• Resources
  • Blog
  • Journalists
  • Log In
  • Sign Up
  • Data Privacy
  • Send a Release
Cision PR Newswire: news distribution, targeting and monitoring home
  • News
  • Products
    • Overview
    • Distribution by PR Newswire
    • Cision Communications Cloud®
    • Cision IR
    • All Products
  • Contact
    • General Inquiries
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • Media Inquiries
    • Worldwide Offices

 

When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases
      • All News Releases
      • All Public Company
      • English-only


      • News Releases Overview
      • Multimedia Gallery
      • All Multimedia
      • All Photos
      • All Videos


      • Multimedia Gallery Overview
      • Trending Topics
      • All Trending Topics


  • Business & Money
      • Auto & Transportation
      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation


      • Auto & Transportation Overview
      • Business Technology
      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors


      • Business Technology Overview
      • Entertain­ment & Media
      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • Entertain­ment & Media Overview
      • Financial Services & Investing
      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Stock Offering
      • Stock Split
      • Venture Capital


      • Financial Services & Investing Overview
      • General Business
      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News


      • General Business Overview
  • Science & Tech
      • Consumer Technology
      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications


      • Consumer Technology Overview
      • Energy & Natural Resources
      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities


      • Energy & Natural Resources Overview
      • Environ­ment
      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters


      • Environ­ment Overview
      • Heavy Industry & Manufacturing
      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco


      • Heavy Industry & Manufacturing Overview
      • Telecomm­unications
      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications


      • Telecomm­unications Overview
  • Lifestyle & Health
      • Consumer Products & Retail
      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys


      • Consumer Products & Retail Overview
      • Entertain­ment & Media
      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • Entertain­ment & Media Overview
      • Health
      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine


      • Health Overview
      • Sports
      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories


      • Sports Overview
      • Travel
      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry


      • Travel Overview
  • Policy & Public Interest
      • Policy & Public Interest
      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy


      • Policy & Public Interest Overview
  • People & Culture
      • People & Culture
      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women


      • People & Culture Overview
      • In-Language News

      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO

      Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Policy & Public Interest
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • People & Culture
    • People & Culture
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR

Cerus Endovascular Receives FDA Breakthrough Device Designation for its Contour Neurovascular System™


News provided by

Cerus Endovascular Ltd.

Feb 11, 2021, 08:03 ET

Share this article

Share this article


FREMONT, Calif. and OXFORD, United Kingdom, Feb. 11, 2021 /PRNewswire/ -- Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System™.

Breakthrough Device Designation is granted to medical devices and device-led combination products that provide the potential for a more effective treatment option for life-threatening or irreversibly debilitating diseases. The designation expedites the traditional development, assessment and review process, and enables medical professionals to get access to new developments quickly.

Indicated for the treatment of intracranial aneurysms, the Contour Neurovascular System™, composed of fine mesh braid, represents a unique intrasaccular advancement in the market, as it targets the neck of the aneurysm, away from the vulnerable dome. Additionally, the System is designed to be self-anchored for stability, re-sheathable for precise placement, and because it is deployed across the neck, sizing criteria are less restrictive than other commercially available intrasaccular devices, making it easier to use in the clinical setting.

"Today's news marks another significant milestone in our company's evolution and is the direct result of the commitment and strength of our scientific team, led by Dr. Lori Adels, Chief Compliance Officer," stated Dr. Stephen Griffin, President of Cerus Endovascular. "We anticipate initiating our U.S. clinical trial, under an Investigational Device Exemption, soon and will work aggressively to bring our already CE Mark-approved Contour technology to the U.S. market."

"We look forward to working with U.S. regulatory authorities to expedite the availability of this innovative device that could provide an effective, minimally invasive treatment for bifurcated, intracranial aneurysms, a life threatening condition," noted Dr. Adels. "Under this program, the FDA will provide us with timely, interactive communication, priority review and FDA senior management engagement regarding the development of efficient and flexible clinical trial protocols, through to commercialization strategy and decisions."

Dr. Sam Milstein, Cerus' Chairman, added, "International sales of the Contour System continue to accelerate, as the medical communities abroad recognize the tangible benefits of this device. We look forward to having a similar impact in the U.S. market."

About Cerus Endovascular

Cerus Endovascular is a privately held, commercial-stage, medical device company engaged in the design and development of highly differentiated and proprietary interventional neuroradiology devices and delivery systems for the treatment of acute, life-threatening neurological conditions, specifically, intracranial aneurysms. The Company's CE Marked products, the Contour Neurovascular System™ and the Neqstent Coil Assisted Flow Diverter, expand the number and types of treatable intracranial aneurysms. For more information, please go to: www.cerusendo.com.

Contacts:
Melody A. Carey
Rx Communications Group, LLC
917-322-2571
[email protected] 

SOURCE Cerus Endovascular Ltd.

Related Links

https://www.cerusendo.com/

Modal title

Also from this source

Cerus Endovascular Announces the First Ever Robotic Assist...

Explore

More news releases in similar topics

  • Health Care & Hospitals
  • Medical Equipment
  • Medical Pharmaceuticals
  • FDA Approval
  • FDA Approval

    Contact Cision

  • Cision Distribution 888-776-0942
    from 8 AM - 9 PM ET

  • Chat with an Expert
    • General Inquiries
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • Media Inquiries
    • Worldwide Offices

    Products

  • Cision Communication Cloud®
  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • For Small Business
  • All Products

    About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • COVID-19 Resources
  • Accessibility Statement

    • Asia
    • Brazil
    • Canada
    • Czech
    • Denmark
    • Finland
    • France
    • Germany
    • India
    • Israel
    • Italy
    • Mexico
    • Middle East
    • Netherlands
    • Norway
    • Poland
    • Portugal
    • Russia
    • Slovakia
    • Spain
    • Sweden
    • United Kingdom

    My Services

  • All New Releases
  • Online Member Center
  • ProfNet

Contact Cision


Products


About


My Services
  • All News Releases
  • Online Member Center
  • ProfNet℠
Cision Distribution Helpline
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2021 Cision US Inc.