• 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
    Intersect ENT Announces CMS Approval of Coding Application for Sinus Implant

    Hillrom to Buy Bardy Diagnostics for $375M

    Global Tissue and Organ Transplantation Market to Surpass $25.6 Billion by 2027

    Owlstone Medical Introduces Breath Biopsy Panel for Respiratory Diseases

    Cognoptix Forms a New Board of Directors
    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
    K-Tube Technologies

    PTI Engineered Plastics Inc.

    Qosina Corp.

    Element

    FUTEK Advanced Sensor Technology Inc.
    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
    Medicoil

    K-Tube Technologies

    FUTEK Advanced Sensor Technology Inc.

    Creganna Medical, part of TE Connectivity

    Spectrum Plastics Group
    • 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 Gains CE Mark for Two Pediatric Heart Devices

    Includes pediatric mechanical heart valve and first minimally invasive device to treat premature babies and newborns born with an opening in their heart.

    Abbott Gains CE Mark for Two Pediatric Heart Devices
    Related CONTENT
    • Abbott's FreeStyle Libre 3 Receives CE Mark
    • Endologix Receives CE Mark for ALTO Abdominal Stent Graft System
    • Abbott’s MitraClip G4 Receives CE Mark
    • Abbott Introduces World's First Glucose Biosensor Designed for Athletes
    • CHF Solutions Develops Registry for Fluid Overload Conditions in Pediatric Patients
    Abbott Laboratories09.17.19
    Abbott announced approvals in Europe for two of its life-saving pediatric devices. The Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder have received CE mark and are now available in Europe and other countries that recognize CE mark. The new treatments, already available in the U.S., offer young pediatric patients and their families hope when no other suitable treatment option may exist. 
     
    Congenital heart defects (CHD) affect approximately 36,000 births in the European Union each year.1 The Masters valve is the world's smallest mechanical heart valve and allows doctors to treat babies and toddlers in need of a mitral or aortic heart valve replacement. The Amplatzer Piccolo is smaller than a pea and is the world's first medical device that can be implanted in the tiniest babies (weighing as little as under one kilogram) to treat patent ductus arteriosus, or PDA, a potentially life-threatening opening in the heart. These life-saving devices for certain congenital heart defects are the first and only devices of their kind.
     
    "Devices like these are among the best examples of our promise at Abbott to help people live their fullest lives—in this case, young babies and children for whom these treatments are nothing short of miraculous," said Michael Dale, vice president of Abbott's structural heart business. "While the children who benefit from these therapies represent a very small segment of the total population with structural heart disease, these advanced technologies enable physicians to treat vulnerable pediatric patients who otherwise have limited options.
     
    Smaller than a 1c euro, at just 15mm the Masters valve is the first and only pediatric mechanical heart valve developed for newborns and infants and is now available in the European Union. The valve is a rotatable, bileaflet mechanical heart valve designed for implantation in the mitral or aortic position and is part of the Masters Series line, which now includes seven valves with diameter sizes ranging from 15 to 27mm.
     
    When the tissues of the heart valve have a significant malformation or are too damaged and cannot be repaired to function properly, it may be necessary to replace the valve with a mechanical valve. A mechanical heart valve mimics a healthy heart valve, opening and closing with each heartbeat, permitting proper blood flow through the heart.
     
    Until Abbott's device, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, which could result in improper fit and complications. The Masters pediatric valve was approved in the United States in March 2018 and in Canada in October 2018.
     
    One of the most common congenital heart defects occurring in premature babies, PDA, is a potentially life-threatening opening between two blood vessels which lead from the heart. This channel, which is present in normally developing fetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus' body. For most infants, the pathway, or duct, seals itself shortly after birth. In some cases, primarily in babies born prematurely, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs. PDA accounts for up to 10% of all congenital heart disease.2
     
    The Amplatzer Piccolo, approved in the U.S. in January 2019, is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart. Many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the minimally invasive procedure. With the approval of the Amplatzer Piccolo in Europe and other countries that recognize CE mark, Abbott offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and high risk to undergo corrective surgery.
     
    The Amplatzer Piccolo device builds on more than 20 years of clinical success for Abbott's family of Amplatzer Occluder therapies, including the Amplatzer Duct Occluder family of products (ADO, ADOII and ADOIIAS), already approved for use in Europe and countries around the world to treat PDA in larger size pediatric patients.
     
