• 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
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    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
    The Acrotec Group Acquires Friedrich Daniels

    Siemens Healthineers Presents Mammomat B.brilliant

    MCRA Expands Biocompatibility Division With Board-Certified Toxicologist Hire

    ISO 13485 Certification Awarded to Inspira Technologies

    ZOLL Expands Temperature Management Portfolio to Include IQool System
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Back to School for Medical Device Cybersecurity Training

    Driving Clinical Trial Excellence to Help Study Teams Run a Faster Relay Race

    Medtech’s Supply Chain: From Disruption to Opportunity

    Are Medtech’s Mega-Deals Gone For Good?

    Will a Skilling Gap Hinder Organizational Readiness for Medtech’s New Age of AI?
    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
    LEMO USA Inc.

    NDH Medical Inc.

    Halkey-Roberts Corporation

    The Arthur G Russell Company

    JBC Technologies
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Wearables Are Changing the Way We Collect Real-World Data in Clinical Trials

    Could Medtech Ever Stop a Hospital Killer in Their Tracks?

    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    NDH Medical Inc.

    Halkey-Roberts Corporation

    The Arthur G Russell Company

    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

    Successful First Human Use of Foldex's Biopolymer Mitral Heart Valve

    Second product from Tria Biopolymer Valve portfolio to move into human study.

    Business Wire07.30.21
    Foldax Inc. has announced the successful first-in-human use of its biopolymer Tria heart valve in surgically replacing a diseased mitral valve. The first case was performed by David Heimansohn, M.D., at Ascension St. Vincent Hospital, Indianapolis, as part of a U.S. early feasibility research study.
     
    “We are excited to be the first center in the world to implant the innovative Tria mitral valve as part of this research study. In this first-in-man procedure, we saw an immediate improvement in the functionality of this patient’s heart valve once the valve was in place,” said Dr. Heimansohn. “Since it has been designed to be a more durable artificial valve that may not require lifetime anti-coagulation therapy, it is hoped that Tria will be proven effective through this research study for patients with mitral disease, who are often much younger than patients with other valvular diseases.”
     
    The Tria valves reimagine the heart valve by incorporating a new, proprietary biopolymer—LifePolymer—with innovative valve designs intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants. Tria is also the first and only heart valve to be robotically produced, which is possible due to its polymer leaflets that can be consistently manufactured with precise thicknesses and are designed to achieve a valve with predictable performance that lasts a lifetime.
     
    The need for mitral valve replacement is expected to grow significantly into the future, driven by a steady increase in the prevalence of rheumatic heart disease, which is the main cause of mitral valve stenosis and affects more than 40 million people worldwide.1
    The Tria heart valve is considered investigational in the United States and is not available for commercial sale in the United States.

    “We thank Dr. Heimansohn and his skilled team at Ascension St. Vincent Hospital for their commitment to advancing cardiovascular medicine by successfully performing the first-in-man Tria mitral valve procedure,” said Foldax CEO Frank Maguire. “This milestone continues to build upon the clinical evidence supporting Foldax’s Tria valves, which includes the ongoing Tria aortic valve study encompassing several patients who have celebrated one year with their implants and are doing well. Our transcatheter aortic valve replacement (TAVR) continues its rapid development path and will give us both surgical and transcatheter approaches in our family of heart valves. Foldax intends to revolutionize the heart valve replacement market by largely solving the durability, quality of life and manufacturing issues that have vexed the clinical community and industry for decades.”
     
    Headquartered in Salt Lake City, Utah, Foldax is reinventing every aspect of the heart valve—from material to design to manufacturing—to develop surgical and transcatheter valves designed to last a lifetime addressing historical tradeoffs. Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures.

