• 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
    20 Years: A Discussion on the Past & Future of Medical Product Outsourcing

    A Combined Effort for Drug Delivery & Combo Product Technology

    Examining Medical Packaging & Sterilization on Multiple Fronts

    Medical Molding Modernized

    Computer Concepts for Medical Device Design
    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
    Regulatory
    Financial/Business
    Top News
    Teleflex’s Wattson temporary pacing guidewire FDA cleared

    PDC Partners with David Schnur Associates to Provide Manufacturing Solutions

    Olympus Releases Next-Gen ESG-410 Electrosurgical Generator

    NICO Corporation Touts Positive ENRICH Trial Results

    Study Reveals Graphene-Based Biosensors' Potential in Detecting Critical Biomarker
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    20 Years: A Discussion on the Past & Future of Medical Product Outsourcing

    A Combined Effort for Drug Delivery & Combo Product Technology

    Examining Medical Packaging & Sterilization on Multiple Fronts

    Medical Molding Modernized

    Computer Concepts for Medical Device Design
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Elizabeth Holmes’ Pre-Prison Public Persona

    Trending in Healthcare Dealmaking: Creativity, Diversification, and Distress

    How Human Factors Engineering Can Contribute to Medical Device Packaging

    How Companies Can Create a Unique Selling Proposition

    Updating Medical Device Software in the Field
    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
    Cirtec Medical

    Medbio LLC

    LEMO USA Inc.

    Providence Enterprise USA Inc.

    JBC Technologies
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How the CHIPS Act and R&D Tax Credits Will Shape the Medtech Manufacturing Landscape

    Solving the Skills Gap Stalling the March of UK Life Sciences

    5 Ways to Reduce Nearshoring & Reshoring Costs Using Automation

    The Future of Hearing Aids: xMEMS Develops All-Silicon, Solid-State Micro Speaker

    Navigating Chinese Regulatory Requirements for Medical Device Localization
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    Medbio LLC

    LEMO USA Inc.

    Providence Enterprise USA Inc.

    JBC 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
    • eBook
    • Resources
    • Podcasts
    • 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

    Surmodics Receives CE Mark for Drug Coated Balloon

    Next gen device adds new technology to how physicians approach treatment of PAD.

    Surmodics Receives CE Mark for Drug Coated Balloon
    PAD is a serious and often underdiagnosed circulatory condition caused by a build-up of arterial plaque, most commonly in the legs. Image courtesy of Surmodics.
    Business Wire06.08.20
    Surmodics Inc., a provider of medical device and in vitro diagnostic technologies to the health care industry, has received CE Mark Certification in the European Union for its SurVeil drug-coated balloon (DCB).
     
    “I am excited about the potential of the SurVeil DCB to improve the treatment of PAD,” said professor Marianne Brodmann MD, PhD, interventional cardiologist at Medical University Graz (Austria) and a principal investigator in Transcend, Surmodics’ pivotal clinical trial for the SurVeil DCB. “Drug-coated balloons have been widely utilized in Europe as a frontline treatment for PAD."
     
    The SurVeil DCB, a next-generation device that utilizes best-in-class technology in the treatment of peripheral artery disease (PAD), includes a proprietary drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. Pre-clinical data have shown a more evenly distributed and durable drug effect, and lower incidence of downstream drug particles compared to the control drug-coated balloon.1
     
    “This CE Mark is a critical milestone and an exciting step forward for Surmodics as we continue to demonstrate industry leadership in the development of pioneering vascular medical devices,” said Gary Maharaj, president and chief executive officer of Surmodics. “The design of the SurVeil DCB reflects our dedication to providing innovative solutions that bring real clinical value – benefitting both clinicians and the patients that they treat.”
     
    In February 2018, Surmodics entered into an agreement with Abbott that provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB. Pursuant to the terms of the agreement, Surmodics received a $25 million upfront payment and a $10 million milestone payment for the completion of patient enrollment in the Transcend clinical trial. As a result of CE Mark attainment, Surmodics will receive an additional $10.8 million milestone payment. The company will recognize approximately $6.5 million as revenue in its fiscal third quarter and could earn up to an additional $45 million for future product development milestones. Surmodics is not forecasting material revenue from the sale of its SurVeil DCB product over the remainder of its fiscal year ending September 30, 2020.
     
    Under the agreement, Surmodics will be responsible for the manufacture and supply of clinical and commercial quantities of the product and will realize revenue based on initial product sales to Abbott as well as a share of profits resulting from third-party sales. The SurVeil DCB is not available for sale and is for investigational use only in the United States.
     
    Reference
    1. Surmodics data on file.
    Related Searches
    • Cardiovascular
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Innovation and Expertise Drive Evolution in Medical Device Manufacturing Innovation and Expertise Drive Evolution in Medical Device Manufacturing
    Let There Be Light: UV Disinfection Technology Let There Be Light: UV Disinfection Technology
    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
    Inventor of GORE-TEX Technology Dies at 83 Inventor of GORE-TEX Technology Dies at 83
    NextPhase Medical Device Announces New CCO NextPhase Medical Device Announces New CCO
    STEWART Industries Launches Medical Device Division STEWART Industries Launches Medical Device Division
    Smartphone-Controlled Wearable for Migraines Gains CE Mark Smartphone-Controlled Wearable for Migraines Gains CE Mark
    Korean Ophthalmic Medical Device Developer Launches U.S. Subsidiary Korean Ophthalmic Medical Device Developer Launches U.S. Subsidiary
    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
    Medtronic Cryoablation Outperforms Drug Therapy for Symptomatic Paroxysmal AFib Medtronic Cryoablation Outperforms Drug Therapy for Symptomatic Paroxysmal AFib
    Disruptive Medical Device Cybersecurity Solution Disruptive Medical Device Cybersecurity Solution
    Data Reconfirms Long-Term Safety of Philips Stellarex Low-Dose Drug-Coated Balloon Data Reconfirms Long-Term Safety of Philips Stellarex Low-Dose Drug-Coated Balloon
    Avive Solutions Raises Additional $7 Million for Cardiac Arrest Response Technology Avive Solutions Raises Additional $7 Million for Cardiac Arrest Response Technology

