• 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
    FUTEK Advanced Sensor Technology Inc.

    S-Y-M Products Company

    Carclo Technical Plastics

    Lyons

    Glenbrook Technologies Inc.
    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
    Halkey-Roberts Corporation

    Carclo Technical Plastics

    K-Tube Technologies

    Marox Corporation

    Pulse Systems
    • 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 OKs J&J's EMBOTRAP II Stent Retriever Device for Ischemic Stroke

    CERENOVUS' device captures and pemoves life-threatening blood clots, rapidly restores blood flow.

    FDA OKs J&J
    Image courtesy of PRNewsfoto/CERENOVUS.
    Related CONTENT
    • Tryton Medical Announces New President & CEO
    • First Patient Enrolled in U.S. IDE Study to Evaluate New Device to Reduce Stroke Risk
    • Microbot Appoints Codman Neurosurgery President to its Board of Directors
    • Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
    • AtriCure Names Board Chairman
    PR Newswire05.21.18
    CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EMBOTRAP II Revascularization Device, a next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke.
     
    Stroke strikes nearly 800,000 Americans each year, and is a leading cause of disability and the fifth leading cause of death.1 For stroke patients, the difference between life and death, and functional independence or disability, is tied to timely restoration of blood flow to the oxygen-starved brain after a stroke occurs.
     
    The EMBOTRAP II Device is designed to rapidly restore blood flow by gripping and retrieving clots within the neurovasculature, with minimal compression, protecting against further complications. The specific design of this mechanical thrombectomy device, which is indicated for use within eight hours of stroke symptom onset, is the result of extensive research into the science of clot.  
     
    In the ARISE II study, which was submitted as part of the 510(k) application to FDA, neurointerventional stroke physicians were able to restore blood flow in 80 percent of patients treated within three passes and in about half of patients within a single pass. At the 90-day follow-up, more than two-thirds were functionally independent. The study included 228 patients with large vessel occlusions and moderate to severe neurological deficits.
     
    "Mechanical thrombectomy with newer generation devices is increasingly becoming standard treatment for acute ischemic stroke," said Osama Zaidat, MD, Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital, and lead author of the ARISE II study, which was published in the peer-reviewed journal, Stroke, earlier this year. "The EMBOTRAP II Device with its high first pass rate and its ability to address such a broad range of clot is a crucial step forward for stroke treatment in America." 
     
    The device is also approved for use in Europe, where more than 3,000 patients have been treated.
     
    "EMBOTRAP II is the product of deep collaboration between engineers and clinicians to better understand the science of blood clot, what causes them to form and how a mechanical thrombectomy device can interact with them to help improve outcomes," said Daniella Cramp, Worldwide President, CERENOVUS. "CERENOVUS is committed to advancing treatment with evidence-based solutions so that fewer and fewer people are affected by the ravages of stroke."
     
    The EMBOTRAP II Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within eight hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
     
    Reference
    1 Impact of Stroke (Stroke statistics). Stroke Treatment. http://www.strokeassociation.org/STROKEORG/AboutStroke/Impact-of-Stroke-Stroke-statistics_UCM_310728_Article.jsp#.Wvycyu4vzIV. Published June 6, 2016.
    Related Searches
    • it
    • stent
    • research
    • u.s. food and drug administration
    Related Knowledge Center
    • Neurological
    • Cardiovascular
    Suggested For You
    Medtech M&A Off to a Strong Start in 2018 Medtech M&A Off to a Strong Start in 2018
    Study Links Powered Stapler Use With Reduced Rates of Bleeding Complications in Thoracic Surgery Study Links Powered Stapler Use With Reduced Rates of Bleeding Complications in Thoracic Surgery
    Lawsuit Alleges J&J Breast Implants Caused Lymphoma in Ohio Woman Lawsuit Alleges J&J Breast Implants Caused Lymphoma in Ohio Woman
    Acclarent Lanches 3D Navigation System Designed to Transform ENT Procedures Acclarent Lanches 3D Navigation System Designed to Transform ENT Procedures
    FDA Clears First Contact Lens with Light-Adaptive Technology FDA Clears First Contact Lens with Light-Adaptive Technology
    Johnson & Johnson Johnson & Johnson's Longtime CFO to Retire
    J&J Receives $2.1B Offer for LifeScan Glucometer Business J&J Receives $2.1B Offer for LifeScan Glucometer Business
    First Patient Treated in Study of Biosense Webster First Patient Treated in Study of Biosense Webster's Multi-Electrode RF Balloon Catheter
    Manufacturing’s Great Opportunity Manufacturing’s Great Opportunity
    AtriCure Names Board Chairman AtriCure Names Board Chairman
    Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
    Microbot Appoints Codman Neurosurgery President to its Board of Directors Microbot Appoints Codman Neurosurgery President to its Board of Directors
    First Patient Enrolled in U.S. IDE Study to Evaluate New Device to Reduce Stroke Risk First Patient Enrolled in U.S. IDE Study to Evaluate New Device to Reduce Stroke Risk
    Tryton Medical Announces New President & CEO Tryton Medical Announces New President & CEO

    Related Breaking News

    • Diagnostics | Neurological
      Eye Test for Parkinson

      Eye Test for Parkinson's Gains Breakthrough Designation

      The RightEye Vision System identifies ocular tremors that may help to detect the disease at an earlier stage.
      PR Newswire 12.05.19

    • Diagnostics | Neurological
      RSNA News: MaxQ AI Expands Partnership with GE

      RSNA News: MaxQ AI Expands Partnership with GE

      MaxQ AI’s ACCIPIO ICH and Stroke platform will be integrated into GE Healthcare’s PACS solution.
      MaxQ Al 12.04.19

    • Diagnostics | Neurological
      RSNA News: MaxQ AI to Offer Accipio Applications on Blackford Platform

      RSNA News: MaxQ AI to Offer Accipio Applications on Blackford Platform

      Represents cost savings and increased quality of care.
      MaxQ AI 12.04.19


    • Diagnostics | Neurological
       RSNA News: MaxQ AI’s Software Integrated with Philips

      RSNA News: MaxQ AI’s Software Integrated with Philips' Tech

      The company’s Accipio Intracranial Hemorrhage and stroke software will be added to Philips’ CT systems
      MaxQ 12.04.19

    • Neurological
      The First Implantable Magnetic Resonance Detector

      The First Implantable Magnetic Resonance Detector

      Ultra-fine needle with an integrated chip that is capable of detecting and transmitting nuclear magnetic resonance (NMR) data.
      Max Planck-Gesellschaft 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

    • 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


    • 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

    • 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

    • Neurological
      Theranica Announces U.S. Recycling Partnership

      Theranica Announces U.S. Recycling Partnership

      Partnership advances circular economy by making Nerivio, a prescribed wearable for acute treatment of migraine, recyclable.
      Theranica Bioelectronics 11.19.19

    • Neurological
      Ekso Bionics Unveils EksoNR

      Ekso Bionics Unveils EksoNR

      The next-generation exoskeleton for neurorehabilitation.
      Ekso Bionics 11.18.19

    • Cardiovascular | Materials | Tubing & Extrusion
      CVC Manufactured from Special Urethane Material that Becomes Softer in the Body

      CVC Manufactured from Special Urethane Material that Becomes Softer in the Body

      Optimized design of central venous catheters reduces risk of complications.
      Flexan 11.18.19

    • Cardiovascular | Digital Health | Patient Monitoring | Software & IT
      Preventive Healthcare via Apps

      Preventive Healthcare via Apps

      Prevention through digital helpers from Fraunhofer and partners.
      Fraunhofer-Gesellschaft 11.18.19


    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.