    Reference 
    1 Roth GA, Mensah GA, Johnson CO, et al. Global burden of cardiovascular diseases and risk factors, 1990-2019: Update from the GBD 2019 study. JACC. 2020 December;76(25):2982-3021.
    Related Searches
    • Cardiovascular
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Nissha Medical Technologies Nissha Medical Technologies
    Simbex Simbex
    Hobson & Motzer Inc. Hobson & Motzer Inc.
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    RedDress’ ActiGraft System Receives New FDA Clearance RedDress’ ActiGraft System Receives New FDA Clearance
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021 MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    CareDx Appoints Hannah Valantine to its Board CareDx Appoints Hannah Valantine to its Board
    Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products
    FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests
    Babson Diagnostics Raises $31 Million in Series B Funding Babson Diagnostics Raises $31 Million in Series B Funding
    FDA Clears Inova Diagnostics FDA Clears Inova Diagnostics' Digital Multi-Analyte System
    FDA Approves Abbott FDA Approves Abbott's Portico with FlexNav TAVR System

    Related Buyers Guide Companies

    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 11.18.22

    • Simbex

      ...
      Greg Lange, Chief Business Development Officer 10.05.22

    • Hobson & Motzer Inc.

      Hobson & Motzer Inc.

      ...
      Anthony Bracale, Director, Sales & Marketing 09.28.22


    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
      Business Wire 09.22.21

    Loading, Please Wait..

    Trending
    • ZOLL Expands Temperature Management Portfolio To Include IQool System
    • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
    • Cardiosense Begins SEISMIC-HF I Heart Failure Trial
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • ProPublica Investigation Claims Philips Kept CPAP Issues From The FDA For 11 Years
    Breaking News
    • Steve Ward Named Executive VP and CFO at Perosphere Technologies
    • India Regulators Approve BaroPace's PressurePace Clinical Trial
    • Double-Digit Growth Forecast for Australian Telehealth Devices Market
    • The Acrotec Group Acquires Friedrich Daniels
    • Siemens Healthineers Presents Mammomat B.brilliant
    View Breaking News >
    CURRENT ISSUE

    October 2023

    • MPO's 2023 Medtech Supply Chain Survey
    • Exceeding Medical Device Extrusion Expectations
    • Medical Device Micromolders Discuss the 'Minor Details'
    • 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

    PLT Health Solutions Granted Claims for Botanical Ingredient in Canada
    CRN Files Petition with FTC For Clarity on Health Products Compliance Guidance
    Vitafoods Europe Relocates to Barcelona Starting 2025
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Shares Sustainable Architectural Solutions at Conference
    PPG and Dutch University to Develop World's First Off-Road Solar Car
    Selektope Keeps Global Mercy’s Hull Barnacle-Free
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    The Acrotec Group Acquires Friedrich Daniels
    Siemens Healthineers Presents Mammomat B.brilliant
    MCRA Expands Biocompatibility Division With Board-Certified Toxicologist Hire
    Contract Pharma

    Latest Breaking News From Contract Pharma

    BioCity, AstraZeneca Partner on Treatment of Advanced HCC
    Sartorius, SPARTA Biodiscovery Partner on Nanoparticle Analysis Platform
    Peptone Expands Leadership Team with Key Executive Hires
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    74% of Makeup Users Open to Affordable ‘Dupes,’ Mintel Says
    Stoelzle Glass Group Names New CEO
    Estée Lauder Executive Pay Packages Fall in Fiscal 2023
    Happi

    Latest Breaking News From Happi

    Breakfast with Oral Care Benefits?
    Stanford Researchers Study Skin and Sensorial Perception
    L’Oréal Awarded US Patent for Makeup
    Ink World

    Latest Breaking News From Ink World

    Amcor plc Adds Lucrèce Foufopoulos-De Ridder to Board of Directors
    Arkema Accelerates Its Organic Growth
    Toyo Printing Inks Participating in Eurasia Packaging Istanbul Fair
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Spinnaker's Troy manufacturing site earns ISO 9001:2015 certification
    APR publishes expanded Global Design Catalog
    Anjou adds Bobst Digital Master 340
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Ontex Divests Pakistan Operations to ASAIA Holding
    Goodnites Bedwetting Underwear Recognized by Good Housekeeping
    Ed Thomas Receives INDA Lifetime Technical Service Award
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Centinel Spine prodisc System Surpasses 2,500-Implant Milestone
    Medacta Completes First U.S. MyPAO Hip Surgery
    FDA OKs Acuitive's Resorbable CITRELOCK DUO to Repair Bicep Tears
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Ink-Borne ‘Chiplets’ Could Lead to Printable Displays, Electronics and More
    SCHOTT Strengthens Glass Substrate Portfolio
    Emerson Ventures Invests in First Resonance

    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