• 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
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    FDA OKs Roche's Nasal Swab MRSA Test

    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs

    Eye Test for Parkinson's Gains Breakthrough Designation

    Biomerics Forms New Business Unit

    J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    From Genome Sequencing to the World’s First Portable MRI

    An Update on Digital Health

    ‘If You’re Reading This, You Need to Be at This Meeting’

    Five Steps for Succeeding Globally in Medtech

    Unlocking Market Doors with Real-World Evidence
    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
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Halkey-Roberts Corporation

    Pulse Systems

    Aran Biomedical

    GS Plastic Optics

    Accumold
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Understanding Key Processes for Mixing APIs with Silicone

    How to Minimize Color Variations in Your Medical Device

    Don’t Touch: Gesture Tech Is Reshaping How We Interact with Devices

    Revenue-Based Financing: A New Form of Growth Capital

    Pre-Filled Safety Syringes and the Self-Administration Trend
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Zeus

    Marox Corporation

    Pulse Systems

    GS Plastic Optics

    Aran Biomedical
    • 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
    • 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

    FDA Approves Medtronic's Transcatheter Valve with Advanced Sealing

    Self-expanding, recapturable heart valve demonstrates high survival, low stroke, and minimal paravalvular leak.

    FDA Approves Medtronic
    Related CONTENT
    • FDA Warns of Potential Fires and Explosions From Battery-Powered Medical Carts
    • FDA Clears Voxello's Speech Generation Device
    • Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use
    • FlowAid Receives FDA Clearance for the FA100 SCCD
    • FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device
    Medtronic03.22.17
    Medtronic plc announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval comes on the heels of new 30-day clinical data that was unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Session, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve.
     
    The Evolut PRO device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.
     
    "Based on my experience implanting the Evolut PRO valve during the clinical study, I've been impressed by the clinical outcomes achieved in our patients," said Mathew Williams, M.D., chief of Adult Cardiac Surgery and director of Interventional Cardiology and the Heart Valve Program at the NYU Langone Medical Center in New York City. "This represents an important advantage over previous generations of this device, as it can help assist with adequate sealing even in complex cases."
     
    The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3 percent) and low rates of disabling stroke (1.7 percent). The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The majority of study subjects (72.4 percent) experienced no/trace PVL and no incidents of moderate or severe PVL were observed at 30 days. Additionally, improving on the already low rates seen in Evolut R clinical studies and real-world TVT and FORWARD registries, the rate of new pacemaker implantation was 10 percent.
     
    "The 30-day clinical outcomes presented at ACC demonstrate the Evolut PRO valve to be an outstanding treatment option for patients with severe aortic stenosis who are at a high or extreme risk for surgery," said John Forrest, M.D., assistant professor of medicine at Yale University School of Medicine in New Haven, Conn., who presented the data at the meeting.
     
    Built on the proven platform of the recapturable CoreValve Evolut R System, the Evolut PRO valve includes a self-expanding nitinol frame with its supra-annular valve position that helps achieve excellent hemodynamic performance.
     
    "Medtronic remains committed to working with interventional cardiologists and cardiac surgeons to deliver solutions that address patient needs with the safety and performance profile they expect from Medtronic," said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, a part of Medtronic's Cardiac and Vascular Group. "We are excited to introduce the next evolution of our Evolut TAVR platform to provide physicians with a comprehensive portfolio to address their patients' needs."
     
    The Evolut PRO System is delivered through the EnVeo R Delivery Catheter System and is indicated for vessels down to 5.5 mm. The EnVeo R system features an InLine Sheath that makes it the lowest delivery platform currently on the market. It also provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route.
     
