• 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
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    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—March 25

    Getinge iCast Receives FDA Premarket Approval

    Tessy Plastics Corp. Celebrates 50th Anniversary

    Carium Expands Customization Options with Care Pathways

    InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    CR-SOP Neurotechnology Helps to Achieve ‘Sound’ Sleep

    Inside the Hospital Value Analysis Committee

    Face Time: Why Getting Engineers Out of the Lab Is Good for Business

    Common Paratubing Pitfalls and How to Avoid Them

    During Times of Uncertainty, Create Business Value with an Optimized Workforce
    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
    Cirtec Medical

    Halkey-Roberts Corporation

    Arthur G. Russell Co. Inc., The

    Medbio LLC

    Providence Enterprise USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing Medical Devices Revolutionized Manufacturing

    5 Current Trends in Medical Device Security

    How Advanced Sensors Improve Design & Functionality of Respiratory Care Equipment

    Sourcing Silicone Parts: Injection Mold or 3D Print?

    Cybersecurity in Healthcare: Getting on the Right Track
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    Halkey-Roberts Corporation

    Arthur G. Russell Co. Inc., The

    Medbio LLC

    Providence Enterprise USA Inc.
    • 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

    Expanded FDA Approval for Medtronic's Arctic Front Cryoablation Catheter

    For initial use for recurrent symptomatic paroxysmal atrial fibrillation.

    PR Newswire06.25.21
    Medtronic plc received U.S. Food and Drug Administration (FDA) expanded approval for the Arctic Front Family of Cardiac Cryoablation Catheters for the treatment of recurrent symptomatic paroxysmal atrial fibrillation (episodes that last less than seven continuous days) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy. The expanded indication is based on results from STOP AF First, a prospective, multicenter randomized study that demonstrated superior efficacy of the Medtronic cryoablation procedure for preventing atrial arrhythmia recurrence compared to the use of AAD therapy.
     
    Nearly 60 million people worldwide1 are affected by atrial fibrillation (AF). AF is a progressive disease, meaning over time patients can experience more frequent, and longer episodes, and medication as well as catheter ablation can become less effective. Additionally, AF is associated with serious complications including heart failure, stroke and increased risk of death2-5.
     
    Managing AF can be a lifelong burden for patients, and AAD therapy has been the current standard first-line treatment. However, AAD therapy is ineffective at controlling AF in approximately half of patients treated with drug therapy6-8 and AAD usage frequently causes side effects that can lead many to discontinue treatment.9 Only after experiencing AAD failure, do some patients then go on to receive a catheter ablation.
     
    "Expanded FDA approval, coupled with the growing body of clinical evidence, demonstrate cryoablation as a first-line treatment is a more effective solution for preventing atrial arrhythmia recurrence," said Oussama Wazni, M.D., section head, Electrophysiology, Cardiovascular Medicine, Cleveland Clinic and principle investigator for the STOP AF First clinical trial. "With this new indication, physicians now have more options to treat AF earlier, and we've seen that patients do better when treated earlier. Patients can now be referred for a cryoablation to effectively control their AF rather than trying drug therapy first, potentially allowing them get back to living their lives without the added anxiety of progressing AF symptoms and potential health complications."
     
    The Medtronic Arctic Front family of Cardiac Cryoablation Catheters are the first and only catheter ablation devices in the U.S. approved to help physicians improve AF patient outcomes before drug failure, and shorten the time from diagnosis to ablation with effective, efficient, and predictable outcomes.6 Three recent clinical trials showed the safety of the Medtronic cryoballoon and demonstrated the superiority of Arctic Front Cryoballoon ablation for preventing atrial arrhythmia recurrence in patients with paroxysmal AF (PAF) who have not failed AAD therapy.6-8
     