    Related Online Exclusives

    • Contract Manufacturing
      Innovation and Expertise Drive Evolution in Medical Device Manufacturing

      Innovation and Expertise Drive Evolution in Medical Device Manufacturing

      MICRO’s president offers a look at the company his family founded 75 years ago as well as the industry it’s supported.
      Brian Semcer, President, MICRO 09.29.20

    • Let There Be Light: UV Disinfection Technology

      Let There Be Light: UV Disinfection Technology

      In this interview with UV-Concepts’ President, Jeremy Starkweather, he offers insights on the use of the technology in healthcare environments.
      Sean Fenske, Editor-in-Chief 09.28.20

    • Chronic Disease
      Abbott

      Abbott's FreeStyle Libre 3 Receives CE Mark

      Features world's smallest, thinnest sensor with best-in-class performance at the same low cost for people with diabetes.
      PR Newswire 09.28.20


    • Endologix Receives CE Mark for ALTO Abdominal Stent Graft System

      Endologix Receives CE Mark for ALTO Abdominal Stent Graft System

      Product provides patients and physicians with an endograft capable of treating the highest proportion of patients within its indications for use.
      Business Wire 09.25.20

    • Cardiovascular
      Abbott’s MitraClip G4 Receives CE Mark

      Abbott’s MitraClip G4 Receives CE Mark

      Offers physicians an innovative system with more options for mitral valve repair using proven clip-based technology.
      Abbott 09.21.20

    Loading, Please Wait..

    Trending
    • Olympus To Establish Digital Excellence Centers
    • A New Approach To Post-Market Surveillance
    • Philips Names New Supervisory Board Chairman
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Labcorp's Clinical Development Spinoff To Be Called Fortrea
    Breaking News
    • Teleflex’s Wattson temporary pacing guidewire FDA cleared
    • PDC Partners with David Schnur Associates to Provide Manufacturing Solutions
    • Olympus Releases Next-Gen ESG-410 Electrosurgical Generator
    • NICO Corporation Touts Positive ENRICH Trial Results
    • Study Reveals Graphene-Based Biosensors' Potential in Detecting Critical Biomarker
    View Breaking News >
    CURRENT ISSUE

    June 2023

    • 20 Years: A Discussion on the Past & Future of Medical Product Outsourcing
    • A Combined Effort for Drug Delivery & Combo Product Technology
    • Examining Medical Packaging & Sterilization on Multiple Fronts
    • Medical Molding Modernized
    • 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

    Blue Diamond, Brightseed Partner To Discover New Almond Bioactives
    GOED Publishes Report on EPA and DHA’s Impact on Brain Health
    Alkemist Labs Creates Validated Method for Plant and Fungi-Based Psychedelics
    Coatings World

    Latest Breaking News From Coatings World

    Sandrine Garnier Joins ChemQuest as a Director
    Greenbuild Announces 2023 Keynote Speaker
    PPG’s New Paint for a New Start Initiative to Beautify Schools Worldwide with Colorful Makeovers
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Teleflex’s Wattson temporary pacing guidewire FDA cleared
    PDC Partners with David Schnur Associates to Provide Manufacturing Solutions
    Olympus Releases Next-Gen ESG-410 Electrosurgical Generator
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Lotus Clinical Research, Trialogics Partner for Clinical Trial Software Services
    Qosina, Carolina Components Partner to Market Bioprocess Components
    Astellas, KateTx Enter Exclusive License Agreement to Develop KT430
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    TerraCycle and Wrinkles Schminkles Announces Recycling Program
    Boots CFO Michael Snape Resigns
    Beiersdorf Shares Progress of Its Sustainability Agenda
    Happi

    Latest Breaking News From Happi

    What Chemicals Are Flagged as Washington State Begins Cycle 2 of Safer Products Regulatory Effort
    Hair Growth Composition Patented by J&J
    Superzero's New Social Media Campaign with Song Candy Media Brings Humor to Hair Care
    Ink World

    Latest Breaking News From Ink World

    SICPA Inaugurates Its unlimitrust Campus
    Siegwerk’s Center of Excellence in France Receives Facelift
    Epson announces MakeTheSwitch Campaign
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Gallus to celebrate 100 years, opening new Gallus Experience Center
    Mark Andy holds successful Low Migration Workshop
    Ryback & Ryback Consulting launches Machinery division
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Terra Baby Diapers, Wipes Launch in U.S. and Canada
    The Honest Company to Exit Europe, Asia
    TechnoPlants to Exhibit at ITMA
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Osso VR Launches Virtual Reality Training Program
    Catalyst OrthoScience Names Mark Quick as CFO
    European Regulators Approve Amber Implants' VCFix Spinal System Study
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Sensormatic Unveils Sensormatic Synergy Media Display
    ams OSRAM Receives the German Innovation Award
    ASSA ABLOY Receives Clearance from Mexico for HHI Acquisition

    Copyright © 2023 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