    The 23, 26, and 29 mm sizes of the Evolut PRO System are available for use in the United States. It is not available for use in countries outside of the United States.
    Related Searches
    • it
    • tavr
    • stroke
    • corevalve evolut r system
    Related Knowledge Center
    • Cardiovascular
    • Surgical
    Suggested For You
    Shockwave Medical Appoints President and CEO Shockwave Medical Appoints President and CEO
    FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers
    Medtronic Launches Resolute Onyx Drug-Eluting Stent in U.S. Medtronic Launches Resolute Onyx Drug-Eluting Stent in U.S.
    FDA Designates N8 Medical FDA Designates N8 Medical's CeraShield Endotracheal Tube as a Breakthrough Device
    Medtronic Launches Advanced StealthStation for Neurosurgery Medtronic Launches Advanced StealthStation for Neurosurgery
    FDA Designates Medtronic Action as Class I Recall FDA Designates Medtronic Action as Class I Recall
    Medtronic Divests Technology to Cardinal Health for $6.1 Billion Medtronic Divests Technology to Cardinal Health for $6.1 Billion
    Medtronic Syncs Garmin Tracker Data into Patient Monitoring Platform Medtronic Syncs Garmin Tracker Data into Patient Monitoring Platform
    FDA Clears First Whole Slide Imaging System for Digital Pathology FDA Clears First Whole Slide Imaging System for Digital Pathology
    Personalized 3D Brain Maps to Guide Neurosurgeries Personalized 3D Brain Maps to Guide Neurosurgeries
    Medtronic Recalls StrataMR Adjustable Valves and Shunts Medtronic Recalls StrataMR Adjustable Valves and Shunts
    Collaborating on Custom Materials Development Collaborating on Custom Materials Development
    Extractable/Leachable Chemistry Testing Strategies for Medical Devices Extractable/Leachable Chemistry Testing Strategies for Medical Devices
    Closing the Loop on Diabetes Care Closing the Loop on Diabetes Care
    Medtronic Medtronic's Melody TPV Approved for Implantation in Failed Surgical Pulmonary Heart Valves

    Related Breaking News

    • Surgical
      J&J

      J&J's New Monofocal IOL for Cataract Patients with Astigmatism

      TECNIS Toric II 1-Piece IOL features more surface texture and friction on IOL haptics.
      PR Newswire 12.05.19

    • Surgical
      First Surgical Robot to Achieve Breakthrough Status Granted to Vicarious Surgical

      First Surgical Robot to Achieve Breakthrough Status Granted to Vicarious Surgical

      The company also appointed former Verb Surgical leader Scott Huennekens to its Board of Directors.
      PR Newswire 12.05.19

    • Surgical
      Grifols Introduces its First Plasma Protein-Based Biosurgery Product

      Grifols Introduces its First Plasma Protein-Based Biosurgery Product

      VISTASEAL, a fibrin sealant developed for biosurgical bleeding-control, contains a combination of two plasma proteins.
      Grifols 12.04.19


    • Surgical
      Levita Magnetics Reaches 1,000th Magnetic Surgery Milestone

      Levita Magnetics Reaches 1,000th Magnetic Surgery Milestone

      Technology offers patients a less invasive alternative in surgical procedures.
      Business Wire 12.04.19

    • 3D/Additive Manufacturing | Patient Monitoring | Surgical
      RSNA News: GE Invests in 3D Printing, Robotic Surgery, and Virtual Patient Monitoring

      RSNA News: GE Invests in 3D Printing, Robotic Surgery, and Virtual Patient Monitoring

      Investments and collaborations in these fields were made with Formlabs, CMR Surgical, and Decisio Health.
      GE Healthcare 12.03.19

    • Cardiovascular | Patient Monitoring
      VivaLNK Wearable Sensor and Software Development Kit Receive CE Mark

      VivaLNK Wearable Sensor and Software Development Kit Receive CE Mark

      The reusable patch weighs only 7.5 grams.
      PRNewswire 12.03.19


    • Cardiovascular | Surgical
      CryoLife

      CryoLife's Thoraco-abdominal Stent Graft Gains CE Mark

      First off-the-shelf option with pre-cannulated inner branch technology.
      PR Newswire 12.03.19

    • Surgical
      Ethicon Launches Device to Help Surgeons Better Manage Bleeding

      Ethicon Launches Device to Help Surgeons Better Manage Bleeding

      Next-generation product simplifies setup and may save valuable operating room time.
      Johnson & Johnson Medical Devices Companies 12.03.19

    • Surgical
      Baxter Acquires Seprafilm Adhesion Barrier

      Baxter Acquires Seprafilm Adhesion Barrier

      Expands advanced surgery portfolio.
      PRNewswire 12.02.19


    • Cardiovascular
      Concept Medical Granted CE Certification for its Sirolimus Coated MagicTouch Group of Products

