracic aorta. A smaller-diameter primary delivery sleeve gives the device and system a lower profile across 10 device sizes.
     
    The GORE ACTIVE CONTROL System provides controlled, two-stage deployment, with primary deployment to an intermediate diameter and a secondary deployment to full diameter. This design allows for continuous blood flow throughout the deployment with multiple opportunities to visualize and refine graft placement. It is also designed to allow for angulation of the proximal end of the device for improved seal and apposition. It gives physicians added precision in placement and angulation so they can take full advantage of the exceptional conformability of the Gore device and confidently provide a minimally-invasive solution to more patients.
     
    No change was made to the stent graft itself, which, as the world’s most-studied* TEVAR device, has demonstrated long-term freedom from device-related reintervention (93.1 percent) and low complication rates (zero migrations, fractures, or compressions).** Large device oversizing windows were engineered, tested, and proven to accommodate differences in proximal and distal landing zone diameters; a unique 6 percent to 33 percent oversizing window allows physicians to choose the optimal radial force to fit patient anatomy and etiology, whether treating a young trauma patient or a fragile dissected aorta. The 16mm to 42mm range can be treated with as few as five sizes, allowing providers to stock fewer devices while treating a broader range of patients.
     
    “The GORE TAG Device family has a legacy of trusted performance and durability, and we knew we could build on that by enhancing control during deployment, which would help make TEVAR procedures more predictable for physicians,” said Eric Zacharias, a vascular business leader at Gore. “Physicians can now deploy our thoracic stent graft in the descending thoracic aorta with more operative ease, even in those patients with challenging angulated aortic arches, and meet the clinical and practical challenges of TEVAR with confidence. With this latest product iteration, Gore is continuing its unparalleled commitment to developing solutions that advance endovascular solutions for diseases of the aorta.”
     
    The GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System is part of the family of endovascular products that share a mission to effectively treat aortic disease, backed by Gore’s clinical support team and educational offerings. The portfolio of products includes the GORE EXCLUDER AAA Endoprosthesis for the treatment of abdominal aortic aneurysms (AAA). The GORE EXCLUDER Iliac Branch Endoprosthesis is the first U.S. Food and Drug Administration-approved, off-the-shelf device for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms, and is intended for use with the GORE EXCLUDER AAA Endoprosthesis.†
     
    * Based on company-sponsored trials and registries shown on clinicaltrials.gov for currently available stent grafts.
    ** Consolidated site reported outcomes following five years of follow-up in TAG 08-01, TAG 08-02, TAG 08-03 clinical studies.
    † For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).
     
    Gore engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration it is improving lives.
     
    W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments—from revolutionizing the outerwear industry with GORE-TEX fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its team-oriented culture and global recognition from the Great Place to Work Institute. Headquartered in Newark, Del., Gore employs 9,500 Associates and generates annual revenues of $3.5 billion. 
    Related Searches
    • institute
    • electronics
    • trauma
    • aortoiliac aneurysms
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
    FDA OKs Neonatal Indication for Masimo FDA OKs Neonatal Indication for Masimo's O3 Regional Oximetry
    FDA Approves Gore FDA Approves Gore's CARDIOFORM ASD Occluder to Treat Atrial Septal Defects
    FDA OKs ControlRad FDA OKs ControlRad's Radiation Reduction Technology that Integrates into Mobile C-arms
    FDA Approves Device to Help Increase Access to More Lungs for Transplant FDA Approves Device to Help Increase Access to More Lungs for Transplant
    ResMed Unveils Its First Top-of-Head-Connected Nasal Pillows CPAP Mask ResMed Unveils Its First Top-of-Head-Connected Nasal Pillows CPAP Mask
    A New, Tailored Review Framework for Artificial Intelligence-Based Devices A New, Tailored Review Framework for Artificial Intelligence-Based Devices
    EchoNous Releases All-Electronic Bladder Scanning Tool with State-of-the-Art Deep Learning Algorithm EchoNous Releases All-Electronic Bladder Scanning Tool with State-of-the-Art Deep Learning Algorithm
    3M Expands Adhesive Portfolio for Wearable Medical Devices 3M Expands Adhesive Portfolio for Wearable Medical Devices
    FDA to Modernize Mammography Services and Improve Their Quality FDA to Modernize Mammography Services and Improve Their Quality
    FDA OKs Masimo FDA OKs Masimo's Rad-67 Pulse CO-Oximeter
    FDA Warns J&J and Sientra for Breast Implant Compliance Failure FDA Warns J&J and Sientra for Breast Implant Compliance Failure
    FDA to Closely Examine Surgical Stapler Risks FDA to Closely Examine Surgical Stapler Risks
    FDA Commissioner Scott Gottlieb to Step Down FDA Commissioner Scott Gottlieb to Step Down
     Gore Introduces GORE TAG Conformable Thoracic Stent Graft With Reduced Profiles in Europe Gore Introduces GORE TAG Conformable Thoracic Stent Graft With Reduced Profiles in Europe

    Related Breaking News

    • Cardiovascular
      Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

      Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

      Will evaluate PulseSelect's pulsed electrical fields to interrupt irregular heart rhythms.
      Sam Brusco, Associate Editor 03.04.21

    • Cardiovascular
      Soundbite Medical Wins Health Canada Approval for PAD Treatment

      Soundbite Medical Wins Health Canada Approval for PAD Treatment

      Product targets patients with heavily calcified chronic total occlusions.
      Michael Barbella, Managing Editor 03.02.21

    • Cardiovascular
      Novel Heart Failure Treatment Technology Scores Positive Trial Results

