• 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
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    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
    Tessy Plastics Names Stafford Frearson as President

    HoneyNaps' AI Sleep Disorder Diagnosis Software Earns FDA Nod

    Biomerics Finishes Expansion of Minnesota Facility

    MPO's Most-Read Stories This Week—Sept. 23

    Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Medtech’s Most Powerful M&A Drivers

    The Link Between Medtech and Connected Medical Devices

    Is the FTC Partly Responsible for Muted M&A Activity?

    Holistic Risk Management: Navigating the Future’s Uncertainties

    Defining End of Life for Medical Devices
    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

    Cirtec Medical

    Providence Enterprise USA Inc.

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing

    How In Silico Simulations Can Slash Medical Device Development Risk

    The Top 7 AI Applications Transforming Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    JBC Technologies

    Cirtec Medical

    Providence Enterprise USA Inc.

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The
    • 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

    Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

    Will evaluate PulseSelect's pulsed electrical fields to interrupt irregular heart rhythms.

    Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib
    Sam Brusco, Associate Editor03.04.21
    Medtronic completed the first procedures in the investigational device exemption (IDE) pivotal trial to evaluate the PulseSelect Pulsed Field Ablation (PFA) System, which uses pulsed electric fields to treat atrial fibrillation (AF). The first procedure in the PULSED AF pivotal trial was performed this week at Southcoast Health by Nitesh Sood, M.D., Fall River, Massachusetts; the second procedure was performed by Arnoldas Giedrimas, M.D., also at Southcoast Health.
     
    The PulseSelect System delivers pulsed electric fields through an ablation catheter that interrupts irregular electrical pathways in the heart that trigger AF. Unlike traditional ablation methods that heat or cool the atrial tissue, PulseSelect uses a non-thermal approach and preferentially targets heart tissue to avoid unwanted injury to surrounding structures.
     
    "Based on the results we've experienced with the pilot trial, we are entering a new era for AF ablation techniques with this novel energy source," Atul Verma, M.D., electrophysiologist and head of arrhythmia services at Southlake Regional Health Centre in Newmarket, Canada and the principal investigator (PI) for the PULSED AF study told the press. "We are excited to begin the pivotal stage of the PULSED AF study and generate a larger body of clinical evidence to support the safety and benefits of pulsed field ablation."
     
    The PULSED AF trial will enroll up to 500 patients who will be treated with the PulseSelect System across 50 sites in the U.S., Canada, Europe, and Australia. The trial will evaluate the PulseSelect System’s safety and efficacy in treating AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF. Patients will be assessed at six and 12 months.
     
    "For years, Medtronic has been an active leader in the investigation of the safety and efficacy of pulsed field ablation," said Rob Kowal, M.D., Ph.D., chief medical officer of Cardiac Ablation Solutions, part of the Cardiac and Vascular Group at Medtronic. "Developed internally at Medtronic, the PulseSelect System has the potential to create a paradigm shift in how cardiac ablations are performed for patients suffering from atrial fibrillation."
     
    PulseSelect pre-clinical research included extensive work to understand the novel energy source’s physiology and mechanism of action, resulting in Breakthrough Device Designation in 2018 from the U.S. Food and Drug Administration (FDA) to treat drug refractory recurrent symptomatic AF.
     
    Results of the PULSED AF pilot study were presented in a late-breaking session at Heart Rhythm Society 2020 Science and additional evidence was shared at the AF Symposium in January 2021, demonstrating 100 percent acute efficacy and no device or procedural-related events in the pilot cohort of patients. Worldwide, the PulseSelect system is investigational and not approved for sale or distribution.
    Related Searches
    • Cardiovascular
    Related Knowledge Center
    • 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
    • A New Approach To Post-Market Surveillance
    • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • Cochlear Implant Study Underway At Mayo Clinic
    • MPO's Most-Read Stories This Week—Sept. 16
    Breaking News
    • Sherri Ferstler Joins Tactile Medical as Senior Sales VP
    • Tessy Plastics Names Stafford Frearson as President
    • HoneyNaps' AI Sleep Disorder Diagnosis Software Earns FDA Nod
    • Biomerics Finishes Expansion of Minnesota Facility
    • MPO's Most-Read Stories This Week—Sept. 23
    View Breaking News >
    CURRENT ISSUE

    September 2023

    • Superior Subtractive Solutions for Machining Medtech
    • Medical Device Industry Experts' Thought on Assembly & Automation
    • Power Trip: A Discussion of Custom Medical Electronics
    • The MDR Transition: An Opportunity for Design Change?
    • 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

    GOED Releases Sustainability Report for Omega-3s Industry
    ABC’s Journal HerbalGram Celebrates 40th Anniversary
    Curcumin May Be As Effective as PPI for Indigestion
    Coatings World

    Latest Breaking News From Coatings World

    Śnieżka Group Results are Above Expectations in 1H 2023
    ACS Reports Chameleon Inspired Building Coating
    Substrate Wetting Agent Available from BRB International
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—Sept. 23
    Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    FDA Clears MeMed BV Direct From Whole Blood
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Eftilagimod Cleared for Clinical Trial Use in the UK
    Veranova Names William Sanders Global VP of Chemical Development Ops
    Chime, Panolos Partner to Advance Multi-specific Therapeutic Proteins
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L’Oréal Invests in Chinese Biotech Company ‘Shinehigh Innovation’
    Investindustrial to Acquire 51% Share of Virospack
    Weekly Recap: J&J Updates Visual Identity, L’Oréal Makes Executive Changes & More
    Happi

    Latest Breaking News From Happi

    SC Johnson’s Guardian Spatial Mosquito Repellent Tool Hits Milestone in Field Testing
    Ulta Beauty’s The Joy Project Address Everyone’s Struggle with Negative Self-Talk
    Natural Products Expo East Tradeshow Closes
    Ink World

    Latest Breaking News From Ink World

    Cooper Watson Acquires Tower Products
    The Durst Group Awarded Eight 2023 PRINTING United Alliance Pinnacle Awards
    Weekly Recap: Wikoff Color, HP, INX VC Top This Week’s Stories
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PRX Market debuts, Tower Products acquired and more
    Flexo Wash to exhibit at FTA Fall Technical Conference
    Recyclable, deinkable stand-up pouch wins Gold in Germany
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Soft N' Dry Seeks to Expand Private Label Roll Out, Albis Completes Work on Line
    Lenzing Earns EU Ecolabel at Indonesian Plant
    Albis Completes Work On Extra Wide Carding, Blending Line
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    LimaCorporate to Be Sold to Enovis
    ODT's Most-Read Stories This Week—Sept. 23
    Anika Releases RevoMotion Reverse Shoulder Arthroplasty System
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    HID to Showcase Future-Proof Solutions at GITEX 2023
    Weekly Recap: Mergers and Acquisitions, IEC’s IME Standards Top This Week’s Stories
    EU-Funded Collaboration Hub Aims to Mainstream Printed Electronics

    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