    • STOP AF First6, a Medtronic-sponsored, prospective, multicenter, randomized trial, included 225 patients at 24 sites in the U.S. Patients who had never received AAD therapy were randomized to cryoablation or AAD treatment and followed for 12 months. Results, published in the New England Journal of Medicine (NEJM) in Nov. 2020, reported 74.6 percent of patients in the cryoballoon versus 45.0 percent in the AAD group (P<0.001) achieved treatment success at 12 months. The quality of life (QoL) data published in NEJM demonstrate that cryoballoon ablation resulted in significant improvements in quality of life as assessed using the Atrial Fibrillation Effect on Quality-of-Life [AFEQT] and European Quality of Life–5 Dimensions [EQ-5D] questionnaires. A low rate of patient complications occurred when using catheter ablation as a first-line treatment (12-month rate of primary safety events: 1.9 percent), and the percentage of patients with a serious adverse event was similar between the treatment groups.
    • EARLY-AF8, an investigator-initiated, multicenter trial, randomized 303 patients with AF who had never received AAD to cryoballoon-based pulmonary vein isolation or first-line AAD therapy. Results from EARLY-AF, published in the New England Journal of Medicine (NEJM) in Nov. 2020 and presented at American Heart Association Scientific Sessions 2020, found 57.1 percent of patients in the cryoballoon versus 32.2 percent in the AAD group achieved freedom from atrial tachyarrhythmia recurrence at 12 months. Mean AF burden was lower in the cryoballoon (0.6±3.3 percent) vs. AAD group (3.9±12.4 percent). Patients treated with cryoablation demonstrated larger improvements in quality of life and more frequently had resolution of arrhythmic symptoms (e.g., fatigue, rapid heartbeat, shortness of breath) than patients receiving AAD therapy. Safety events were low in both groups with 3.2 percent of catheter ablation and 4.0 percent of AAD-treated patients experiencing a serious adverse event related to the trial regimen.
    • Cryo-FIRST7, a Medtronic-sponsored, randomized, multicenter trial, enrolled 220 patients at 18 sites in nine countries across Europe, Australia and Latin America. At 12 months, freedom from atrial arrhythmia recurrence was achieved in 82.2 percent of the cryoballoon and 67.6 percent of the AAD group. Cryo-FIRST demonstrated that more patients with PAF who received first-line treatment with Medtronic cryoablation vs. AAD therapy were asymptomatic at 12 months. Cryoablation resulted in significant improvement in in AF-specific health-related quality of life at 12 months compared to AAD therapy. The cryoablation and AAD arms had comparable safety profiles in terms of the rate of serious adverse events.
     
    "With this milestone announcement, Medtronic now has the only ablation catheter approved by the FDA to be used a as first-line treatment in the U.S. to treat AF. The indication expansion demonstrates how Medtronic continues to lead the way in cardiac ablation solutions for arrhythmia management and fill a market need for an early rhythm control strategy for what is an very progressive disease," said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "For the millions of Americans who struggle with simple, daily tasks like walking up the stairs or getting the mail because of their AF, the expanded indication offers an alternative treatment option to antiarrhythmic drug therapy."
     
    The FDA recently expanded the indication for Medtronic cryoablation therapy to include treating patients with drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months) as well as the treatment of recurrent symptomatic paroxysmal atrial fibrillation as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. Medtronic has pioneered cryoablation technology, with an industry-leading and extensive body of evidence, including proven safety and efficacy in treating AF. To date, nearly one million patients have been treated with the Medtronic cryoablation therapy worldwide.
     
    In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
     
    References
    1 Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
    2 Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
    3 Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
    4 Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
    5 Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126
    6 Wazni OM, Dandamudi G, Sood N, et al. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. January 28, 2021;384(4):316-324.
    7 Kuniss M, Pavlovic N, Velagic V, et al. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. March 17, 2021:euab029.
    8 Andrade JG, Wells GA, Deyell MW, et al. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. January 28, 2021;384(4):305-315.
    9 Valembois L et al. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database of Systematic Reviews 2019, Issue 9. Art. No.: CD005049. DOI: 10.1002/14651858.CD005049.pub5.
     