      Concept Medical Granted CE Certification for its Sirolimus Coated MagicTouch Group of Products

      Company is now focused on marketing the products in Europe.
      Businesswire 11.25.19

    • Cardiovascular
      Bristol-Myers Squibb-Pfizer Alliance, Fitbit Partner to Address Gaps in Afib Detection

      Bristol-Myers Squibb-Pfizer Alliance, Fitbit Partner to Address Gaps in Afib Detection

      Companies are joining forces to develop atrial fibrillation educational content to help identify and support those at increased risk of stroke.
      Businesswire 11.25.19

    • Surgical
      Caliber Ophthalmics Introduces Sharpoint Edge CC3D Plus Product Line

      Caliber Ophthalmics Introduces Sharpoint Edge CC3D Plus Product Line

      Sharpoint Edge CC3D Plus Phaco Incision Knives have vertical micro bevels in its blade geometry that produce a 3-D incision designed to enhance surgeon control.
      PR Newswire 11.20.19

    • Cardiovascular | Digital Health
      Biofourmis Partners with Novartis

      Biofourmis Partners with Novartis

      Teams up to offer digital therapeutics for patients with heart failure.
      Biofourmis 11.19.19

    • Surgical
      Xact Robotics Completes Latest Financing Round

      Xact Robotics Completes Latest Financing Round

      Proceeds total $36M.
      Xact Robotics 11.19.19

    • Cardiovascular
      First Patient in Middle East Treated With CSI

      First Patient in Middle East Treated With CSI's Peripheral Orbital Atherectomy Technology

      Introduction of Orbital Atherectomy expands treatment options for patients with peripheral artery disease.
      Business Wire 11.19.19


    Breaking News
    • FDA OKs Roche's Nasal Swab MRSA Test
    • Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    • Eye Test for Parkinson's Gains Breakthrough Designation
    • Biomerics Forms New Business Unit
    • J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • Adding Fabrication Capabilities: Additive Manufacturing for Production Parts
    • Delivering the Goods: The Evolving World of Combination Products
    • Anxious Undertones: The 2019 Year in Review
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    International Scientific Society Calls for Omega-3 Blood Testing in Future Research
    Pharmactive Affron Saffron May Help Relieve Depression Symptoms
    Warmer Temperatures Could Lead to Concerning Levels of Arsenic in Rice
    Coatings World

    Latest Breaking News From Coatings World

    Cristo Rey High School Educator Named 2019 Axalta All-Pro Teacher of the Year
    Michelman Makes United Way of Greater Cincinnati’s List of Top 25 Corporate Campaigns
    BCF: Coatings Industry Reports Record Improvement in Waste, Recycling, Accident Rates
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs Roche's Nasal Swab MRSA Test
    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    Eye Test for Parkinson's Gains Breakthrough Designation
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Almac Awarded $1M BMGF Grant
    Vivera Pharma, Parexel Ink Clinical Services Agreement
    MedPharm Triples Capacity at RTP Site
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    WWP Wins Three NJPEC Awards
    Cat-Themed Beauty Collection to Launch in Japan
    Pantone Names Classic Blue the 2020 Color of the Year
    Happi

    Latest Breaking News From Happi

    Lip Lab Opening in Brooklyn
    Raining Rose Expands Exec Team
    Scott’s Sells Personal Care Production Site
    Ink World

    Latest Breaking News From Ink World

    ePac Flexible Packaging Expands into Asia Pacific Market
    Haney, HP Developing Sustainable Fashion Packaging for Heron Preston
    Addipel Moves to New HQ, Expands Production Facility
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    HP teams with Haney for sustainable packaging
    Tags & Labels Printing adds Heidelberg’s Versafire EP
    Austrian converter installs first Nilpeter press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Thrace to Relocate U.S. Capacity
    FiltXPO Speaker Line-Up Announced
    Nölken Incorporates Sustainable Wipes Packaging
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Appoints New Spine Business Leader
    Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    Synaptive Medical's Modus V Expands Into Spine Market
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    IDTechEx Show! Announces Graphene Award Winner
    OE-A Continues to Bring Future of Printed Electronics to CES 2020
    Avancis, Smit Thermal, HZB, CNRS, Solliace Team for Higher Efficiencies in CIGS

    Copyright © 2019 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.