• 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
    MPO's Most-Read Stories This Week—Sept. 30

    Dentsply Sirona Names Former NuVasive CEO Lucier as Chairman

    SeaStar Medical Gets Breakthrough Nod for Selective Cytopheretic Device

    ResMed, Nyxoah Team Up to Grow Sleep Apnea Awareness & Therapy in Germany

    Siemens Healthineers’ Magnetom Viato.Mobile Cleared by FDA
    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.

    Providence Enterprise USA Inc.

    Cirtec Medical

    Halkey-Roberts Corporation

    Medbio LLC
    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.

    Providence Enterprise USA Inc.

    Cirtec Medical

    Halkey-Roberts Corporation

    Medbio LLC
    • 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

    FDA Broadens ClearGuard HD Antimicrobial Barrier Cap Indications

    Caps have been shown to reduce central line-associated bloodstream infections in hemodialysis patients.

    FDA Broadens ClearGuard HD Antimicrobial Barrier Cap Indications
    The ClearGuard HD Antimicrobial Barrier Cap is the first and only device cleared for sale in the United States that kills infection-causing bacteria inside a long-term hemodialysis catheter hub. Image courtesy of Pursuit Vascular Inc.
    PR Newswire07.11.18
    Pursuit Vascular Inc., manufacturer of ClearGuard HD Antimicrobial Caps, the leading antimicrobial device for catheter-based dialysis patients, said the U.S. Food and Drug Administration (FDA) granted clearance for a broader indication of the company’s ClearGuard HD caps to include reduction in the incidence of central-line associated bloodstream infection (CLABSI) in hemodialysis patients with central venous catheters (CVCs). The safety and efficacy of the ClearGuard technology is well established, and ClearGuard HD caps were first cleared for use with hemodialysis catheters in 2013.  The expanded clearance was based on post-market clinical surveillance data.
     
    Bloodstream infection is the leading cause for hospitalizations and the second leading cause of death in hemodialysis patients, and catheters cause 70 percent of these infections. The ClearGuard HD cap is the first and only device cleared for sale in the United States that kills infection-causing bacteria inside a long-term catheter.  The caps are simple to use, yet highly effective and clinically shown to reduce bloodstream infection. 
     
    The expanded clinical indications are a result of a recent study published in the April 2018 Journal of the American Society of Nephrology.  The study, conducted by DaVita Clinical Research, demonstrated that use of ClearGuard caps vs. Tego Connector plus Curos caps, lowered the rate of BSIs in hemodialysis patients using CVCs. The study builds on prior research conducted by Frenova Renal Research (Fresenius Kidney Care), published in 2017 in the American Journal of Kidney Diseases, demonstrating that use of ClearGuard HD caps vs. standard CVC caps lowered the rate of BSIs in hemodialysis patients using CVCs. 
     
    “Bloodstream infections can have a devastating effect on patients and contribute significantly to healthcare costs for insurers and patients,” said Doug Killion, president and CEO of Pursuit Vascular. “Dialysis patients are particularly vulnerable to infections, and ClearGuard HD caps represent a lifesaving tool that have a real impact on these patients’ lives.”
     
    The ClearGuard HD Antimicrobial Barrier Cap is the first and only device cleared for sale in the United States that kills infection-causing bacteria inside a long-term hemodialysis catheter. The caps are simple to use and clinically shown to reduce central line-associated bloodstream infection.  This simple, yet revolutionary single-use device is protected by seven issued U.S. patents, and several other U.S. patents pending. Foreign patents issued and pending.
     
    Headquartered in Maple Grove, Minn., Pursuit Vascular Inc. is developing a family of products designed to protect patients from acquiring life-threatening infections associated with long-term catheter and port use, while reducing the costs of healthcare.
    Related Searches
    • president
    • manufacturer
    • first
    • fda
    Suggested For You
    Europe Europe's Needle-free IV Connectors Market to Top $442.5 Million by 2027
    TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System
    BD Acquires TVA Medical to Advance Chronic Kidney Disease Solutions BD Acquires TVA Medical to Advance Chronic Kidney Disease Solutions
    FDA OKs First Catheter-Based Systems to Create Vascular Access for Hemodialysis Patients FDA OKs First Catheter-Based Systems to Create Vascular Access for Hemodialysis Patients
    FDA Approves Medtronic FDA Approves Medtronic's 200 & 250mm IN.PACT Admiral Drug Coated Balloons
    Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry
    The Human Cyborg, Circa 2033 The Human Cyborg, Circa 2033
    3 Critical Considerations for U.S. Medical Device Commercialization 3 Critical Considerations for U.S. Medical Device Commercialization
    IRIDEX Appoints Two New Members to its Board IRIDEX Appoints Two New Members to its Board
    FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
    Software Validation: How It Should Be Done Software Validation: How It Should Be Done
    FDA FDA's Expansion of 510(k) Program Seeks to End Predicate Testing for Some Devices
    Natural Tissue-Growing Implant Helps Treat Chronic Kidney Disease Natural Tissue-Growing Implant Helps Treat Chronic Kidney Disease
    Alere to Pay U.S. $33.2M to Settle Allegations of Unreliable Diagnostic Testing Devices Alere to Pay U.S. $33.2M to Settle Allegations of Unreliable Diagnostic Testing Devices
    Monteris Medical NeuroBlate System Recalled Over Unexpected Laser Delivery Probe Heating Monteris Medical NeuroBlate System Recalled Over Unexpected Laser Delivery Probe Heating

