• 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
    TPI Partners with Zeiss

    PPE Moves into New Manufacturing Facility

    Neurent Medical Closes $25 Million Series B Financing

    Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.

    FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
    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
    FUTEK Advanced Sensor Technology Inc.

    Spectrum Plastics Group

    Medbio LLC

    Qosina Corp.

    Concise Engineering
    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
    Qosina Corp.

    FUTEK Advanced Sensor Technology Inc.

    Element

    MW Life Sciences

    K-Tube Technologies
    • 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

    Real-World Study of Abbott's Portico TAVR Shows Excellent Clinical Outcomes at 30 Days

    Portico is the first fully resheathable, repositionable, retrievable device to replace aortic valve without major surgery.

    Real-World Study of Abbott
    Data presented at EuroPCR indicated excellent clinical outcomes for Portico in a real-world setting to treat common and life-threatening heart valve disease with minimally invasive option. Image courtesy of Abbott.
    Related CONTENT
    • Acutus Medical Launches AcQCross Transseptal System in Europe
    • New Company Formed to Develop Peripheral Venous Disease Treatments
    • LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M
    • Foldax Strengthens its Scientific and Medical Advisory Boards
    • Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve
    Abbott Laboratories05.22.18
    Abbott today announced treatment with the company's Portico transcatheter aortic valve replacement (TAVR) therapy was associated with excellent clinical outcomes at 30 days, including low rates of death, disabling stroke, and paravalvular leak. Additional benefits observed included reduction in New York Heart Association (NYHA) class severity, low rates of bleeding, and improvements in a six-minute walk test, allowing patients to return to their previous lifestyles and activity faster. Data from the PORTICO I study were presented during EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), and showed favorable short-term clinical outcomes for safety and performance—consistent with the Portico CE Mark study results that granted European regulatory approval.
     
    The Portico transcatheter aortic valve provides a minimally invasive treatment for patients diagnosed with severe aortic stenosis—a common and very serious valve disease—who are not candidates for open-heart surgery. More than one in eight people aged 75 and older have moderate or severe aortic stenosis,1 which is caused by a narrowing of the aortic valve opening in the heart that restricts blood flow from the left ventricle to the aorta.
     
    Most patients don’t have symptoms for decades, but once symptoms appear, the prognosis is poor without surgical treatment.2 The end result of severe aortic valve stenosis is the reduction in the heart's pumping ability, which can lead to shortness of breath, fatigue, and ultimately to heart failure3. Transcatheter aortic valve replacement provides a minimally invasive alternative to surgical aortic valve replacement, the treatment of choice for many patients affected by severe aortic stenosis.2
     
    "Patients with severe aortic stenosis require timely treatment to reduce symptoms and improve clinical outcomes and quality of life," said principal investigator Francesco Maisano, M.D., Prof., UniversitätsSpital Zürich, Switzerland. "These new data reinforce that treatment with the Portico valve is safe in a real-world setting—with robust clinical results—and confirm that Portico is an excellent solution for patients at increased risk for surgery."
     
    The PORTICO I study is a real-world, multicenter, prospective, single-arm study with independent adjudication of clinical events and independent echocardiography core-lab analysis.  The study will follow patients annually through five years in a real-world setting after being treated with Portico to assess long-term clinical outcomes. In the study, 941 patients were treated at 61 centers across the EU, Canada and Australia. At 30 days, the study showed patients who received Abbott's TAVR therapy had very low rates of all-cause mortality (2.7 percent; 25/941) and disabling stroke (1.7 percent; 16/941).
     
    At 30 days after implant, study patients had excellent hemodynamic performance (8.6 mm Hg), a measurement of forward blood flow resistance, and effective orifice area, or large valve opening, of (1.8 cm2), allowing blood to easily flow from the left ventricle of the heart to the aorta. Nearly all patients (96.1 percent) experienced none-to-mild paravalvular leak which may result after a mitral or aortic valve replacement procedure. The percentage of patients in NYHA class III/IV significantly decreased from 64 percent to 13.1 percent, indicating improved mobility, and clinical measures showed a mean improvement of 26 meters in the six-minute walk test. No severe aortic valve regurgitation, or leak, based on Independent Core Lab-assessed echocardiographic analysis, was seen at 30 days.
     
    "When developing the Portico valve, our goal was to provide physicians with new offerings that would improve deliverability, placement accuracy and performance when replacing a diseased or damaged aortic heart valve using a minimally invasive therapy," said Michael Dale, vice president of Abbott's structural heart business. "The findings of the PORTICO I real-world study corroborate those from our previous clinical trials, which showed that Portico is a life-saving valve that improves quality of life and helps patients resume their day-to-day activities."
     
    Portico recently received regulatory approval in Europe for a sheathless introduction of the Portico valve, allowing physicians to deliver it without an arterial introducer sheath. Use of the Portico Transcatheter Aortic Valve system without an arterial delivery sheath reduces the valve profile further, making it easier for physicians to insert the device in patients with severe disease and complex anatomies. The smaller size of the valve may lower the risk of serious adverse events and vascular complications such as internal damage to the arteries.4,5,6,7

    The Portico Transcatheter Aortic Valve is approved for investigational use only in the U.S.
     
