• 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
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    FDA OKs Roche's Nasal Swab MRSA Test

    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs

    Eye Test for Parkinson's Gains Breakthrough Designation

    Biomerics Forms New Business Unit

    J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    From Genome Sequencing to the World’s First Portable MRI

    An Update on Digital Health

    ‘If You’re Reading This, You Need to Be at This Meeting’

    Five Steps for Succeeding Globally in Medtech

    Unlocking Market Doors with Real-World Evidence
    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
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    S-Y-M Products Company

    Zeus

    Nelson Laboratories LLC

    Halkey-Roberts Corporation

    Aran Biomedical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Understanding Key Processes for Mixing APIs with Silicone

    How to Minimize Color Variations in Your Medical Device

    Don’t Touch: Gesture Tech Is Reshaping How We Interact with Devices

    Revenue-Based Financing: A New Form of Growth Capital

    Pre-Filled Safety Syringes and the Self-Administration Trend
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Pulse Systems

    Zeus

    S-Y-M Products Company

    K-Tube Technologies

    Aran Biomedical
    • 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
    • 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

    Medtronic Stent Graft System Receives FDA Breakthrough Device Designation

    Developed to treat thoracoabdominal aortic aneurysm.

    Medtronic Stent Graft System Receives FDA Breakthrough Device Designation
    The Valiant TAAA is currently being evaluated in the U.S. within five physician-sponsored investigational device exemption trials for treatment of TAAA. Image courtesy of Medtronic.
    Related CONTENT
    • Philips & Medtronic Partner to Develop Image-Guided AFib Device
    • Promising Results from First-in-Human Test of Medtronic's Extravascular ICD System
    • Medtronic Launches Telescope Guide Extension Catheter to Support Complex Coronary Cases
    • Medtronic's New Catheter System for HIS Bundle Pacing Wins FDA Nod
    • Medtronic & Tidepool Partner on Interoperable Automated Insulin Pump
    Globe Newswire10.08.19
    Medtronic has received Breakthrough Device designation from the FDA for its Valiant TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA). A TAAA is a complex condition causing a bulging of the aorta, which extends from the chest down into to the abdomen.
     
    The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
     
    The Valiant TAAA is currently being evaluated in the U.S. within five physician-sponsored investigational device exemption (PS-IDE) trials for treatment of TAAA. The Valiant TAAA is intended to offer an off-the-shelf endovascular solution with a size matrix to enable broad patient applicability for one of vascular surgery's most difficult pathologies.
     
    "Breakthrough designation from the FDA means that we will be able to deliver this much needed treatment to patients sooner than expected. With an open surgery mortality rate of 25%, it is critical that we deliver for this unmet patient need," said Murray Shames, M.D., professor and chief division of Vascular Surgery at the University of South Florida Morsani School of Medicine and an investigator for the Valiant TAAA. "Physicians and industry must continue to innovate and provide hope for those with challenging disease states."
     
    TAAA typically involves the branch arteries that supply blood to multiple internal organs and represents about 15% of all thoracic aneurysms. The standard of care is complex open surgery, which is associated with high morbidity and mortality, and 40% of patients are not considered candidates for treatment.
     
