• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Top News
    FineHeart Successfully Tests Wireless TET System

    Apria Healthcare Settles Whistleblower Lawsuit

    OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment

    Remote Patient Monitoring Market Set to Surpass $645 Million by 2025

    4C Medical Technologies Completes $10 Million Over-Subscribed Convertible Note Financing
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    maxon

    Qosina Corp.

    Unicep

    Spectrum Plastics Group

    MW Life Sciences
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Concise Engineering

    Spectrum Plastics Group

    Creganna Medical, part of TE Connectivity

    Unicep

    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
    • Podcasts
    • Resources
    • eBook
    • 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 Cryoablation Outperforms Drug Therapy for Symptomatic Paroxysmal AFib

    New research highlights first-line use of cryoablation as highly effective, and with improved quality of life scores.

    Related CONTENT
    • Katena Products Welcomes New CEO
    • Medtronic’s Mike Coyle to Lead iRhythm
    • Medtronic's OsteoCool Procedure Shows Significant Pain Relief in Cancer Patients
    • Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine
    • Six Percent Growth Predicted for APAC Neurovascular Thrombectomy Devices Market
    GlobeNewswire08.31.20
    Medtronic plc announced clinical trial results demonstrating superiority of the Arctic Front Advance Cardiac Cryoballoon and Freezor MAX Cardiac CryoAblation Catheter for the first-line treatment (prior to drug therapy) of recurrent symptomatic paroxysmal atrial fibrillation (PAF) compared to antiarrhythmic drug (AAD) treatment. Primary results of the randomized STOP AF First trial were presented as a late breaking clinical trial at the European Society of Cardiology (ESC) Congress 2020 Digital Experience. Additionally, 12-month outcomes from the Cryo-FIRST trial showed a significant improvement in atrial fibrillation-related quality of life with the use of the Medtronic cryoablation system compared to anti-arrhythmic drug therapy in patients who had not previously received antiarrhythmic drugs to treat their symptomatic PAF.
     
    Atrial fibrillation (AF) is a progressive condition that impacts more than 33 million people worldwide.1 Without early intervention, progression of the condition is associated with a higher rate of cardiovascular admissions,2 heart failure hospitalization,3 and mortality,4 along with a reduced quality of life.5 Antiarrhythmic drug therapy is currently the standard first-line treatment for patients with AF; however, AF recurs in approximately 50 percent of patients treated with AADs within a year of therapy onset. In addition, AAD therapy frequently causes side effects that can lead many patients to discontinue treatment.6 Cryoablation uses cold energy (freezing) delivered through an inflatable balloon to create scar tissue to interrupt unwanted electrical pathways in the heart.
     
    STOP-AF First Primary Results
    The STOP-AF First trial enrolled 225 patients at 24 sites in the United States and was designed to evaluate the safety and effectiveness of the Medtronic cryoablation system to treat recurrent symptomatic PAF in patients who had not previously received antiarrhythmic drugs for their AF. A total of 203 patients randomized to cryoablation (104 in treatment arm) or AAD therapy (99 in control arm) received treatment and were followed for 12 months.
     
    Results showed superiority of cryoablation for maintaining freedom from AF, atrial tachycardia and atrial flutter, with treatment success achieved in 75 percent of patients in the catheter ablation group versus 45 percent in the AAD group (P<0.0001). Furthermore, the trial revealed a low rate of safety events with catheter ablation as a first-line therapy (1.9 percent). Previous studies have consistently demonstrated a low rate of serious complications with cryoablation in drug refractory patients; the STOP AF First study furthers these observations specifically to patients who had not previously received antiarrhythmic drugs to treat their symptomatic PAF.7,8
     
    Cryo-FIRST Quality of Life Results 
    Cryo-FIRST was a randomized, multicenter trial that enrolled 220 patients at 18 sites in nine countries across Europe, Australia and Latin America. Similar to STOP AF First, this trial found that the Medtronic cryoablation system is superior to AAD therapy for the prevention of atrial arrhythmia recurrence in PAF patients who have not previously been treated with drug therapy.
     
    New quality of life findings from the trial, also presented at ESC 2020, showed the Medtronic cryoablation solution resulted in a significant improvement in AF-specific, health-related quality of life at 12 months compared to AAD therapy.
     
    “More than half of patients with symptomatic AF do not experience a reduction in AF with antiarrhythmic drugs, effectively delaying their therapy and leaving a critical need for an alternative first-line treatment,” said Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm and Heart Failure and the Cardiac Ablation Solutions divisions, which are part of the Cardiac and Vascular Group at Medtronic. “Not only do the STOP AF First findings show cryoablation is a potential first-line treatment for these patients, the Cryo-FIRST results show encouraging benefits of this treatment approach on these patients’ quality of life.”
     
