• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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
    Cepheid, BioGX Partner to Create GeneXpert Monkeypox Test

    Siemens' Varian Gains FDA IDE Nod for FAST-02 Trial

    Acutus Medical Launches AcQCross Line Extension

    Accelmed Partners II, Lauxera Capital Partners Invest in Veranex

    Agnes Lee Named SVP of Investor Relations, Strategic Planning at Inogen
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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

    BMP Medical

    Arthur G. Russell Co. Inc., The

    Xact Wire EDM Corp.

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Investment in Health Startups Drops

    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques

    How MedTech Professionals Can Help Combat Physician Burnout

    How to Optimize Manufacturing Lines and Choose Which Machines to Buy
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    BMP Medical

    Arthur G. Russell Co. Inc., The

    Xact Wire EDM Corp.

    Fusion Biotec 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

    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.

    Related CONTENT
    • BMP Medical - Delivering Custom Plastics Manufactured Solutions
    • DDL Inc.
    • Hobson & Motzer Inc.
    • High Tech Turning Co. Inc.
    • Nissha Medical Technologies
    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
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    DDL Inc. DDL Inc.
    Hobson & Motzer Inc. Hobson & Motzer Inc.
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Nissha Medical Technologies Nissha Medical Technologies
    Northeast Biomedical, Inc. Northeast Biomedical, Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    Heraeus Medical Components Heraeus Medical Components
    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

    Related Videos

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    • 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 11.11.21

    • Hobson & Motzer Inc.

      Hobson & Motzer Inc.

      ...
      Anthony Bracale, Strategic Market Development Manager 11.03.21


    • High Tech Turning Co. Inc.

      ...
      Fred Sophis, Sales 11.02.21

    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 10.20.21

    Loading, Please Wait..

    Trending
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA OKs J&J Vision's AcuVue Oasys Max 1-Day Contact Lenses
    • How To Overcome The Top 6 Medical Device Manufacturing Challenges
    • Labcorp Launches At-Home Collection Device For Diabetes Risk Testing
    • Intermountain Healthcare & Siemens Healthineers Open 3 Tellica Outpatient Imaging Centers
    Breaking News
    • Cepheid, BioGX Partner to Create GeneXpert Monkeypox Test
    • Siemens' Varian Gains FDA IDE Nod for FAST-02 Trial
    • Acutus Medical Launches AcQCross Line Extension
    • Accelmed Partners II, Lauxera Capital Partners Invest in Veranex
    • Agnes Lee Named SVP of Investor Relations, Strategic Planning at Inogen
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise
    Shiitake Mushroom Extract Appears Helpful in HPV Infections
    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    Coatings World

    Latest Breaking News From Coatings World

    H.M. Royal Becomes Exclusive OCSiAl Distributor
    American Colors to Expand Sandusky, Ohio Facility
    Vaughn O’Dea Named Director of Epoxytec
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Cepheid, BioGX Partner to Create GeneXpert Monkeypox Test
    Siemens' Varian Gains FDA IDE Nod for FAST-02 Trial
    Acutus Medical Launches AcQCross Line Extension
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate
    Pfizer, BioNTech Adapt COVID Vax Against Omicron
    CoreRx Expands Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Top 5 Beauty Tech Trends at Perfect Corp.'s Global Forum
    John Frieda Supports the LGBTQIA+ Community
    Athena Club Launches in Canada
    Happi

    Latest Breaking News From Happi

    Fencing Champion Bebe Vio Grandis Named Spokeswoman of L’Oréal Paris
    Past Henkel Exec Christian Chopra Named President of Scotch Porter
    Color Street Celebrates Foster, Adoption Awareness with Limited-Edition Print
    Ink World

    Latest Breaking News From Ink World

    Dr. Tammo Boinowitz to Join Management Board of ALTANA AG
    Flint Offset Packaging Solutions Announces Price Increases for Sheetfed Inks
    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Harveer Sahni recognized with Global Achievement Award
    Color-Logic partners with Taktiful 
    ALTANA announces Management Board change
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Fibertex Personal Care Awarded EcoVadis Awards for Sustainability
    Yanpai Orders Batt Forming Equipment for Needlepunch Line
    Weekly Recap: SWM and Neenah Introduce Mativ Inc., Avgol honored for Biotransformation Technology & More
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Researchers Discover Novel Patching Material for Bone Defects
    Boston Centerless Opens Second Manufacturing Plant in Indiana
    Researchers Develop Patient-Specific 3D-Printed Smart Metamaterial Implants
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv-Powered CVS Spoken Rx Wins NFC Forum 2022 Innovation Award
    LG Display Announces Winners of This Year’s OLEDs GO! Competition
    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories

    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