    References
    1 Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet 2006;368:1005-11
    2 Nardi P, Russo M, Saitto G, et al. The Treatment of Aortic Valve Stenosis in Patients at Intermediate-High Risk. Interv Cardiol J. 2016, 2:2.
    3 Osnabrugge RLJ, Mylotte D, Head SJ, et al; Aortic Stenosis in the Elderly: Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study. Journal of the American College of Cardiology. 2013; 11:1002-1012.
    4 Taramasso et al. “Feasibility and safety of Transfemoral Sheathless Portico Aortic Valve Implantation.” Catheter Cardiovasc Interv. 2017 May 13. doi: 10.1002/ccd.271005.  
    5 Bruschi et al. “Portico Sheathless Transcatheter Aortic Valve Implantation via Distal Axillary Artery.” Ann Thorac Surg. 2017 Feb;103(2):e175-e177. doi: 10.1016/j.athoracsur.2016.07.065
    6 Denegri et al. “Real-world procedural and 30-day outcome using the Portico transcatheter aortic valve prosthesis:” Int J Cardiol. 2018 Feb 15;253:40-44. doi: 10.1016/j.ijcard.2017.10.101. Epub 2017 Nov 10
    7 Taramasso M. Feasibility and Safety of Transfemoral Sheathless Portico Aortic Valve Implantation: Prelimary Results in a Single Center Experience Catheterization and Cardiovascular Interventions 91:533–539 (2018).
    8 Möllmann H et al. Portico TF EU Pre-CE Mark 30d outcomes for all 4 valve sizes. J Am Coll Cardiol Intv. 2017; 10:1538–47.
    Related Searches
    • president
    • ce mark
    • vice president
    • australia
    Related Knowledge Center
    • Cardiovascular
    • Surgical
    Suggested For You
    Acutus Medical Launches AcQCross Transseptal System in Europe Acutus Medical Launches AcQCross Transseptal System in Europe
    New Company Formed to Develop Peripheral Venous Disease Treatments New Company Formed to Develop Peripheral Venous Disease Treatments
    LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M
    Foldax Strengthens its Scientific and Medical Advisory Boards Foldax Strengthens its Scientific and Medical Advisory Boards
    Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve
    Former Medtronic, St. Jude Executive Assumes CCO Role at JenaValve Former Medtronic, St. Jude Executive Assumes CCO Role at JenaValve
    Global Coronary Stents Market to Exceed $15.1 Billion by 2027 Global Coronary Stents Market to Exceed $15.1 Billion by 2027
    ACURATE Neo TAVR Valve Fails to Demonstrate Non-Inferiority ACURATE Neo TAVR Valve Fails to Demonstrate Non-Inferiority
    Medtronic Begins TAVR Study Comparing Evolut Against Edwards Medtronic Begins TAVR Study Comparing Evolut Against Edwards' Sapien Valve
    Abbott Abbott's FreeStyle Libre 3 Receives CE Mark
    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
    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
    Abbott Begins Study for New Esprit BTK Fully Resorbable Stent Abbott Begins Study for New Esprit BTK Fully Resorbable Stent

    Related Breaking News

    • 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

    • Surgical
      Freehand Partners with Imperial Medical Solutions

      Freehand Partners with Imperial Medical Solutions

      Supports the introduction of its surgical robots in India, Sri Lanka, Malaysia and the Caribbean.
      Freehand 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


    • 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

    • 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


    • 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


    Trending
    • Telemedicine, Regulatory Changes To Characterize Medtech Industry In 2021
    • Philips Buys Capsule Technologies In $635M Deal
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • TPI Partners with Zeiss
    • PPE Moves into New Manufacturing Facility
    • Neurent Medical Closes $25 Million Series B Financing
    • Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.
    • FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
    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

    NIH Study Compares Low-Fat, Plant-based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Launches Graphene Reinforced Dual System Ceramic Coating
    Miller Paint Declares Simple Serenity its 2021 Color of the Year
    TAUBMANS Paint by PPG Releases ‘Chromatic Joy’ Palettes
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    TPI Partners with Zeiss
    PPE Moves into New Manufacturing Facility
    Neurent Medical Closes $25 Million Series B Financing
    Contract Pharma

    Latest Breaking News From Contract Pharma

    WDSrx Expands Warehouse Network
    Piramal Inks Clinical Supply Deal with Theratechnologies
    Recipharm Signs Manufacturing Deal with Enzymatica
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Lageen Tubes Launches Mono-Material PE Tube Solutions
    Jason Jones Loses Battle with Covid-19
    Weleda Celebrates 100 Years By 'Opening' Its Gardens
    Happi

    Latest Breaking News From Happi

    NY's 1,4-Dioxane Law May Impact Concentrated Cleaners
    Sabinsa's Top Scientist Addresses US FDA
    Ipsy Adds New Personal Care Brand
    Ink World

    Latest Breaking News From Ink World

    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    THIMM Group Installs 1st Koenig & Bauer CorruFLEX
    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Lemu Group engineers mask-making machine
    Niagara Label upgrades with Nilpeter flexo press
    Soma partners with Moore & Moore in US
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Lemu Group Engineers Mask-Making Machine
    Armbrust American Adds Meltblown Manufacturing
    P&G Reports 8% Sales Increase
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Siemens Healthineers’ DR Systems Cleared by FDA
    Former Medtronic Exec Appointed Zimmer Biomet's Chief Transformation Officer
    SeaSpine Launches Regatta Lateral Plates
    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