• 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
    FUTEK Advanced Sensor Technology Inc.

    Unicep

    maxon

    Medbio LLC

    Creganna Medical, part of TE Connectivity
    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
    maxon

    PTI Engineered Plastics Inc.

    K-Tube Technologies

    Medicoil

    Element
    • 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

    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
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • Endoscopic Hemostasis Devices Market Valued at $730 Million
    • Boston Scientific's Vercise Genus DBS Earns FDA Approval
    • CHF Solutions Appoints CEO
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    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
    • it
    • commercialization
    • patient
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Medtech Matters: Medtronic Medtech Matters: Medtronic's Robotic Surgery Status
    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Endoscopic Hemostasis Devices Market Valued at $730 Million Endoscopic Hemostasis Devices Market Valued at $730 Million
    Boston Scientific Boston Scientific's Vercise Genus DBS Earns FDA Approval
    CHF Solutions Appoints CEO CHF Solutions Appoints CEO
    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    CMS Expedites Breakthrough Device Access; Industry Applauds CMS Expedites Breakthrough Device Access; Industry Applauds
    CES News: Philips Highlights Healthcare at Home CES News: Philips Highlights Healthcare at Home
    Acutus Medical Launches AcQCross Transseptal System in Europe Acutus Medical Launches AcQCross Transseptal System in Europe
    Study Shows Lungpacer System Improves Diaphragm Strength by More Than 300 Percent Study Shows Lungpacer System Improves Diaphragm Strength by More Than 300 Percent
    New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System
    Vesper Medical Announces First Enrollment in the VIVID Trial Vesper Medical Announces First Enrollment in the VIVID Trial
    Katena Products Welcomes New CEO Katena Products Welcomes New CEO
    New Company Formed to Develop Peripheral Venous Disease Treatments New Company Formed to Develop Peripheral Venous Disease Treatments
    Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval

    Related Breaking News

    • Cardiovascular
      Alleviant

      Alleviant's Transcatheter Tech Obtains Breakthrough Status

      The technology offers a no-implant interatrial shunt therapy for heart failure patients.
      Sam Brusco, Associate Editor 01.25.21

    • Cardiovascular
      First Heart Failure Patient Treated With Impulse Dynamics

      First Heart Failure Patient Treated With Impulse Dynamics' CCM Therapy in Brazil

      The Optimizer delivers cardiac contractility modulation therapy, the company’s proprietary technology, to the heart.
      Business Wire 01.21.21

    • Cardiovascular
      Boston Scientific to Acquire Preventice for Up to $925M

      Boston Scientific to Acquire Preventice for Up to $925M

      Acquisition of external cardiac monitoring technologies, services provider to expand rhythm management diagnostics portfolio.
      PR Newswire 01.21.21


    • 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

    • Cardiovascular | Patient Monitoring
      Hillrom to Buy Bardy Diagnostics for $375M

      Hillrom to Buy Bardy Diagnostics for $375M

      Advances digital health offering with expansion into attractive ambulatory cardiac monitoring segment.
      PR Newswire 01.19.21


    • Cardiovascular
      Occlutech

      Occlutech's Atrial Flow Regulator Earns Breakthrough Status for HF

      First-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients.
      PR Newswire 01.19.21

    • Cardiovascular | Diagnostics
      FDA OKs MRI for Impulse Dynamics

      FDA OKs MRI for Impulse Dynamics' Optimizer CCM Delivery Systems

      FDA clears potential hurdle for many heart failure patients.
      Business Wire 01.19.21

    • Cardiovascular
      FineHeart Successfully Tests Wireless TET System

      FineHeart Successfully Tests Wireless TET System

      A breakthrough in treating patients with severe heart failure.
      FineHeart 01.18.21


    • Cardiovascular
      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      The use of TAVR over open surgical techniques for replacing an aortic valve has exploded globally in recent years.
      GlobalData 01.15.21

    • Cardiovascular
      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      Company adds to portfolio of 40 patents for catheter-based technology that leverages the power of the body’s natural fluid removal process.
      Business Wire 01.13.21

    • Cardiovascular
      Acutus Medical Launches AcQCross Transseptal System in Europe

      Acutus Medical Launches AcQCross Transseptal System in Europe

      The product is designed to improve safety and efficiency in any procedure requiring left heart access.
      Globe Newswire 01.08.21


    • 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

    • Cardiovascular
      Edwards Treats First Patient in Restore Clinical Trial

      Edwards Treats First Patient in Restore Clinical Trial

      Evaluates minimally invasive device for mitral valve disease.
      Edwards Lifesciences Corp. 12.21.20

    • Cardiovascular | Diagnostics
      Genetesis

      Genetesis' CardioFlux Imaging Tech Gains Breakthrough Status

      Leverages room temperature magnetometers to noninvasively measure heart’s naturally-generated magnetic fields.
      Business Wire 12.16.20


    Trending
    • Senseonics Forges Strategic Collaboration With Ascensia Diabetes Care
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Henry Schein Buys Majority Interest In Prism Medical Products
    • Top 10 Trends In The Medical Device And Equipment Industry
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    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
    FDA Takes Major Action on Hand Sanitizers from Mexico
    Symrise Shares 2020 Sales Figures
    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