    The Arctic Front Advance Cryoablation System is approved in Europe for the treatment of AF. The United States Food and Drug Administration (FDA) recently expanded the indication for Medtronic cryoablation therapy to include treating patients with symptomatic, recurrent persistent AF, in addition to patients with drug refractory, recurrent, symptomatic paroxysmal AF. Results of the STOP-AF First trial have not been reviewed by the FDA.
     
    “The strong evidence from these trials will help bring cryoablation treatment to more patients suffering from AF earlier in the course of their disease,” said Rebecca Seidel, vice president and general manager of Cardiac Ablation Solutions. “Medtronic has very robust clinical evidence supporting the Arctic Front Family of Cardiac Catheters as a first line therapy for paroxysmal AF, and for paroxysmal and persistent AF patients whose condition is unresponsive to drug therapy.”
     
    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 that deliver clinical and economic value to healthcare consumers and providers around the world.

    References
    1 Chugh S, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014; 129:837-847.
    2 de Vos CB et al. rogression from paroxysmal to persistent atrial fibrillation clinical correlates and prognosis. J Am Coll Cardiol. 2010;55(8):725-731.
    3 Wong JA et al. Progression of Device-Detected Subclinical Atrial Fibrillation and the Risk of Heart Failure. J Am Coll Cardiol. 2018;71(23):2603-2611.
    4 Piccini JP et al. Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices. Europace. 2019;21(3):404-413.
    5 Dudink E et al. The influence of progression of atrial fibrillation on quality of life: a report from the Euro Heart Survey, EP Europace, Volume 20, Issue 6, June 2018, Pages 929–934
    6 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.
    7 Knight BP, Novak PG, Sangrigoli R, et al.; STOP AF PAS Investigators. Long-Term Outcomes After Ablation for Paroxysmal Atrial Fibrillation Using the Second-Generation Cryoballoon: Final Results From STOP AF Post-Approval Study. JACC Clin Electrophysiol. 2019; 5(3): 306-314.
    8 Hoffmann E, Straube F, Wegscheider K, et al. Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation. Europace 2019;21:1313-24.
    Related Searches
    • Cardiovascular
    • Surgical
    Related Knowledge Center
    • Cardiovascular
    • Surgical
    Suggested For You
    Medtech Matters: Medtronic Medtech Matters: Medtronic's Robotic Surgery Status
    Katena Products Welcomes New CEO Katena Products Welcomes New CEO
    Medtronic’s Mike Coyle to Lead iRhythm Medtronic’s Mike Coyle to Lead iRhythm
    Medtronic Medtronic's OsteoCool Procedure Shows Significant Pain Relief in Cancer Patients
    Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine
    Six Percent Growth Predicted for APAC Neurovascular Thrombectomy Devices Market Six Percent Growth Predicted for APAC Neurovascular Thrombectomy Devices Market
    Thirteen Percent Revenue Shortfall Expected in Capsule Endoscopes Market Thirteen Percent Revenue Shortfall Expected in Capsule Endoscopes Market
    Global Neurovascular Devices Market to Surpass $3.18 Billion by 2027 Global Neurovascular Devices Market to Surpass $3.18 Billion by 2027
    Medtronic Launches InPen with Real-Time Guardian Connect CGM Data Medtronic Launches InPen with Real-Time Guardian Connect CGM Data
    The Lost Year: 2020 Year in Review The Lost Year: 2020 Year in Review
    The Heart of the Matter: Trends in Cardiology The Heart of the Matter: Trends in Cardiology
    The Top 30 and M&A in 2021: What’s Next? The Top 30 and M&A in 2021: What’s Next?
    Former Medtronic, St. Jude Executive Assumes CCO Role at JenaValve Former Medtronic, St. Jude Executive Assumes CCO Role at JenaValve
    FDA Approves Boston Scientific FDA Approves Boston Scientific's Ranger Drug-Coated Balloon
    Pandemic to Reduce Global Robotic Surgery Systems Market Revenue by Nearly 8 Percent Pandemic to Reduce Global Robotic Surgery Systems Market Revenue by Nearly 8 Percent

    Related Breaking News

    • Cardiovascular
      FineHeart Successfully Tests Wireless TET System

      FineHeart Successfully Tests Wireless TET System

      A breakthrough in treating patients with severe heart failure.
      FineHeart 01.18.21

    • Cardiovascular
      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      The use of TAVR over open surgical techniques for replacing an aortic valve has exploded globally in recent years.
      GlobalData 01.15.21

    • Surgical
      Moon Surgical Expands Leadership Team

      Moon Surgical Expands Leadership Team

      Adds Jeffery Alvarez, David Noonan, and Nicolas Linard.
      Moon Surgical 01.14.21


