• 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
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    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
    TransMed7 Achieves First-in-Human for Heron Soft Tissue Biopsy Devices

    West Pharmaceutical Services Invests in Latch Medical

    Integra LifeSciences Founder Dr. Richard Caruso Passes Away

    NeuroVasc Technologies Begins Treating Patients in Stent Retriever Trial

    Probo Medical Buys Mi Healthcare
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    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

    Arthur G. Russell Co. Inc., The

    Xact Wire EDM Corp.

    JBC Technologies

    Trademark Plastics Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Medical Computing: COM Express Processes Real-Time Data at the Edge

    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things

    Leveraging Open Healthcare Data Standards to Improve Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    Arthur G. Russell Co. Inc., The

    Xact Wire EDM Corp.

    JBC Technologies

    Trademark Plastics Inc.
    • 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

    B. Braun Interventional Systems Receives Breakthrough Device Designation Status for SeQuent

    SeQuent Please ReX is the latest generation coronary drug-coated balloon (DCB) catheter developed by the company.

    Related CONTENT
    • B. Braun Integrates Infusion Pump Systems With TeleTracking Technologies Tracking Solution
    • Philips & B. Braun Release Onvision Needle Tip Tracking
    • B. Braun Integrates Space Infusion Pumps with GuardRFID's Asset Tracking Solution
    • B. Braun's SeQuent Please ReX Drug-Coated PTCA Balloon Catheter Wins Breakthrough Status
    • The 2019 Top 30 Global Medical Device Companies
    Globe Newswire09.26.19
    B. Braun Interventional Systems Inc. (BIS) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis (ISR).
     
    SeQuent Please ReX is the latest generation coronary drug-coated balloon (DCB) catheter developed by B. Braun, the worldwide market leader in drug-coated PTCA catheters. Ten years of clinical study evaluations have been conducted on SeQuent Please drug-coated PTCA catheters and the data were reported in peer-reviewed articles. These studies have evaluated use of the catheters in a variety of indications, including in-stent restenosis for bare metal stents (BMS) and drug-eluting stents (DES), as well as for initial stenosis detected in de novo lesions. 
     
    In-stent restenosis is the gradual re-narrowing of a coronary artery following stent implantation, and remains a challenge in the interventional community. Despite a significant reduction in ISR when using a drug-eluting stent over a bare metal stent, there still are a subset of patients in which ISR persists. Approximately 5 percent of patients who receive a DES and more than 30 percent of patients who undergo BMS implantation experience ISR.1
     
    “We need to have a coronary DCB in our toolbox to treat patients,” said Dr. Jorge Saucedo, chief of Cardiology at the Medical College of Wisconsin, “This Breakthrough Device Designation brings the technology a step closer for our use.”
     
    Breakthrough Device Designation from the FDA is granted to certain medical devices and device-led combination products that provide for a more effective treatment of life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance and de novo marketing authorization.
     
    “The paclitaxel-coated SeQuent Please PTCA balloon catheter has a proven track record of safety and efficacy for BMS- and DES-ISR in randomized clinical trials as well as in the largest international DCB registry with a clinical endpoint. This device is the gold standard coronary DCB based on the available clinical evidence,” said Peter Flosdorf, engineering manager at B. Braun Interventional Systems. “We are excited that the latest generation SeQuent Please DCB has received Breakthrough Device Designation, which will streamline the review process and timeline for bringing this important treatment option to appropriate patients in the U.S.”
     
    B. Braun Interventional Systems offers interventional solutions designed with the patient in mind. Many of the products offered have been developed in response to the needs of physicians, technicians, and nurses. The company is committed to delivering safety, precision and convenience to interventional procedures. B. Braun Interventional Systems Inc. is part of the B. Braun Group of Companies in the United States, which is headquartered in Bethlehem, Pa., and includes B. Braun Medical Inc., Aesculap, and CAPS.
     
    Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs.

    Reference
    1 Byrne R et al. Eur Heart J. 2015; 36(47): 3320-31 | Buccheri D et al. J Thorac Dis. 2016; 8(10): E1150-62
     
     
    Related Searches
    • track
    • standards
    • Medical Devices
    • clearance
    Suggested For You
    B. Braun Integrates Infusion Pump Systems With TeleTracking Technologies Tracking Solution B. Braun Integrates Infusion Pump Systems With TeleTracking Technologies Tracking Solution
    Philips & B. Braun Release Onvision Needle Tip Tracking Philips & B. Braun Release Onvision Needle Tip Tracking
    B. Braun Integrates Space Infusion Pumps with GuardRFID B. Braun Integrates Space Infusion Pumps with GuardRFID's Asset Tracking Solution
    B. Braun B. Braun's SeQuent Please ReX Drug-Coated PTCA Balloon Catheter Wins Breakthrough Status
    The 2019 Top 30 Global Medical Device Companies The 2019 Top 30 Global Medical Device Companies
    15. B. Braun 15. B. Braun
    B. Braun Interventional Launches NuDEL All-in-One Stent Delivery System B. Braun Interventional Launches NuDEL All-in-One Stent Delivery System
    B. Braun Inks Distribution Deal for Nexus TKO-6P Luer Activated Anti-Reflux Device B. Braun Inks Distribution Deal for Nexus TKO-6P Luer Activated Anti-Reflux Device
    B. Braun Launches First FDA-Approved Heparin Sodium Prefilled Syringe with Attached Safety Needle B. Braun Launches First FDA-Approved Heparin Sodium Prefilled Syringe with Attached Safety Needle
    B. Braun Medical Acquires NxStage Medical Inc.’s Streamline Bloodlines B. Braun Medical Acquires NxStage Medical Inc.’s Streamline Bloodlines
    Once or Again? Single-Use Products Are Gaining Attention Once or Again? Single-Use Products Are Gaining Attention