    "Seeing the youngest patients fight for their lives is harrowing, and finally having solutions that can offer a dependable treatment option to get these little ones out of the NICU and sent home with their families is a huge advance in our field," said Dr. Mario Carminati, Director of Pediatric and Adult Congenital Cardiology at IRCCS Policlinico San Donato, Milan.
     
    References
    1 Dolk, Helen et al. "Congenital heart defects in Europe: prevalence and perinatal mortality, 2000 to 2005." Circulation 123 8 (2011): 841-9.
    2 Schneider, D. J., & Moore, J. W. (2006). Patent ductus arteriosus. Circulation, 114(17), 1873-18.
    Related Searches
    • body
    • heart
    • heart valve
    • technologies
    Suggested For You
    Abbott Abbott's FreeStyle Libre 3 Receives CE Mark
    Endologix Receives CE Mark for ALTO Abdominal Stent Graft System Endologix Receives CE Mark for ALTO Abdominal Stent Graft System
    Abbott’s MitraClip G4 Receives CE Mark Abbott’s MitraClip G4 Receives CE Mark
    Abbott Introduces World Abbott Introduces World's First Glucose Biosensor Designed for Athletes
    CHF Solutions Develops Registry for Fluid Overload Conditions in Pediatric Patients CHF Solutions Develops Registry for Fluid Overload Conditions in Pediatric Patients
    LivaNova Launches Perceval Plus Aortic Heart Valve in Europe LivaNova Launches Perceval Plus Aortic Heart Valve in Europe
    Medtronic to Begin Feasibility Study of Intrepid TTVR in Heart Valve Disease Medtronic to Begin Feasibility Study of Intrepid TTVR in Heart Valve Disease
    Smartphone-Controlled Wearable for Migraines Gains CE Mark Smartphone-Controlled Wearable for Migraines Gains CE Mark
    Abbott Begins Study for New Esprit BTK Fully Resorbable Stent Abbott Begins Study for New Esprit BTK Fully Resorbable Stent
    Guided Therapeutics LuViva Advanced Cervical Scan Wins New CE Mark With Expanded Claims Guided Therapeutics LuViva Advanced Cervical Scan Wins New CE Mark With Expanded Claims
    Feds to Buy $760M of Abbott Feds to Buy $760M of Abbott's $5, 15-Minute COVID-19 Test
    FDA Grants EUA to Abbott FDA Grants EUA to Abbott's $5, 15-Minute, COVID Antigen Test
    Heart Valve Innovator Foldax Closes $20 Million Financing Heart Valve Innovator Foldax Closes $20 Million Financing
    Expanded Pediatric Indication for Tandem Diabetes Expanded Pediatric Indication for Tandem Diabetes' t:slim X2 Insulin Pump
    Abbott Begins Study Evaluating New Device to Treat Recurrent AFib Abbott Begins Study Evaluating New Device to Treat Recurrent AFib

    Related Breaking News

    • Intersect ENT Announces CMS Approval of Coding Application for Sinus Implant

      Intersect ENT Announces CMS Approval of Coding Application for Sinus Implant

      Establishes new S code for Propel to facilitate specific coding and payment.
      Business Wire 01.19.21

    • 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

    • Global Tissue and Organ Transplantation Market to Surpass $25.6 Billion by 2027

      Global Tissue and Organ Transplantation Market to Surpass $25.6 Billion by 2027

      Growth will be driven mainly by R&D activities in tissue transplantation.
      Coherent Market Insights 01.19.21


    • Diagnostics
      Owlstone Medical Introduces Breath Biopsy Panel for Respiratory Diseases

      Owlstone Medical Introduces Breath Biopsy Panel for Respiratory Diseases

      Supports research to distinguish between different types of chronic inflammatory airway diseases.
      Owlstone Medical 01.19.21

    • Cognoptix Forms a New Board of Directors

      Cognoptix Forms a New Board of Directors

      The board is now comprised of a mix of healthcare investors and a leading expert on biomarker discovery.
      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