    "In addition to a high mortality rate for open surgical repair, physicians do not have good options when it comes to treatment for failed endografts," said John Farquhar, vice president and general manager of the Aortic business, which is part of the Cardiac and Vascular Group at Medtronic. "The FDA's breakthrough designation for Valiant TAAA and our collaboration with leading physicians is an example of our willingness to take a courageous approach and challenge the limitations of current treatment options. This is about going further, together to improve patient outcomes."
    Related Searches
    • medtronic
    • aneurysms
    • surgical
    • president
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Medtronic Recalls Catheters Due to Separation and Fragmentation Issue Medtronic Recalls Catheters Due to Separation and Fragmentation Issue
    Highmark Interactive Receives FDA Clearance for Gamified Neurological Testing Platform Highmark Interactive Receives FDA Clearance for Gamified Neurological Testing Platform
    Top 10 Health Technology Hazards for 2020 Top 10 Health Technology Hazards for 2020
    Medtronic Submits InterStim Micro Neurostimulator and SureScan MRI Leads to FDA Medtronic Submits InterStim Micro Neurostimulator and SureScan MRI Leads to FDA
    FlowMet-R Gets FDA 510K Clearance FlowMet-R Gets FDA 510K Clearance
    Study Compares DES in High-Bleeding Risk Patients with One-Month of DAPT Study Compares DES in High-Bleeding Risk Patients with One-Month of DAPT
    FDA Encourages Patient Engagement in Medical Device Clinical Investigations FDA Encourages Patient Engagement in Medical Device Clinical Investigations
    FDA Approves Medtronic FDA Approves Medtronic's Evolut PRO+ TAVR System
    FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k) FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)
    Apollo Endosurgery Receives 510(k) Clearance for Suture-Anchor Component Apollo Endosurgery Receives 510(k) Clearance for Suture-Anchor Component
    Medtronic Introduces Envision Pro CGM System in Europe Medtronic Introduces Envision Pro CGM System in Europe
    Mike on Medtech: Benefit-Risk Determinations Mike on Medtech: Benefit-Risk Determinations
    1. Medtronic 1. Medtronic
    U.S. May Offer a Safe Harbor from the Impending MDR Storm U.S. May Offer a Safe Harbor from the Impending MDR Storm
    Healthcare, Breakthrough Technology, and the 2020 Election: A Summer Update Healthcare, Breakthrough Technology, and the 2020 Election: A Summer Update

    Related Breaking News

    • Cardiovascular | Patient Monitoring
      VivaLNK Wearable Sensor and Software Development Kit Receive CE Mark

      VivaLNK Wearable Sensor and Software Development Kit Receive CE Mark

      The reusable patch weighs only 7.5 grams.
      PRNewswire 12.03.19

    • Cardiovascular | Surgical
      CryoLife

      CryoLife's Thoraco-abdominal Stent Graft Gains CE Mark

      First off-the-shelf option with pre-cannulated inner branch technology.
      PR Newswire 12.03.19

    • Cardiovascular
      Concept Medical Granted CE Certification for its Sirolimus Coated MagicTouch Group of Products

      Concept Medical Granted CE Certification for its Sirolimus Coated MagicTouch Group of Products

      Company is now focused on marketing the products in Europe.
      Businesswire 11.25.19


    • Cardiovascular
      Bristol-Myers Squibb-Pfizer Alliance, Fitbit Partner to Address Gaps in Afib Detection

      Bristol-Myers Squibb-Pfizer Alliance, Fitbit Partner to Address Gaps in Afib Detection

      Companies are joining forces to develop atrial fibrillation educational content to help identify and support those at increased risk of stroke.
      Businesswire 11.25.19

    • Cardiovascular | Digital Health
      Biofourmis Partners with Novartis

      Biofourmis Partners with Novartis

      Teams up to offer digital therapeutics for patients with heart failure.
      Biofourmis 11.19.19

    • Cardiovascular
      First Patient in Middle East Treated With CSI

      First Patient in Middle East Treated With CSI's Peripheral Orbital Atherectomy Technology

      Introduction of Orbital Atherectomy expands treatment options for patients with peripheral artery disease.
      Business Wire 11.19.19


    • Cardiovascular | Materials | Tubing & Extrusion
      CVC Manufactured from Special Urethane Material that Becomes Softer in the Body

      CVC Manufactured from Special Urethane Material that Becomes Softer in the Body

      Optimized design of central venous catheters reduces risk of complications.
      Flexan 11.18.19

    • Cardiovascular | Digital Health | Patient Monitoring | Software & IT
      Preventive Healthcare via Apps

      Preventive Healthcare via Apps

      Prevention through digital helpers from Fraunhofer and partners.
      Fraunhofer-Gesellschaft 11.18.19

    • Cardiovascular | Contract Manufacturing | Materials | Tubing & Extrusion
      Freudenberg Medical Launches Wave of Product and Process Innovations

      Freudenberg Medical Launches Wave of Product and Process Innovations

      Among new innovations is Helix iMC, a new technology to continuously measure the inner geometry of silicone tubes.
      Freudenberg Medical 11.18.19


    • Cardiovascular | Neurological | Surgical
      Neural Networks Enable Autonomous Navigation of Catheters

      Neural Networks Enable Autonomous Navigation of Catheters

      AI support for endovascular stroke therapy.
      Fraunhofer-Gesellschaft 11.18.19