    Related Breaking News

    • B. Braun Integrates Infusion Pump Systems With TeleTracking Technologies Tracking Solution

      B. Braun Integrates Infusion Pump Systems With TeleTracking Technologies Tracking Solution

      The collaboration between the two companies follows IHE standards.
      Globe Newswire 09.19.19

    • Philips & B. Braun Release Onvision Needle Tip Tracking

      Philips & B. Braun Release Onvision Needle Tip Tracking

      Integrated point-of-care solution allows anesthesiologists to perform regional anesthesia procedures, like peripheral nerve blocks, more safely and efficiently.
      Philips 09.10.19

    • Software & IT
      B. Braun Integrates Space Infusion Pumps with GuardRFID

      B. Braun Integrates Space Infusion Pumps with GuardRFID's Asset Tracking Solution

      The collaboration between B. Braun and GuardRFID follows IHE standards and includes a bi-directional interface capability.
      GlobeNewswire 08.09.19


    • Cardiovascular | Surgical
      B. Braun

      B. Braun's SeQuent Please ReX Drug-Coated PTCA Balloon Catheter Wins Breakthrough Status

      SeQuent Please ReX is the latest generation coronary drug-coated balloon (DCB) catheter developed by B. Braun.
      GlobeNewswire 08.02.19

    • The 2019 Top 30 Global Medical Device Companies

      The 2019 Top 30 Global Medical Device Companies

      ...
      Sean Fenske, Michael Barbella, & Sam Brusco, MPO Editorial Staff 07.30.19

    Loading, Please Wait..

    Trending
    • Diabetes Care Devices Market To Top $87B By 2030
    • Boston Scientific Nabs Obsidio, Boosts Embolization Portfolio
    • Microneedle Patch Glucose Monitor Proves Virtually Painless And More Accurate
    • The Future Of Biomedical Engineering Advancements
    • Philips CEO Frans Van Houten To Step Down
    Breaking News
    • TransMed7 Achieves First-in-Human for Heron Soft Tissue Biopsy Devices
    • West Pharmaceutical Services Invests in Latch Medical
    • Integra LifeSciences Founder Dr. Richard Caruso Passes Away
    • NeuroVasc Technologies Begins Treating Patients in Stent Retriever Trial
    • Probo Medical Buys Mi Healthcare
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • 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

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome
    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression
    Coatings World

    Latest Breaking News From Coatings World

    Vining Ivy: GLIDDEN Paint by PPG’s ‘is 2023 Color of the Year
    Indorama Ventures Posts Record 2Q 2022 Results
    Advanced Polymer Coatings Strikes Series of New Tanker Deals
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    TransMed7 Achieves First-in-Human for Heron Soft Tissue Biopsy Devices
    West Pharmaceutical Services Invests in Latch Medical
    Integra LifeSciences Founder Dr. Richard Caruso Passes Away
    Contract Pharma

    Latest Breaking News From Contract Pharma

    WuXi Advanced Therapies Enters Licensing Agreement with Janssen
    U.S. Alliance Pharma Expands Early Phase Bioanalytical Services
    BioDuro-Sundia and X-Chem Enter Partnership
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Johnson & Johnson to Discontinue Global Sales of Talc-Based Baby Powder
    Dr. Squatch To Launch a 2nd Star Wars Soap Collection
    Neopac Wins 2 European Tube Manufacturers Association Awards
    Happi

    Latest Breaking News From Happi

    Japonesque Acquires Foot Care Brand Barefoot Scientist
    Inolex Launches New Cannabis-Derived Ingredient for Sustainable Conditioning and Emulsification
    PLZ Personal Care Makes Key Leadership Appointments
    Ink World

    Latest Breaking News From Ink World

    BASF Breaks Ground on Riverfront Park in East Newark
    Roland DG Corporation to Relocate HQ to Miyakoda, Japan
    Gallus Launches Gallus One, Its First Fully Digital Inkjet Label Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FINAT reports decrease in labelstock consumption during first half of 2022
    Color-Logic partners to feature metallics at autumn events
    New Era Converting Machinery heads to The Battery Show
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Tranzonic Acquired by Private Investment Firm
    Monadnock Earns EcoVadis Gold Rating
    Suominen Announces Price Surcharges
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Integra LifeSciences Founder Dr. Richard Caruso Passes Away
    FDA Clears CTL Amedica's Navigation Instrument System
    FundamentalVR Raises $20 Million in Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    onsemi Celebrates Expansion of Silicon Carbide Production Facility in New Hampshire
    Applied Materials CTO Dr. Om Nalamasu Receives IEEE Frederik Philips Award
    Weekly Recap: ALTANA, Universal Display and Emerson Top This Week’s Stories

    Copyright © 2022 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