    • FDA Authorizes Interscope

      FDA Authorizes Interscope's EndoRotor System for Direct Endoscopic Necrosectomy

      Product allows physicians to simultaneously resect, aspirate necrotic material from a walled-off pancreatic collection under direct endoscopic visualization.
      PR Newswire 01.19.21

    • Surgical
      TransEnterix Wins EU Approval for Robotic Surgical Machine Vision System

      TransEnterix Wins EU Approval for Robotic Surgical Machine Vision System

      Intelligent Surgical Unit enables augmented intelligence on the Senhance surgical system.
      Business Wire 01.19.21


    • Telemedicine, Regulatory Changes to Characterize Medtech Industry in 2021

      Telemedicine, Regulatory Changes to Characterize Medtech Industry in 2021

      The global pandemic has created an urgent need for telemedicine.
      GlobalData 01.19.21

    • Digital Health | Software & IT
      Philips Buys Capsule Technologies in $635M Deal

      Philips Buys Capsule Technologies in $635M Deal

      Capsule offers vendor-neutral Medical Device Information Platform with an SaaS business model.
      GlobeNewswire 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


    • Apria Healthcare Settles Whistleblower Lawsuit

      Apria Healthcare Settles Whistleblower Lawsuit

      Company admits it continued seeking reimbursement from federal programs; agrees to pay $40.5 million to government.
      U.S. Attorney's Office, Southern District of New York 01.18.21

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

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

      Amendment will allow 3B BlackBio Biotech’s North American distributor to expand saliva COVID-19 PCR-based viral diagnostic testing across the U.S.
      OraSure Technologies Inc. 01.18.21

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

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

      Pandemic is forecast to drive much of the growth.
      GlobalData 01.18.21


    Trending
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Top 10 Trends In The Medical Device And Equipment Industry
    • An Analysis Of The Smart Inhalers Market
    Breaking News
    • Intersect ENT Announces CMS Approval of Coding Application for Sinus Implant
    • Hillrom to Buy Bardy Diagnostics for $375M
    • Global Tissue and Organ Transplantation Market to Surpass $25.6 Billion by 2027
    • Owlstone Medical Introduces Breath Biopsy Panel for Respiratory Diseases
    • Cognoptix Forms a New Board of Directors
    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

    BGG Obtains U.S. Patent on AstaZine Natural Astaxanthin for Heart Function During Exercise
    Qualitas Health/iwi Raises $10 Million in Investment Round
    Aker BioMarine Expands Krill Portfolio with Novel Protein Hydrolysate
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Launches Graphene Reinforced Dual System Ceramic Coating
    TAUBMANS Paint by PPG Releases ‘Chromatic Joy’ Palettes
    Huntsman Finalizes Acquisition of Gabriel Performance Products
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Intersect ENT Announces CMS Approval of Coding Application for Sinus Implant
    Hillrom to Buy Bardy Diagnostics for $375M
    Global Tissue and Organ Transplantation Market to Surpass $25.6 Billion by 2027
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bone Therapeutics, Rigenerand Ink Cell Therapy Deal
    NovaQuest Private Equity Acquires CoreRx
    JS Bio and Etta Biotech Advancing Partnership
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Clarins UK Partners with Vee24
    Alastin Skincare Named as Fastest Growing Skincare Brand
    JLo Beauty Launches at Sephora & Amazon
    Happi

    Latest Breaking News From Happi

    Top 10 Global Consumer Trends 2021
    A Surge in Interest for Supplements & Vitamins
    Gattefossé Launches Inspiration Collection
    Ink World

    Latest Breaking News From Ink World

    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Packaging Printing Market Worth $433.4 Billion by 2025: MarketsandMarkets
    O-I Foundation Gifts $50k to Facilitate COVID-19 Vaccine Access
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    ABG keeps pace with demand with recruitment drive
    Acucote expands FSC-certified portfolio
    German manufacturer develops label workflow tool
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Honeywell Delivered 225 Million Masks in December
    Techtextil, Texprocess Postponed to 2022
    Super Strong Inks Survive Tough Environments
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    DePuy Synthes Receives 510(k) FDA Clearance for VELYS Robotic-Assisted Solution
    OrthoPediatrics Expands Agent Network in Three European Countries
    Studies Show FlareHawk Expandable Cage Delivers Favorable Fusion, Patient Outcomes
    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