• 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
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    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—June 3

    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA

    LifeQ Unveils New 24-Hour Sleep Solution

    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll

    EvoEndo Names CEO and Chief Operating Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    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
    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The

    JBC Technologies

    Fusion Biotec Inc.

    Providence Enterprise USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The

    JBC Technologies

    Fusion Biotec Inc.

    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

    Abbott’s MitraClip G4 Receives CE Mark

    Offers physicians an innovative system with more options for mitral valve repair using proven clip-based technology.

    Abbott’s MitraClip G4 Receives CE Mark
    The MitraClip system has been commercially available in the U.S. since 2013 and in Europe since 2008. Image courtesy of Abbott.
    Abbott09.21.20
    Abbott has received a CE Mark for its fourth-generation MitraClip Transcatheter Mitral Valve Repair System, a minimally invasive mitral valve repair device. The device is now approved for use in Europe and other countries that recognize CE Mark as a non-surgical option for the treatment of mitral regurgitation (MR), or a leaky heart valve. The device is already approved for use in the U.S.
     
    The MitraClip G4 system provides physicians in Europe with enhancements to MitraClip's clip-based technology, building upon the device's proven delivery system. In addition to offering advanced steering during implantation, the new delivery system offers four clip sizes, including two wider clips, for doctors to have a greater variety of treatment options that can be tailored to a patients' unique mitral valve anatomy.1 The newest-generation device also offers independently controlled grippers, if needed, that allow physicians to grasp one or both mitral valve leaflets at a time during the MitraClip procedure.
     
    Mitral Regurgitation
    MR is one of the most common heart conditions, affecting one in 10 adults age 75 and older.2,3 Patients with this progressive condition have a mitral valve that does not close completely, allowing blood to flow backward into the left atrium of the heart instead of forwards (out of the heart) and to the rest of the body. While medication can help people manage the symptoms of MR, it does not treat the leaky valve itself. Prior to MitraClip, open-heart surgery was the standard treatment for MR, however, not all patients are eligible or appropriate for open-heart surgery due to the potential risk of complications stemming from comorbidities, advanced age, or other issues.
     
    MitraClip is a minimally invasive transcatheter mitral valve repair (TMVr) therapy that can be a life-saving treatment option for select patients with primary or secondary MR.4 The small clip-based device is delivered to the heart through a vein in the leg and clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood. Once in place, MitraClip restores the proper functioning of the mitral valve and the heart's ability to pump oxygenated blood more efficiently.
     
    "Despite being consistently recognized as a problem in patients around the world, MR cannot be treated through the conventional method of open-heart mitral valve surgery in more than half of the people who have this condition," said Ralph Stephan Von Bardeleben, head of the Heart Valve Center Mainz, Universitätsmedizin Mainz, Germany, who treated the first MitraClip G4 patients in the EU. "The newest MitraClip therapy offers physicians a reliable option when surgical treatment of MR isn't possible or appropriate, and MitraClip G4's enhancements allow further customization of the therapy to tailor treatment to individual patient needs." 
     
    Clinical Studies of MitraClip
    MitraClip is backed by more than 16 years of clinical experience with proven safety, survival and durable clinical outcomes. Data presented at PCR e-Course this year from a real-world clinical study of over 1,000 MitraClip patients showed a high implant success rate (99%) and demonstrated MR reduction to the level of none or trace in patients with either primary MR (to ≤1+ in 87.1%) or secondary MR (to ≤1+ in 90.1%) at 30 days. This recent data confirms MitraClip's best-in-class MR reduction to date1 and adds to a body of evidence that demonstrates significant impact for patients, including improved clinical outcomes and quality of life.
     
    "An enduring measure of our mission to help people live better lives through better health is our success in advancing new standards of care for the treatment of structural heart diseases," said Michael Dale, senior vice president of Abbott's structural heart business. "This CE Mark, along with other recent approvals and advancements for our MitraClip device, underscores the need for MitraClip's innovative therapy – which has become a preferred choice for the treatment of mitral regurgitation around the world."
     