    Related Searches
    • Surgical
    • Cardiovascular
    Related Knowledge Center
    • Surgical
    • Cardiovascular
    Suggested For You
    Northeast Biomedical Inc. Northeast Biomedical Inc.
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    sfm medical devices GmbH sfm medical devices GmbH
    Junkosha USA Inc. Junkosha USA Inc.
    Heraeus Medevio Heraeus Medevio
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021 MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    Boston Scientific Agrees to Acquire Devoro Medical Boston Scientific Agrees to Acquire Devoro Medical

    Related Buyers Guide Companies

    • Northeast Biomedical Inc.

      ...
      Timothy Looney, Northeast Biomedical, Inc. 11.18.22

    • JK Medirise-Disposable Medical Device Company

      ...
      Ketan Munjani, Marketing Manager 11.17.22

    • sfm medical devices GmbH

      ...
      Albert Busch, Head of Marketing 11.11.22


    • Junkosha USA Inc.

      Junkosha USA Inc.

      ...
      Andy Parker, Director 11.10.22

    • Heraeus Medevio

      Heraeus Medevio

      Heraeus is a globally active precious metals and technology Group with firm roots in Germany, headquartered in Hanau near Frankfurt.
      Megan Erd, Global Marketing Coordinator 11.02.22

    Loading, Please Wait..

    Trending
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    • A New Approach To Post-Market Surveillance
    • Tessy Plastics Corp. Celebrates 50th Anniversary
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    Breaking News
    • MPO's Most-Read Stories This Week—March 25
    • Getinge iCast Receives FDA Premarket Approval
    • Tessy Plastics Corp. Celebrates 50th Anniversary
    • Carium Expands Customization Options with Care Pathways
    • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    View Breaking News >
    CURRENT ISSUE

    March 2023

    • Sensing Technology Drives the Future of Medical Care
    • New and Developing Diabetes Technologies Offer 'Sweet Relief'
    • Discussing Matters of Substance in Medtech Materials
    • Medical Device Testers Are Caught Up in a Whirlwind
    • 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

    NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill
    GOOD Meat Receives FDA Go-Ahead for Cultured Meat
    IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain
    Coatings World

    Latest Breaking News From Coatings World

    HOFFMANN MINERAL to Focus on Comprehensive Sustainability Strategy
    HMG and Prodrive Renew Technical Partnership
    Eastern Coatings Show Sets Schedule for Technical Papers
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—March 25
    Getinge iCast Receives FDA Premarket Approval
    Tessy Plastics Corp. Celebrates 50th Anniversary
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Willow, Suanfarma Complete Manufacturing Process for Cannabigerol
    Berkshire Sterile to Install nearly 1,500 solar panels at Massachusetts site
    Harm Reduction Therapeutics, Catalent Ink Naloxone Commercial Supply Pact
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Interpack 2023 Introduces New Special Areas and Activities
    eSalon Expands into Over 1,900 CVS Stores Nationwide
    The RealReal Discontinues Beauty Business
    Happi

    Latest Breaking News From Happi

    ‘Glossier You’ Returns to Glossier’s Fragrance Portfolio
    Mielle Expands Pomegranate & Honey Collection with Debut of Air Dry Stylers
    Metallic Pigments Market Forecasted to Reach $3.4 Billion by 2033
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Packaging Inks, Toyo Ink Top This Week’s Stories
    Eastern Coatings Show Announces Schedule for Technical Papers
    Pulse Roll Label Products Adds Sean Labas to Technical Sales Team
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Imageworx details new facility, Avery Dennison tackles recycling and more
    TLMI announces 2022 Eugene Singer Award winners
    Pulse Roll Label Products expands technical sales team
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Heartland Polymers Begins Production, Zeta Polimeri Becomes Radici EcoMaterials & More
    Heartland Polymers Begins Production in Alberta
    Zeta Polimeri Becomes Radici EcoMaterials
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—March 25
    AI is Effective at Documenting Orthopedic Encounters in Hand Surgery
    3D LifePrints Rebrands to Insight Surgery & Launches New Business in Houston
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Dave Rahami, Zebra, Dracula Technologies Top This Week’s Stories
    Midsummer, UCLA Collaborate on Perovskite-CIGS Tandem Solar Cells
    HID Reports on Reshaping the Security Industry

    Copyright © 2023 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