• 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
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    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
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—Aug. 13

    'Graft-on-a-Chip' Built to Improve Vascular Graft Success

    Abbott Invests €440 in New Irish Facility

    FDA Approves Guardant Health's NGS-Based Companion Diagnostic

    Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    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
    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    Arthur G. Russell Co. Inc., The

    JBC Technologies
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Medical Computing: COM Express Processes Real-Time Data at the Edge

    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things

    Leveraging Open Healthcare Data Standards to Improve Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    Arthur G. Russell Co. Inc., The

    JBC Technologies
    • 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
    • eBook
    • Resources
    • Podcasts
    • 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

    New FDA MR-Conditional Labeling Approvals Expand Abbott's MRI-Ready Device Portfolio

    New MR-conditional labeling for two of the company’s most widely-used high voltage devices continue cadence of MRI approvals.

    New FDA MR-Conditional Labeling Approvals Expand Abbott
    The new MR-conditional labeling applies to the Quadra Assura CRT-D (left) and Fortify Assura ICD (right). Image courtesy of Abbott.
    Related CONTENT
    • FDA Approves Abbott's Portico with FlexNav TAVR System
    • Indago Announces $10 Million Financing Close and Name Change
    • FDA OKs NeuroOne's Evo sEEG Electrode
    • FDA Approves TransMedics' OCS Heart System for Donor Hearts
    • FDA OKs BrainsWay Deep TMS to Reduce Anxiety in Depressed Patients
    Abbott Laboratories01.03.18
    Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for the Quadra Assura MP Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Fortify Assura Implantable Cardioverter Defibrillator (ICD), two of the company's most widely-used high voltage medical devices. The approvals follow recent MR-conditional labeling approvals for the Assurity MRI pacemaker, Ellipse ICD and associated MRI-compatible leads, and further expand Abbott's portfolio of MRI-ready devices for patients indicated for ICDs and/or CRT-D devices who may need an MRI in the future.
     
    Physicians utilize ICDs to restore normal heart rhythms in patients at risk for experiencing potentially life-threatening heart rhythms; they implant CRT-D devices to help the lower chambers of the heart beat in rhythm in patients battling progressive congestive heart failure and improve blood flow throughout the body. For some patients, the potential need for a future MRI has made MR-conditional labeling important as physicians assess therapies and device options. As a result, Abbott has done extensive testing to demonstrate that these devices are safe in the most commonly-used MRI scanners.
     
    "For many patients who need an ICD or CRT-D device, receiving a device that is MRI-ready is a key benefit that can ensure future access to MRIs—an important and commonly-used diagnostic tool," said Avi Fischer, M.D., divisional vice president, medical affairs, and medical director of Abbott's cardiac rhythm management business. "We are excited to expand our portfolio and add MR-conditional labeling to the Fortify Assura ICD and Quadra Assura MP CRT-D to provide patients and their physicians additional peace of mind if those patients need an MRI in the future."
     
    In addition to MRI compatibility, Abbott's Fortify Assura ICD and Quadra Assura MP CRT-D also include the company's suite of TailoredTherapy features, which are designed to provide physicians additional flexibility and control in how they deliver therapy to treat their patient's cardiac arrhythmias and congestive heart failure, even as their patient's therapy needs change over time. With the TailoredTherapy feature set, the Fortify Assura ICD and Quadra Assura MP CRT-D help protect against the delivery of unnecessary therapy and continuously evaluate the condition of a lead to consistently deliver appropriate therapy. Combined with MRI compatibility, these features offer physicians additional options to leverage when managing patient care.
     
    The Quadra Assura MP CRT-D also offers Abbott's proprietary MultiPoint Pacing and SyncAV technology to provide additional options for CRT patients who are not responsive to traditional cardiac resynchronization therapy. With MultiPoint Pacing, Abbott allows physicians to "individualize" cardiac resynchronization therapy and shift their patient's treatment options from a single point of pacing to multiple options to better deliver therapy where needed. Abbott's SynvAV software allows a CRT device to detect real-time changes in a patient's cardiac condition and adjust therapy accordingly.
     