    • Cardiovascular
      PQ Bypass Receives Unconditional IDE Approval From FDA to Start TORUS SFA Stent Graft Study

      PQ Bypass Receives Unconditional IDE Approval From FDA to Start TORUS SFA Stent Graft Study

      TORUS-2 marks second Investigational Device Exemption approved for company in less than two years.
      Business Wire 11.15.19

    • Cardiovascular | Patient Monitoring | Software & IT
      FDA OKs Ultromics

      FDA OKs Ultromics' AI-Powered Decision Support System

      AI automates cardiac analysis helping earlier detection of cardiovascular disease, enabling clinicians to improve patient care and outcomes.
      PR Newswire 11.14.19

    • Cardiovascular
      THI’s Research Team Receives a Federal Grant

      THI’s Research Team Receives a Federal Grant

      Is developing a wireless and leadless pacemaker system.
      Texas Heart Institute 11.13.19

    • Cardiovascular
      Third-Party Evaluation Confirms Safety Profile of Philips Stellarex Low-Dose Drug-Coated Balloon

      Third-Party Evaluation Confirms Safety Profile of Philips Stellarex Low-Dose Drug-Coated Balloon

      Data show no difference in mortality between patients treated with the Philips Stellarex DCB and those treated with percutaneous angioplasty.
      Globe Newswire 11.11.19

    • Cardiovascular
      Study Shows Safety, Efficacy of Near Infrared Spectroscopy Imaging to Identify MACE Risk

      Study Shows Safety, Efficacy of Near Infrared Spectroscopy Imaging to Identify MACE Risk

      Trial identified both vulnerable patients and plaques that are at significantly higher risk for subsequent major adverse cardiac events.
      Business Wire 11.08.19


    Breaking News
    • FDA OKs Roche's Nasal Swab MRSA Test
    • Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    • Eye Test for Parkinson's Gains Breakthrough Designation
    • Biomerics Forms New Business Unit
    • J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • Adding Fabrication Capabilities: Additive Manufacturing for Production Parts
    • Delivering the Goods: The Evolving World of Combination Products
    • Anxious Undertones: The 2019 Year in Review
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    International Scientific Society Calls for Omega-3 Blood Testing in Future Research
    Pharmactive Affron Saffron May Help Relieve Depression Symptoms
    Warmer Temperatures Could Lead to Concerning Levels of Arsenic in Rice
    Coatings World

    Latest Breaking News From Coatings World

    Cristo Rey High School Educator Named 2019 Axalta All-Pro Teacher of the Year
    Michelman Makes United Way of Greater Cincinnati’s List of Top 25 Corporate Campaigns
    BCF: Coatings Industry Reports Record Improvement in Waste, Recycling, Accident Rates
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs Roche's Nasal Swab MRSA Test
    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    Eye Test for Parkinson's Gains Breakthrough Designation
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Almac Awarded $1M BMGF Grant
    Vivera Pharma, Parexel Ink Clinical Services Agreement
    MedPharm Triples Capacity at RTP Site
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    WWP Wins Three NJPEC Awards
    Cat-Themed Beauty Collection to Launch in Japan
    Pantone Names Classic Blue the 2020 Color of the Year
    Happi

    Latest Breaking News From Happi

    Lip Lab Opening in Brooklyn
    Raining Rose Expands Exec Team
    Scott’s Sells Personal Care Production Site
    Ink World

    Latest Breaking News From Ink World

    ePac Flexible Packaging Expands into Asia Pacific Market
    Haney, HP Developing Sustainable Fashion Packaging for Heron Preston
    Addipel Moves to New HQ, Expands Production Facility
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    HP teams with Haney for sustainable packaging
    Tags & Labels Printing adds Heidelberg’s Versafire EP
    Austrian converter installs first Nilpeter press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Thrace to Relocate U.S. Capacity
    FiltXPO Speaker Line-Up Announced
    Nölken Incorporates Sustainable Wipes Packaging
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Appoints New Spine Business Leader
    Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    Synaptive Medical's Modus V Expands Into Spine Market
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    IDTechEx Show! Announces Graphene Award Winner
    OE-A Continues to Bring Future of Printed Electronics to CES 2020
    Avancis, Smit Thermal, HZB, CNRS, Solliace Team for Higher Efficiencies in CIGS

    Copyright © 2019 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.