    References:
    1 Rottbauer W. D. Contemporary Clinical Outcomes with MitraClip™ (NTR/XTR) System: Core-lab Echo Results from +1000 Patient the Global EXPAND Study. Data presented at PCR 2020.
    2 Lloyd-Jones D, Adams RJ, Brown TM, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2010 update: a report from the American Heart Association. Circulation. 2010;121(7):e46-e215.
    3 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011.
    4 Primary MR is caused by an anatomic defect of one or more of the structures of the mitral valve of the heart, while secondary MR occurs in patients with coronary disease, wherein the damage from the disease impairs the performance of a normal mitral valve.
    Related Searches
    • Cardiovascular
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival
    Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech
    Paragonix Launches Global Registry for Studying Donor Lung Preservation Paragonix Launches Global Registry for Studying Donor Lung Preservation
    FDA Clears Inova Diagnostics FDA Clears Inova Diagnostics' Digital Multi-Analyte System
    Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    Quanta Raises $245 Million in Series D Funding Round Quanta Raises $245 Million in Series D Funding Round
    Thermo Fisher Scientific Launches Updated COVID-19 Test Thermo Fisher Scientific Launches Updated COVID-19 Test
    Roche to Acquire Long-Term Partner TIB Molbiol Roche to Acquire Long-Term Partner TIB Molbiol
    Luis J. Malavé Joins Integrity Applications Board Luis J. Malavé Joins Integrity Applications Board
    CE Mark Granted to Expandable, Biodegradable Biliary Stent CE Mark Granted to Expandable, Biodegradable Biliary Stent
    Roche Roche's COVID-19 Molecular Test Granted EUA
    SCIEX Debuts the ZenoTOF 7600 System SCIEX Debuts the ZenoTOF 7600 System
    Global Brain Computer Interface Market to Top $1.6B by 2028 Global Brain Computer Interface Market to Top $1.6B by 2028
    Abbott Buys Walk Vascular, a Thrombectomy System Maker Abbott Buys Walk Vascular, a Thrombectomy System Maker

    Related Breaking News

    • Turner Imaging Systems Announces International Expansion

      Turner Imaging Systems Announces International Expansion

      Company forges marketing agreement in the U.K. and Ireland.
      Business Wire 09.22.21

    • CE Mark Granted to Predictive Software for Kidney Allograft Survival

      CE Mark Granted to Predictive Software for Kidney Allograft Survival

      Algorithm gives the probability the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.
      Cibiltech 09.21.21

    • Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech

      Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech

      Electroducer Sleeve based on a medical technique called Direct Wire Pacing, which was invented by the company’s founder.
      Electroducer 09.21.21


    • Paragonix Launches Global Registry for Studying Donor Lung Preservation

      Paragonix Launches Global Registry for Studying Donor Lung Preservation

      Registry will capture data on how organ preservation and transportation impact patient outcomes in lung transplantation.
      Business Wire 09.20.21

    • Diagnostics
      FDA Clears Inova Diagnostics

      FDA Clears Inova Diagnostics' Digital Multi-Analyte System

      The product, Aptiva, received CE marking in August 2020.
      PR Newswire 09.20.21

    Loading, Please Wait..

    Trending
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • FDA Clears Sanara MedTech's Advanced Surgical Solution
    • Titan Medical Licenses Most IP To Intuitive; CEO Steps Down
    Breaking News
    • MPO's Most-Read Stories This Week—June 3
    • CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    • LifeQ Unveils New 24-Hour Sleep Solution
    • Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    • EvoEndo Names CEO and Chief Operating Officer
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • 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

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures and Carbios Reaffirm Partnership to Build PET Biorecycling Plant
    AkzoNobel Powder Coatings Enhances Digital Services with Launch of My Interpon Portal
    PPG Opens Color Creation Lab with Chery Automobile in China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—June 3
    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    LifeQ Unveils New 24-Hour Sleep Solution
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Terran Biosciences, Pierre Fabre Ink Exclusive Licensing Deal for Idazoxan
    ASM Research Chemicals Launches Development Packs for API Manufacturing
    WuXi Increases Manufacturing Capacity in Germany
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal North Asia President Discusses China's Consumer Sector Recovery & Premium Beauty Trends
    Kiehl’s Celebrates Pride by Supporting The Trevor Project
    L’Oréal & UNESCO Announce 2023 Laureates of the For Women in Science International Awards
    Happi

    Latest Breaking News From Happi

    An Eco-Friendly & Stylish PET Dropper for Cosmetic Products New from Epopack
    Color Street Celebrates Pride Month with Limited-Edition ‘Over the Rainbow’ Nail Strips
    Olay Rolls Out Sensitive Skin Line
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX Digital, hubergroup and HP Top This Week’s Stories
    Mactac Acquires Canadian Roll Label Distributor Label Supply
    WestRock Advances its Commitment to a Sustainable Future
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Schreiner's Pharma-Comb IL Label supports clinical trial cancer medication
    First Anytron ANY-JET III digital label press installed in Korea
    FPA announces Kasie Fairbarn as elected ELC co-chair
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Harper Hygienics Launches Hemp-Based Intimate Care Wipes
    What You’re Reading on Nonwovens-Industry.com
    Biodiapers Signs Agreement with Sicam
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 3
    Augmedics Debuts New Features, Indications for xvision Platform
    Artelon Closes $20M Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Francisco Melo, Smart Skis, onsemi Top This Week’s Stories
    DIC Acquires Photoresist Polymers Manufacturer PCAS Canada
    Arkema Collaborates with Habitat for Humanity Philadelphia

    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