    As with all Abbott cardiac rhythm management devices, all therapy data captured by the Fortify Assura and Quadra Assura MP devices can be directly, securely and wirelessly sent to a patient's doctor through the Merlin.net Patient Care Network. This communication allows physicians to remotely monitor their patient's therapy and assess any need for intervention.
    Related Searches
    • communication
    • heart
    • icds
    • blood
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    FDA Approves Abbott FDA Approves Abbott's Portico with FlexNav TAVR System
    Indago Announces $10 Million Financing Close and Name Change Indago Announces $10 Million Financing Close and Name Change
    FDA OKs NeuroOne FDA OKs NeuroOne's Evo sEEG Electrode
    FDA Approves TransMedics FDA Approves TransMedics' OCS Heart System for Donor Hearts
    FDA OKs BrainsWay Deep TMS to Reduce Anxiety in Depressed Patients FDA OKs BrainsWay Deep TMS to Reduce Anxiety in Depressed Patients
    LifeSignals Inc. Receives FDA Approval for Remote Monitoring Platform LifeSignals Inc. Receives FDA Approval for Remote Monitoring Platform
    Nevro Corp Receives FDA Approval for Senza System Nevro Corp Receives FDA Approval for Senza System
    Avanos Medical Fined $22M for MicroCool Surgical Gown Misbranding Avanos Medical Fined $22M for MicroCool Surgical Gown Misbranding
    Receiving FDA Approval in Under One Month Receiving FDA Approval in Under One Month
    FDA Approves AtriCure FDA Approves AtriCure's EPi-Sense System for Persistent Afib
    Expanded FDA Approval for Medtronic Expanded FDA Approval for Medtronic's Arctic Front Cryoablation Catheter
    RSIP Vision Offers Real-Time Surgical Workflow Recognition for Robotic Surgery RSIP Vision Offers Real-Time Surgical Workflow Recognition for Robotic Surgery
    FDA Clears Neurescue FDA Clears Neurescue's Intelligent Balloon Catheter
    Global Diabetes Care Devices Market to Garner $39.4B by 2027 Global Diabetes Care Devices Market to Garner $39.4B by 2027
    J&J Vision ACUVUE Abiliti Overnight Lenses for Myopia Earn FDA Approval J&J Vision ACUVUE Abiliti Overnight Lenses for Myopia Earn FDA Approval

    Related Breaking News

    • Cardiovascular
      FDA Approves Abbott

      FDA Approves Abbott's Portico with FlexNav TAVR System

      Self-expanding TAVR valve features intra-annular (within the native valve) leaflets.
      PR Newswire 09.20.21

    • Indago Announces $10 Million Financing Close and Name Change

      Indago Announces $10 Million Financing Close and Name Change

      Lazurite Holdings is developing technology to create the operating room of the future.
      Business Wire 09.15.21

    • Neurological | Patient Monitoring
      FDA OKs NeuroOne

      FDA OKs NeuroOne's Evo sEEG Electrode

      Company's second FDA 510(k) clearance received.
      PR Newswire 09.08.21


    • Cardiovascular
      FDA Approves TransMedics

      FDA Approves TransMedics' OCS Heart System for Donor Hearts

      Indicated for preservation of DBD (donors after brain death) hearts.
      PR Newswire 09.07.21

    • Neurological
      FDA OKs BrainsWay Deep TMS to Reduce Anxiety in Depressed Patients

      FDA OKs BrainsWay Deep TMS to Reduce Anxiety in Depressed Patients

      Expanded depression indication further demonstrates company’s leadership position.
      GlobeNewswire 08.19.21

    Loading, Please Wait..

    Trending
    • BD Recalls Intraosseous Products Over Multiple Issues
    • Abbott Invests €440 In New Irish Facility
    • RSNA 2021: Canon Medical Unveils Vantage Fortian 1.5T MRI
    • Chronic, Infectious Disease Prevalence To Benefit Vital Signs Monitoring Market
    • 7 Considerations For Designing Medical Device Mechanisms
    Breaking News
    • MPO's Most-Read Stories This Week—Aug. 13
    • 'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    • Abbott Invests €440 in New Irish Facility
    • FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    • Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • 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

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Tazo Transitions to Regenerative Organic Agriculture
    Coatings World

    Latest Breaking News From Coatings World

    What are you Reading this Week?
    SONGWON Industrial Group Reports Strong Q2 Financial Results
    PPG Completes COLORFUL COMMUNITIES Project for Boys & Girls Clubs of Greater Houston
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—Aug. 13
    'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    Abbott Invests €440 in New Irish Facility
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AskBio Appoints Clinical Ops Executives
    SpectrumX Partners With UK Contract Manufacturer
    GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Arkay Chairman Emeritus Howard Kaneff Has Died
    Nutricosmetics Market to Hit $13.7 Billion by 2030
    Estée Lauder Pledges 100% Electric Fleet of Vehicles by 2030
    Happi

    Latest Breaking News From Happi

    Consumers are Clamoring for Vintage Glam: Spate
    Kayali’s Lovefest Fragrance, Newell’s New Candle and HydraFacial’s Record Financial Results
    Self Care Trumps Home Care Post-Covid
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Printing Ink Primer, Zeller+Gmelin Lead This Week’s News Stories
    Heidelberg Enjoys Successful Start to 2022-23 Fiscal Year
    Mimaki Announces New LATAM Website
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Esko, Constantia Flexibles announce acquisitions and more
    Hybrid Software joins The Flexo Xperience Center
    Flexo Wash LLC and Mike Potter celebrate 20 years
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Essity Switches to Recyclable Packs for Feminine Pads, FTC Sues PPE Maker on False Origin Claims & More
    Focke & Co. to Host Destination: Your Hygiene Hub on August 31
    Exports Dominate Chinese Trade of Tissues, Hygiene Products and Wipes
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—Aug. 13
    Dental 3D Printing Market is Expanding 20% Annually
    Study Results Released for Abbott's Concussion Blood Test
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: ALTANA, Universal Display and Emerson Top This Week’s Stories
    eMagin Corporation Announces 2Q 2022 Results
    Zebra Technologies’ Emission Reduction Targets Validated by SBTi

    Copyright © 2022 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