    • Cardiovascular
      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      Company adds to portfolio of 40 patents for catheter-based technology that leverages the power of the body’s natural fluid removal process.
      Business Wire 01.13.21

    • Neurological | Surgical
      FDA OKs ClearMind Biomedical

      FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

      Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.
      PR Newswire 01.12.21

    • Cardiovascular
      Acutus Medical Launches AcQCross Transseptal System in Europe

      Acutus Medical Launches AcQCross Transseptal System in Europe

      The product is designed to improve safety and efficiency in any procedure requiring left heart access.
      Globe Newswire 01.08.21


    • Packaging & Sterilization | Surgical
      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      HEPA hinged door endoscope storage system addresses infection prevention needs in busy GI suites.
      Olympus 01.06.21

    • Surgical
      FDA Clears EndoRotor to Remove Dead Pancreatic Tissue

      FDA Clears EndoRotor to Remove Dead Pancreatic Tissue

      Treats patients with necrotic tissue resulting from complications of acute pancreatitis.
      U.S. Food and Drug Administration 01.04.21

    • Cardiovascular | Neurological | Surgical
      FDA OKs Rapid Medical

      FDA OKs Rapid Medical's Steerable Neurovascular Guidewire

      Provides efficient access in difficult neuro and peripheral vascular procedures.
      Business Wire 01.04.21


    • Cardiovascular
      Edwards Treats First Patient in Restore Clinical Trial

      Edwards Treats First Patient in Restore Clinical Trial

      Evaluates minimally invasive device for mitral valve disease.
      Edwards Lifesciences Corp. 12.21.20

    • Cardiovascular | Diagnostics
      Genetesis

      Genetesis' CardioFlux Imaging Tech Gains Breakthrough Status

      Leverages room temperature magnetometers to noninvasively measure heart’s naturally-generated magnetic fields.
      Business Wire 12.16.20

    • Cardiovascular
      Pandemic May Hinder Growth in Peripheral Drug-Coated Balloon Market

      Pandemic May Hinder Growth in Peripheral Drug-Coated Balloon Market

      Percutaneous transluminal angioplasty balloon procedures declined by almost 30 percent in 2020.
      GlobalData 12.15.20


    • Surgical
      Clinical Trial to Study Impact of ActivePure Technology on Surgical Site Infections

      Clinical Trial to Study Impact of ActivePure Technology on Surgical Site Infections

      The study will use 50 noncardiac, adult operating rooms at Cleveland Clinic.
      Aerus Medical 12.14.20

    • Cardiovascular | Surgical
      Foldax Earns FDA Approval for Biopolymer Mitral Heart Valve Study

      Foldax Earns FDA Approval for Biopolymer Mitral Heart Valve Study

      Valve designs intended to resist calcification, withstand stresses and strains without failure.
      Business Wire 12.14.20

    • Cardiovascular
      Innovative Health Obtains Patent for Microlumen Reprocessing Technology

      Innovative Health Obtains Patent for Microlumen Reprocessing Technology

      Paves the way for future innovation in the field by the company.
      Innovative Health Inc. 12.11.20


    Trending
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • FineHeart Successfully Tests Wireless TET System
    • Apria Healthcare Settles Whistleblower Lawsuit
    • OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment
    • Remote Patient Monitoring Market Set to Surpass $645 Million by 2025
    • 4C Medical Technologies Completes $10 Million Over-Subscribed Convertible Note Financing
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    Cistanche Tubulosa Botanical Shown to Attenuate Locomotive Syndrome
    Maternal Dietary Intake of Fish, Omega-3s, and Omega-6s Linked to Child Neurodevelopment
    Short Term Low-Carb Diet Linked to Remission of Type 2 Diabetes
    Coatings World

    Latest Breaking News From Coatings World

    Huntsman Finalizes Acquisition of Gabriel Performance Products
    PPG Completes COLORFUL COMMUNITIES Project at School in A. Bangsaothong Samutprakarn, Thailand
    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FineHeart Successfully Tests Wireless TET System
    Apria Healthcare Settles Whistleblower Lawsuit
    OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Valeo Pharma Appoints President, COO
    Metrion, LifeArc Extend Neuroscience Alliance
    Grifols Begins COVID-19 Plasma Treatment Trial
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    JLo Beauty Launches at Sephora & Amazon
    Unilever and Alibaba Group Join Forces
    Redken Unveils Acidic Bonding Concentrate Range
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    Manscaped Expands Further in Europe
    Color Street Gives Back
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Super Strong Inks Survive Tough Environments
    Ontex Honored for Mask Production
    TFP Acquires PV3 Technologies
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OrthoPediatrics Expands Agent Network in Three European Countries
    Studies Show FlareHawk Expandable Cage Delivers Favorable Fusion, Patient Outcomes
    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    Copyright © 2021 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