• 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
    Butterfly Network Appoints New Leader

    BD Names Chairman of Board

    Interplex Acquires OCP Group

    FDA Clears a Portable Hemodialysis System

    Solid Growth Forecast for India's HER2 Amplification Tests Market
    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
    Creganna Medical, part of TE Connectivity

    Concise Engineering

    Spectrum Plastics Group

    FUTEK Advanced Sensor Technology Inc.

    Medicoil
    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
    Medbio LLC

    Medicoil

    K-Tube Technologies

    Qosina Corp.

    Element
    • 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

    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.
    Related CONTENT
    • QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    • High-Volume COVID Antigen Test Receives FDA EUA
    • Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA
    • Acutus Medical Launches AcQCross Transseptal System in Europe
    • Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe
    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
    QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    High-Volume COVID Antigen Test Receives FDA EUA High-Volume COVID Antigen Test Receives FDA EUA
    Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA
    Acutus Medical Launches AcQCross Transseptal System in Europe Acutus Medical Launches AcQCross Transseptal System in Europe
    Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe
    EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit
    Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval
    FDA, EU Nods for POC Testing on Siemens Healthineers FDA, EU Nods for POC Testing on Siemens Healthineers' epoc NXS Host Mobile Computer
    Sofwave Medical Granted CE Mark for Skin Tightening, Wrinkle Reduction Device Sofwave Medical Granted CE Mark for Skin Tightening, Wrinkle Reduction Device
    Shimmer Research Receives CE Certification for Inertial Measurement Unit Sensor Shimmer Research Receives CE Certification for Inertial Measurement Unit Sensor
    CE Mark Granted for Automated Glycemic Control and Continuous Diagnostics System CE Mark Granted for Automated Glycemic Control and Continuous Diagnostics System
    FDA OKs Hologic FDA OKs Hologic's Aptima HIV-1 Quant Dx Assay for HIV Diagnosis
    Global Neurovascular Devices Market to Surpass $3.18 Billion by 2027 Global Neurovascular Devices Market to Surpass $3.18 Billion by 2027
    First Patients Treated With Pulsed Electric Field Cardiac Ablation System First Patients Treated With Pulsed Electric Field Cardiac Ablation System
    Vygon, Oncomfort Partner to Commercialize Virtual Reality Pain Relief Device Vygon, Oncomfort Partner to Commercialize Virtual Reality Pain Relief Device

    Related Breaking News

    • Cardiovascular
      Alleviant

      Alleviant's Transcatheter Tech Obtains Breakthrough Status

      The technology offers a no-implant interatrial shunt therapy for heart failure patients.
      Sam Brusco, Associate Editor 01.25.21

    • Cardiovascular
      First Heart Failure Patient Treated With Impulse Dynamics

      First Heart Failure Patient Treated With Impulse Dynamics' CCM Therapy in Brazil

      The Optimizer delivers cardiac contractility modulation therapy, the company’s proprietary technology, to the heart.
      Business Wire 01.21.21

    • Cardiovascular
      Boston Scientific to Acquire Preventice for Up to $925M

      Boston Scientific to Acquire Preventice for Up to $925M

      Acquisition of external cardiac monitoring technologies, services provider to expand rhythm management diagnostics portfolio.
      PR Newswire 01.21.21


    • Cardiovascular | Surgical
      Haemonetics to Acquire Cardiva for Up to $510M

      Haemonetics to Acquire Cardiva for Up to $510M

      Enhances penetration into the large and growing interventional cardiology and electrophysiology markets.
      PR Newswire 01.20.21

    • Cardiovascular | Surgical
      Abbott Wins Expanded Medicare Coverage for MitraClip

      Abbott Wins Expanded Medicare Coverage for MitraClip

      Includes patients with secondary (or functional) mitral regurgitation resulting from heart failure.
      Abbott Laboratories 01.20.21

    • Cardiovascular | Patient Monitoring
      Hillrom to Buy Bardy Diagnostics for $375M

      Hillrom to Buy Bardy Diagnostics for $375M

      Advances digital health offering with expansion into attractive ambulatory cardiac monitoring segment.
      PR Newswire 01.19.21


    • Cardiovascular
      Occlutech

      Occlutech's Atrial Flow Regulator Earns Breakthrough Status for HF

      First-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients.
      PR Newswire 01.19.21

    • Cardiovascular | Diagnostics
      FDA OKs MRI for Impulse Dynamics

      FDA OKs MRI for Impulse Dynamics' Optimizer CCM Delivery Systems

      FDA clears potential hurdle for many heart failure patients.
      Business Wire 01.19.21

    • 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

    • 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

    • 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


    • 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


    Trending
    • Senseonics Forges Strategic Collaboration With Ascensia Diabetes Care
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Top 10 Trends In The Medical Device And Equipment Industry
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Breaking News
    • Butterfly Network Appoints New Leader
    • BD Names Chairman of Board
    • Interplex Acquires OCP Group
    • FDA Clears a Portable Hemodialysis System
    • Solid Growth Forecast for India's HER2 Amplification Tests Market
    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

    Kerry Launches Web-Based Tool for Plant-Based Formulation Challenges
    Wiley’s Finest Earns Accolades for Taste of Omega-3 Products
    Clinical Evidence Suggests Potential Oral Benefits for Curcumin Extract
    Coatings World

    Latest Breaking News From Coatings World

    Scott McLaughlin to Race in PPG Colors During Rookie INDYCAR Season
    Vink Chemicals Offers parmetol PSG
    Minwax Announces Vintage Blue as 2021 Color of the Year
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Butterfly Network Appoints New Leader
    BD Names Chairman of Board
    Interplex Acquires OCP Group
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Stevanato Group Launches After-sales Service Offering
    X-Chem Acquires IntelliSyn and AviSyn
    Aphena’s $21M Cookeville Expansion Nears Completion
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Estée Lauder Companies Announces Game-Changing Sustainability Goals for Travel Retail
    Aura Introduces Customizable Hair Care
    Corpack Creates Custom Packaging for Marlies Möller Hair Care Line
    Happi

    Latest Breaking News From Happi

    Harry’s Launches ‘Headquarters’
    Nice-Pak Receives EPA Approval for Disinfectant Wipes
    Henkel Recognizes Top Suppliers
    Ink World

    Latest Breaking News From Ink World

    Smurfit Kappa Sets New Sustainability Targets with Better Planet 2050
    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    Rondo Ganahl Adds Koenig & Bauer Durst Delta SPC 130
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Great Lakes Label debuts new website
    Epson partner creates label applicators for pharmaceutical products
    ACTEGA removes chemicals from laminating adhesives
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    American Made Production Equipment for Mask Manufacturers
    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Spinal Elements' Lucent XP-Curved Expandable TLIF Gains FDA Nod
    FDA OKs OrthoSpin's 2nd Gen Robotic, Digital External Fixation System
    Nextremity Solutions Enters Supply Agreement with Fort Wayne Metals
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    North American Semiconductor Equipment Industry Posts December 2020 Billings
    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    PRINTING United Alliance Announces TAGA Presents Virtual Event

    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