• 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
    PTI Engineered Plastics Inc.

    FUTEK Advanced Sensor Technology Inc.

    MW Life Sciences

    Unicep

    Medbio LLC
    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
    K-Tube Technologies

    Element

    Spectrum Plastics Group

    Qosina Corp.

    MW Life Sciences
    • 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 Begins TAVR Study Comparing Evolut Against Edwards' Sapien Valve

    Also begins feasibility study of Evolut in moderate and asymptomatic aortic stenosis patients.

    Medtronic Begins TAVR Study Comparing Evolut Against Edwards
    Related CONTENT
    • Alleviant's Transcatheter Tech Obtains Breakthrough Status
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    • MedAcuity, Fathom Partner on Human Factors Engineering Services
    • Cretex Companies CEO Steps Down
    PR Newswire10.14.20
    Medtronic plc announced it will begin a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). The SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic Evolut PRO and PRO+TAVR Systems against the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves manufactured by Edwards Lifesciences.
     
    Enrolling approximately 700 patients globally, the study will evaluate valve performance in patients with small annuli and those who are candidates for TAV-in-SAV procedures (transcatheter valve implanted inside of a failed surgical valve), which combined, represent more than 40 percent of the global TAVR market. Due to its focus on small annulus patients, the SMART Trial will enroll predominantly women, which will provide important clinical insight into a currently underrepresented patient population in TAVR literature. The study includes pre-specified endpoints of hemodynamic (blood flow) superiority and clinical non-inferiority with the Evolut platform for mortality, stroke, or rehospitalization at 12 months.
     
    "Hemodynamic performance is particularly important in many patients with aortic stenosis, including those with small annuli, surgical aortic valves needing a TAV-in-SAV procedure, patients with left ventricular dysfunction, and those who are young and most active. For many of these and other TAVR patients, valve design matters," said Howard C. Herrmann, M.D., the John Winthrop Bryfogle Professor of Cardiovascular Diseases and director of interventional cardiology in the Perelman School of Medicine at the University of Pennsylvania, and principal investigator and chair of the Steering Committee of the SMART Trial. "The outcome of this important head-to-head study will allow heart teams to more selectively tailor clinical decision making to ensure the right valve is selected for the right patient." Dr. Herrmann has received institutional research funding and financial compensation from Edwards Lifesciences and Medtronic.
     
    The first enrollment in the SMART Trial is targeted for early 2021.
     
    Medtronic Evaluates TAVR in New Patient Populations
    Medtronic also announced plans to begin a feasibility study of the Evolut TAVR platform to evaluate the self-expanding, supra-annular valve in patients with symptomatic moderate and asymptomatic severe aortic stenosis, new patient populations outside of current guidelines and indications for aortic valve replacement. The Evolut EXPAND TAVR I Feasibility Study, which has been submitted to the FDA for Investigational Device Exemption (IDE) approval, would enroll up to 150 patients across both subgroups and evaluate the use of TAVR in patients before signs of left ventricular dysfunction are observed, and will assess the clinical and hemodynamic performance of the Evolut TAVR system to inform future clinical work.
     
    "Moderate aortic stenosis, if left untreated, can be just as deadly for patients as the more severe forms of the disease," said Jeffrey Popma, M.D., chief medical officer and vice president, medical affairs for the Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic. "Limited clinical research has shown that early intervention may reduce the high rates of mortality often seen in these patients as the disease progresses further down the road. The outcomes observed from in this study will help shape our clinical strategy to pursue expansion of the therapy to new populations who may benefit."
     
    More than 2 million patients live with symptomatic moderate and asymptomatic aortic stenosis in the U.S., which represents more than 40 percent of the total AS population in the U.S. Moderate AS remains undertreated due to a lack of clinical evidence informing treatment guidelines, while asymptomatic AS is undertreated due to the absence of common symptoms that would indicate a heart valve problem, such as shortness of breath, fatigue, dizziness, chest pains or palpitations.
     
    The Evolut TAVR platform—including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems—is indicated for symptomatic severe AS patients across all risk categories (extreme, high, intermediate and low) in the U.S. In addition, bicuspid aortic valve patients across all risk categories may be candidates for TAVR in the U.S.
    Related Searches
    • Surgical
    • Cardiovascular
    Related Knowledge Center
    • Cardiovascular
    • Surgical
    Suggested For You
    Medtech Matters: Medtronic Medtech Matters: Medtronic's Robotic Surgery Status
    Medtech Makers: Material Science for Micromolding Medtech Makers: Material Science for Micromolding
    Alleviant Alleviant's Transcatheter Tech Obtains Breakthrough Status
    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    MedAcuity, Fathom Partner on Human Factors Engineering Services MedAcuity, Fathom Partner on Human Factors Engineering Services
    Cretex Companies CEO Steps Down Cretex Companies CEO Steps Down
    Are you prepared for EUDAMED actor registration module? Let’s get started Are you prepared for EUDAMED actor registration module? Let’s get started
    Data Show Porex Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    Endoscopic Hemostasis Devices Market Valued at $730 Million Endoscopic Hemostasis Devices Market Valued at $730 Million
    Henry Schein Buys Majority Interest in Prism Medical Products Henry Schein Buys Majority Interest in Prism Medical Products
    Boston Scientific Boston Scientific's Vercise Genus DBS Earns FDA Approval
    TPI Partners with Zeiss TPI Partners with Zeiss
    Neurent Medical Closes $25 Million Series B Financing Neurent Medical Closes $25 Million Series B Financing
    FDA OKs Canon Medical FDA OKs Canon Medical's AI-Powered, 90cm Bore CT

    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

    • 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


    Trending
    • Senseonics Forges Strategic Collaboration With Ascensia Diabetes Care
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Henry Schein Buys Majority Interest In Prism Medical Products
    • Top 10 Trends In The Medical Device And Equipment Industry
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    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

    Omega-3s Evidenced to Reduce Low-Grade Inflammation in Elderly Men
    MIND and Mediterranean Diets Linked to Later Onset of Parkinson’s Disease
    Kerry Launches Web-Based Tool for Plant-Based Formulation Challenges
    Coatings World

    Latest Breaking News From Coatings World

    Keyland Polymer UV Powder, LLC Launches UVMax Defender
    Scott McLaughlin to Race in PPG Colors During Rookie INDYCAR Season
    Vink Chemicals Offers parmetol PSG
    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

    Adare Pharma Solutions Opens New Small-Scale Lab
    Stevanato Group Launches After-sales Service Offering
    X-Chem Acquires IntelliSyn and AviSyn
    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

    Nice-Pak Receives EPA Approval for Disinfectant Wipes
    FDA Takes Major Action on Hand Sanitizers from Mexico
    Symrise Shares 2020 Sales Figures
    Ink World

    Latest Breaking News From Ink World

    Epson Partner Creates Label Applicators for Pharmaceutical Products
    Smurfit Kappa Sets New Sustainability Targets with Better Planet 2050
    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    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