Accessibility Statement Skip Navigation
  • Resources
  • Investor Relations
  • Journalists
  • Agencies
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
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

      • View All Auto & Transportation

      • 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

      • View All Business Technology

      • Entertain­ment & Media

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

      • View All Entertain­ment & Media

      • 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
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • Financial Services & Investing Overview

      • View All Financial Services & Investing

      • General Business

      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • 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

      • View All General Business

  • 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

      • View All Consumer Technology

      • 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

      • View All Energy & Natural Resources

      • Environ­ment

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

      • View All Environ­ment

      • 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

      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

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

      • View All Telecomm­unications

  • 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

      • View All Consumer Products & Retail

      • Entertain­ment & Media

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

      • View All Entertain­ment & Media

      • 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

      • View All Health

      • Sports

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

      • View All Sports

      • Travel

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

      • View All Travel

  • 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

      • View All Policy & Public Interest

  • 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

      • View All People & Culture

      • In-Language News

      • Arabic
      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Explore Our Platform
  • Plan Campaigns
  • Create with AI
  • Distribute Press Releases
  • Amplify Content
  • All Products
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Hamburger menu
  • 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
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • Explore Our Platform
  • Plan Campaigns
  • Create with AI
  • Distribute Press Releases
  • Amplify Content
  • All Products
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS

Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.
  • USA - Deutsch
  • India - English
  • Latin America - español
  • USA - español
  • USA - Français
  • Brazil - Português

Occlutech International Logo

News provided by

Occlutech International

Aug 16, 2021, 02:00 ET

Share this article

Share toX

Share this article

Share toX

SCHAFFHAUSEN, Switzerland, Aug. 16, 2021 /PRNewswire/ -- Occlutech Holding AG ("Occlutech"), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration ("FDA") approval of its Investigational Device Exemption ("IDE") application to conduct a pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale ("PFO") closure by Occlutech's Flex II PFO Occluder to the standard of care for PFO occlusion in patients with cryptogenic stroke.

Occlutech today announces that the FDA has conditionally granted Occlutech an IDE for a prospective, randomized, multi-center, controlled, clinical study ("OCCLUFLEX"), which aims to compare outcomes of PFO closure by Occlutech's Flex II PFO Occluder to the standard of care in patients with cryptogenic stroke.

The IDE allows Occlutech's PFO Occluder to be used in a clinical study to collect safety and effectiveness data to support a Premarket Approval ("PMA"). This marks a key milestone in Occlutech's strategy of capturing the significant U.S. market opportunity for the PFO Occluder, which today has regulatory approvals in over 60 markets.

Sabine Bois, CEO Occlutech, comments:

"The conditional FDA approval is another significant milestone in our plan to enter the U.S. Accounting for approximately 30 percent of the global Structural Heart Defect occluder market, and characterized by an attractive pricing and reimbursement system, the U.S. is a potential key market for Occlutech. Earlier this year we set up a subsidiary in Chicago, focusing on marketing, distribution, logistics and sales. We expect to complete the enrollment of patients in 2025 while finalizing the Premarket Approval and anticipate to receive an FDA market approval for the U.S. in 2026."

Patient enrollment is expected to commence during the second half of 2021. The study's primary and secondary endpoints, PFO Closure and recurrent stroke, respectively, will be evaluated at the 12-month patient follow-up.

About PFO

PFO is a common structural heart defect in which the foramen ovale does not seal completely after birth, resulting in a flap opening between the left and right atria of the heart. PFOs occurs in approximately 25 percent of the general population.[1]

Blood clots that commonly develop outside the heart may pass directly through the PFO from the right atrium without passing through the lungs, where they are normally filtered out of the blood. Such clots may cause an occlusion of a small blood vessel and, if located in the brain, cause a stroke.

Occlutech's Flex II PFO Occluder, which has regulatory approvals in over 60 markets globally, enables physicians to close the Patent Foramen Ovale through a minimally invasive procedure. Occlutech's PFO Occluder is proven and effective for stroke prevention, reducing the relative risk of recurrent stroke by 97 percent.[2] The mean procedure time for PFO closure is less than 30 minutes with decreased fluoroscopic time[3] (X-ray exposure), contributing to the device's excellent track-record of performance and safety.[4]

For additional information about the Company's products, the Occlutech PFO Occluder, or to inquire about participation in our patient registries, please visit Occlutech's website at www.occlutech.com, or contact us directly at [email protected].

About Occlutech

Occlutech is a leading provider of minimally invasive structural heart disease devices. Occlutech develops, manufactures, and commercializes structural heart and interatrial shunt products to improve the treatment of patients. Occlutech has a broad and proven portfolio, with more than 135,000 products sold, addressing congenital defects, stroke prevention and heart failure. Occlutech markets and sells its structural heart and interatrial shunt products to hospitals and clinics in approximately 85 countries through its direct sales organization and international network of distribution partners. Occlutech has approximately 250 employees and maintains manufacturing and R&D facilities in Jena, Germany and Istanbul, Turkey, with a global supply and customer support hub located in Helsingborg, Sweden.

Contact

Claudia Scalia
Marketing Communications Manager
Tel: +46 735 199782  
[email protected]

Stefan Kleidon
Vice President Sales & Marketing
Tel: +49 176 31514136  
[email protected]

[1] Krasuski, R. (2017). Closure of Patent Foramen Ovale After Stroke: Who Benefits? [PowerPoint presentation]. SlideShare. https://www.slideshare.net/DukeHeartCenter/closure-of-patent-foramen-ovale-after-stroke-who-benefits

[2] Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke Mas et al. (N Engl J Med 2017; 377:1011-1021).

[3] Trabattoni, D., Gaspardone, A., Sgueglia, G. A., Fabbiocchi, F., Gioffrè, G., Montorsi, P., Calligaris, G., Iamele, M., De Santis, A., & Bartorelli, A. L. (2017). AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 12(17), 2092–2099. https://doi.org/10.4244/EIJ-D-15-00499

[4] Snijder, R., Renes, L. E., Suttorp, M. J., Ten Berg, J. M., & Post, M. C. (2019). Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient-years of follow up. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 93(6), 1080–1084. https://doi.org/10.1002/ccd.27984

Logo - https://mma.prnewswire.com/media/1522595/Occlutech_International_AB_Logo.jpg

SOURCE Occlutech International

WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?

icon3
440k+
Newsrooms &
Influencers
icon1
9k+
Digital Media
Outlets
icon2
270k+
Journalists
Opted In
GET STARTED

Modal title

Contact PR Newswire

  • Call PR Newswire at 888-776-0942
    from 8 AM - 9 PM ET
  • Chat with an Expert
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices

Products

  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Italy
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom
  • Vietnam

My Services

  • All New Releases
  • Platform Login
  • ProfNet
  • Data Privacy

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Platform Login
  • ProfNet
Call PR Newswire at
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookies
Copyright © 2025 Cision US Inc.