      Novel Heart Failure Treatment Technology Scores Positive Trial Results

      All patients treated with Vascular Dynamics' MobiusHD Device showed improvement.
      Michael Barbella, Managing Editor 03.01.21


    • Cardiovascular
      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.
      Michael Barbella, Managing Editor 02.25.21

    • Cardiovascular
      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NCVC in Japan will develop computational models while NTT Research MEI Lab will implement a bio digital twin platform.
      Michael Barbella, Managing Editor 02.24.21

    • Cardiovascular
      RSIP Vision Announces New Coronary Artery Segmentation Tool

      RSIP Vision Announces New Coronary Artery Segmentation Tool

      New module utilizes deep learning algorithms combined with classic computer vision methods to create a 3D model of the coronary arteries.
      Charles Sternberg, Assistant Editor 02.18.21


    • Cardiovascular
      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Technology approved to treat calcified coronary plaque.
      Charles Sternberg, Assistant Editor 02.17.21

    • Cardiovascular
      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Informs physicians to cease use of the device until further notice.
      Charles Sternberg, Assistant Editor 02.17.21

    • Cardiovascular | Neurological
      Cerus Endovascular

      Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status

      Indicated for the treatment of intracranial aneurysms.
      Sam Brusco, Associate Editor 02.12.21


    • Cardiovascular
      Vascular Perfusion Solutions

      Vascular Perfusion Solutions' VP.S Encore Cardiac Transport Device Wins Breakthrough Status

      Enables preserving of vascularized tissue for eight hours.
      Sam Brusco, Associate Editor 02.09.21

    • Cardiovascular
      Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

      Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

      Data show an 86 percent survival rate for cardiomyopathy cardiogenic shock patients.
      Michael Barbella, Managing Editor 02.08.21

    • Cardiovascular
      FDA Clears Wearable Electrocardiogram Sensor

      FDA Clears Wearable Electrocardiogram Sensor

      The product offers extended ambulatory ECG recording up to three weeks.
      Michael Barbella, Managing Editor 02.08.21


    • Cardiovascular | Surgical
      Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

      Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

      There were no incidences of structural valve deterioration at the five-year mark.
      Sam Brusco, Associate Editor 02.01.21

    • Cardiovascular
      Medtronic Expands Release of Radial Artery Access Portfolio

      Medtronic Expands Release of Radial Artery Access Portfolio

      Completes first-in-patient procedure with newly acquired catheters.
      Charles Sternberg, Assistant Editor 02.01.21

    • Cardiovascular
      Medtronic

      Medtronic's DiamondTemp Ablation System Gains FDA Approval

      Treats patients with recurrent, symptomatic paroxysmal atrial fibrillation unresponsive to drug therapy.
      Sam Brusco, Associate Editor 01.29.21


    Trending
    • FDA Breakthrough Device Designation Awarded To BrainCool AB's Cooral System
    • Philips, Disney Join Forces To Reduce Childrens' MRI Anxiety
    • Mike On Medtech: Update On FDA's STeP Designation
    • Plastikos Medical Begins Phase II Of Expansion
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    Breaking News
    • EchoNous Expands Its Kosmos Hardware Platform
    • Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib
    • Europe's Cross-Border Medtech Deal Activity Rises in Q4 2020
    • Bio-Techne to Acquire Asuragen for $320M
    • QUANTA Appoints Chief Operating Officer
    View Breaking News >
    CURRENT ISSUE

    March 2021

    • Stressed Testing: Challenges with Medical Device Testing
    • Resourceful Resources: Materials Make a Difference During the Pandemic
    • Diagnostic Desperation: A Look at IVD Trends During COVID-19
    • Digitize Your QMS via an Enterprise Cloud Platform
    • Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts
    • 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

    IFT Transitions 2021 Annual Event to Digital Experience
    NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer
    Statins May Contribute to Vascular Calcification by Inhibiting Vitamin K-Dependent Proteins
    Coatings World

    Latest Breaking News From Coatings World

    Chromaflo Technologies Adds Benjamin Woeste as Territory Sales Manager
    Maroon Group Acquires Cary Company's Raw Materials, Specialty Chemicals Distribution Business
    Matt Fogel Named Mule-Hide's Territory Manager – Southern Virginia
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    EchoNous Expands Its Kosmos Hardware Platform
    Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib
    Europe's Cross-Border Medtech Deal Activity Rises in Q4 2020
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Amgen to Acquire Five Prime Therapeutics for $1.9B
    Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions
    CureVac, Novartis Ink COVID Vax Mfg. Pact
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Estée Lauder Establishes Equity and Engagement Center of Excellence
    L'Oreal On How It Will Shape Beauty's Future at Today's Transparency Summit
    C.O. Bigelow Earns Praise as NYC's Oldest Family-Run Apothecary
    Happi

    Latest Breaking News From Happi

    Avon Launches Vegan Skin Care Line
    Inolex Appoints VP Marketing
    Decorté Launches AI Diagnostics in US
    Ink World

    Latest Breaking News From Ink World

    Massilly North America Adds Koenig & Bauer MetalStar 3 Metal Decorating Press
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Henkel publishes 30th Sustainability Report
    Avery Dennison Smartrac launches new Circus Pro inlays
    Springfield Solutions highlights digital label embellishments
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    FPInnovations Develops Biodegradable Mask
    Sani Professional Sanitizing and Disinfecting Products Approved by EPA
    Autefa Solutions Offers Fully Automated Line for Protective Mask Production
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Bioventus Appoints Managing Director, China and Asia Pacific
    Full-Year Sales Down 12 Percent at Zimmer Biomet
    Lincotek Medical Expands Coatings and Additive Capacity
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    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