• 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
    JBC Technologies

    Forefront Medical Technology

    Fusion Biotec Inc.

    Cirtec Medical

    Medbio LLC
    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
    JBC Technologies

    Forefront Medical Technology

    Fusion Biotec Inc.

    Cirtec Medical

    Medbio LLC
    • 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

    FDA Approves AtriCure's EPi-Sense System for Persistent Afib

    Trial showed a 29 percent difference in effectiveness at 12 months, a 35 percent difference in effectiveness at 18 months for long-standing persistent Afib.

    Business Wire06.29.21
    AtriCure Inc., an innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, has received U.S. Food and Drug Administration (FDA) approval of the EPi-Sense System to treat patients diagnosed with long-standing persistent Afib. The CONVERGE trial demonstrated superiority in the hybrid AF therapy arm compared to endocardial catheter ablation alone. In patients diagnosed with long-standing persistent Afib, the hybrid therapy arm showed a 29 percent absolute difference in efficacy at 12-months (78 percent relative improvement) and an absolute difference of 35 percent at 18 months (110 percent relative improvement). There was also a 33 percent absolute difference in Afib burden reduction in favor of the hybrid AF therapy at 12 months, which increased to 37 percent at 18 months.
     
    “FDA approval is a monumental step forward in the market focused on patients with the most advanced and difficult to treat Afib,” said Michael Carrel, president and CEO at AtriCure. “The long-standing persistent Afib population represents over three million patients in the United States alone, or nearly half of all diagnosed Afib patients. This approval will enable us to educate and train physicians across the country on the benefits of hybrid AF therapy in treating long-standing persistent Afib patients. In addition to superior clinical results, the procedure significantly improves electrophysiology lab efficiency by reducing endocardial ablation times by over 40 minutes, improving throughput and enabling more patients to be treated.”
     
    “This therapy should help change the standard of care and improve the lives of millions of patients. Due to less than optimal outcomes with endocardial ablation alone, many patients in whom Afib has progressed are not even considered for ablation treatment today. The high-quality evidence from the CONVERGE trial should encourage cardiologists, electrophysiologists and surgeons, as a team, to consider this procedure for these patients,” said David DeLurgio, M.D., director of Electrophysiology at Emory St. Joseph’s Hospital, and the trial’s global principal investigator. “The improvement using the EPi-Sense System for posterior left atrial wall and pulmonary vein ablation, in combination with an endocardial catheter to address lesion gaps, is truly remarkable. Additionally, Afib burden reduction results are especially encouraging as they mirror our experience as well as peer reviewed published data outside of the trial.”
     
    Afib affects more than 33 million people worldwide and approximately 45 percent of those people have long-standing persistent Afib.1 Afib increases the risk of stroke and is linked with increased risk of mortality. The number of people with Afib is expected to increase significantly over the next decade.
     
    “Hybrid AF therapy is the only FDA-approved minimally invasive ablation procedure to treat patients who have been in continuous Afib for more than one year, which is a large number of my patients,” said Hugh Calkins, M.D., director of the Arrhythmia Service and the Clinical Electrophysiology Lab at Johns Hopkins University. “These patients with advanced Afib are very difficult to treat with catheter ablation alone. The data from the CONVERGE trial is compelling, and patients will benefit greatly from having this treatment.”
     
    Data from the CONVERGE trial at 18 months has shown that hybrid AF therapy provides durable, sustained efficacy. In the treatment arm, freedom from all arrhythmias in the long-standing persistent population was 61 percent, versus 26 percent for endocardial catheter ablation alone. Freedom from Afib alone at 18-months was 68 percent for hybrid AF therapy, versus 30 percent in the catheter ablation arm for the same group of patients.
     
    “These 18-month results are incredible and demonstrate the durability of the procedure,” said Dr. DeLurgio. “This is a key finding from the trial and shows that patients who undergo a hybrid procedure should expect continued freedom from Afib. I’m really looking forward to seeing this therapy expand and impact more patients who have no other effective treatment options.”
     
    The CONVERGE trial was a landmark prospective, superiority, randomized controlled pivotal trial to evaluate the overall success of hybrid ablation compared to endocardial catheter ablation alone for patients with persistent or long-standing persistent Afib. The procedure combines a minimally invasive, closed chest epicardial ablation performed by a surgeon using the AtriCure EPi-Sense System with endocardial radiofrequency catheter ablation performed by an electrophysiologist. The trial enrolled 153 patients at 27 locations (25 in the United States and 2 in the United Kingdom). Patients were randomized at a rate of 2:1 and received either the hybrid procedure or an endocardial catheter ablation alone.
     
    AtriCure Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. 

    Reference 
    1 Berisso et al. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014; 6: 213–220.
    Related Searches
    • Cardiovascular
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Northeast Biomedical Inc. Northeast Biomedical Inc.
    Nissha Medical Technologies Nissha Medical Technologies
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    DDL Inc. DDL Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    Junkosha USA Inc. Junkosha USA Inc.
    Heraeus Medevio Heraeus Medevio
    Hobson & Motzer Inc. Hobson & Motzer Inc.
    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

    Related Buyers Guide Companies

    • Northeast Biomedical Inc.

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

    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 11.18.22

    • JK Medirise-Disposable Medical Device Company

      ...
      Ketan Munjani, Marketing Manager 11.17.22


    • DDL Inc.

      DDL Inc.

      DDL has been in medical device package, product and material testing industry for almost 20 years. We strive to offer the most effective business practices while employing a staff of technical experts.
      Chris Murphy, Marketing Manager 11.11.22

    • sfm medical devices GmbH

      ...
      Albert Busch, Head of Marketing 11.11.22

    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