    Related Breaking News

    • Europe

      Europe's Needle-free IV Connectors Market to Top $442.5 Million by 2027

      Product approvals and launches are expected to drive growth over the next six years.
      Michael Barbella, Managing Editor 05.10.21

    • TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System

      TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System

      Company receives clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy procedures.
      Business Wire 07.10.18

    • Surgical
      BD Acquires TVA Medical to Advance Chronic Kidney Disease Solutions

      BD Acquires TVA Medical to Advance Chronic Kidney Disease Solutions

      TVA Medical's everlinQ endoAVF System also received FDA De Novo marketing authorization.
      PR Newswire 07.09.18


    • Cardiovascular | Surgical
      FDA OKs First Catheter-Based Systems to Create Vascular Access for Hemodialysis Patients

      FDA OKs First Catheter-Based Systems to Create Vascular Access for Hemodialysis Patients

      The Ellipsys Vascular Access System and everlinQ endoAVF System are designed to create AV fistulas percutaneously.
      U.S. Food and Drug Administration 06.25.18

    • Cardiovascular | Surgical
      FDA Approves Medtronic

      FDA Approves Medtronic's 200 & 250mm IN.PACT Admiral Drug Coated Balloons

      New, extended balloon lengths enable physicians to efficiently treat long SFA lesions.
      GlobeNewswire 06.15.18

    Loading, Please Wait..

    Trending
    • ZOLL Expands Temperature Management Portfolio To Include IQool System
    • A New Approach To Post-Market Surveillance
    • Siemens Healthineers Presents Mammomat B.brilliant
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
    Breaking News
    • MPO's Most-Read Stories This Week—Sept. 30
    • Dentsply Sirona Names Former NuVasive CEO Lucier as Chairman
    • SeaStar Medical Gets Breakthrough Nod for Selective Cytopheretic Device
    • ResMed, Nyxoah Team Up to Grow Sleep Apnea Awareness & Therapy in Germany
    • Siemens Healthineers’ Magnetom Viato.Mobile Cleared by FDA
    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

    D2C Supplement Brand Launches Blood Sugar Support Supplement, Gluco-Control
    Natrol Launches First Non-Melatonin Sleep Supplement
    Metagenics Releases Consumer Survey on Menopausal Support Supplement
    Coatings World

    Latest Breaking News From Coatings World

    BASF Donates $5,000 to High School STEAM Education Programs in Chattanooga Area
    Coating Additives Market Worth $10.5B by 2028: MarketsandMarkets
    California Sports Surfaces Celebrates 70 Years
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—Sept. 30
    Dentsply Sirona Names Former NuVasive CEO Lucier as Chairman
    SeaStar Medical Gets Breakthrough Nod for Selective Cytopheretic Device
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Univercells Expands into the U.S. With New Offices in Andover, MA
    Evecxia Therapeutics, Quotient Sciences Complete Clinical Milestone for Depression Treatment
    Ionis, Roche Partner on RNA-targeted Programs for AD and HD
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    ScentAir Debuts Room Sprays & More
    African Pride Launches On-Campus Activations
    Sharper Image Debuts Revel Hair Tools
    Happi

    Latest Breaking News From Happi

    Hair Searches in the US Change ‘Coarse’ with Growing Demand for Textured Hair Solutions
    Boss Bottled Celebrates 25th Anniversary
    In the Case of Efficacious Cosmetic Buys, Cost is Not A Factor Says Mintel
    Ink World

    Latest Breaking News From Ink World

    W+D to Premiere i-Jet 3 Inkjet at Printing United
    MicroDynamics, All Printing Resources Partner to Represent Veritas
    Weekly Recap: Wikoff Color, BASF, Latin America Top This Week’s Stories
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    TLMI's LLT grows, Labelexpo Europe details big numbers and more
    SABIC and partners launch bio-based IML solution for food packaging
    tesa completes expansion of Michigan manufacturing facility
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Thomas Receives INDA Lifetime Technical Service Award, ExxonMobil Works with JL Goor
    Greentech Introduces Air Filter with Advanced Odor Elimination
    Ontex Divests Pakistan Operations to ASAIA Holding
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—Sept. 30
    Lazurite Adds Benchmark Medical as a Distributor for its ArthroFree Wireless Camera System
    ChitogenX Granted New U.S., Canadian ORTHO-R Patent
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Mergers and Acquisitions, First Solar Top This Week’s Stories
    Jabil Posts Fourth Quarter, Fiscal Year 2023 Results
    Ink-Borne ‘Chiplets’ Could Lead to Printable Displays, Electronics and More

    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