• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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—June 25

    Magnetic Insight Announces $17 Million in Series B Funding

    BreatheSuite Adds Brad Fluegel to its Board

    Labcorp Launches At-Home Collection Device for Diabetes Risk Testing

    Thirona, Free Flow Medical Partner on COPD Solutions
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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
    Concise Engineering

    Arthur G. Russell Co. Inc., The

    JBC Technologies

    Xact Wire EDM Corp.

    BMP Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques

    How MedTech Professionals Can Help Combat Physician Burnout

    How to Optimize Manufacturing Lines and Choose Which Machines to Buy

    How Are Hypodermic Needles Made?
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Concise Engineering

    Arthur G. Russell Co. Inc., The

    JBC Technologies

    Xact Wire EDM Corp.

    BMP Medical
    • 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

    PQ Bypass Announces CE Mark for DETOUR Percutaneous Bypass Technologies

    Technologies expand treatment options for patients with extremely long superficial femoral artery blockages.

    Related CONTENT
    • Is Your Biocompatibility Program on the Edge?
    • New 510(k) Approach Would Leverage FDA Objective Criteria
    • FDA Clears CrossBay Medical's IVF Embryo Transfer Catheter Set
    • FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers
    • Industry Offers Support for Gottlieb Confirmation
    Business Wire03.24.17
    PQ Bypass has received CE (Conformité Européenne) Mark approval for a trio of proprietary devices: TORUS Stent Graft System, PQ Snare, and PQ Crossing Device, which enables physicians to perform a fully percutaneous femoral-popliteal bypass in patients with TransAtlantic InterSociety (TASC) II C and D lesions in the superficial femoral artery due to peripheral artery disease (PAD).
     
    More than 200 million people worldwide are affected by PAD, which is a potentially life-threatening condition.1 In complex PAD, arteries in the leg become blocked by extremely long segments of plaque, restricting blood flow to the lower extremities. This can lead to pain, loss of mobility and amputation. Historically, extremely long blockages were treated by open bypass surgery, however experts now consider an endovascular-first approach. While standard endovascular approaches decrease procedure morbidity associated with surgery, they have not yet demonstrated the durability of open bypass surgery.2 The DETOUR procedure, pioneered by PQ Bypass, is designed to match or exceed the durable patency associated with open surgical bypass, but achieve those results with a minimally invasive endovascular procedure that allows rapid return to full function.
     
    The TORUS Stent Graft System is an expanded polytetrafluoroethylene (ePTFE) covered self-expanding nitinol stent intended to improve blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic TASC II C and D lesions. The PQ Snare and PQ Crossing Devices are intended for the retrieval and manipulation of atraumatic foreign bodies in the distal peripheral vasculature and to support the placement and positioning of guidewires in the peripheral vasculature, respectively.
     
    “There is a great unmet need for a durable percutaneous option for these patients with extremely long blockages in the legs due to PAD,” said Dr. Sean Lyden, chairman of the Robert and Suzanne Tomsich Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute. “While other percutaneous approaches have been attempted, long-term success and patency have been difficult to achieve, resulting in limited options for these patients.”
     
    The CE Mark approval was based on data collected in DETOUR I, a prospective, multi-center, core-lab reviewed single-arm trial designed to evaluate the safety and efficacy of the PQ DETOUR procedure in patients with TASC II C and D total occlusions in the femoral-popliteal anatomy. The six-month results from DETOUR I, which were presented in January at the Leipzig Interventional Course (LINC 2017), met both primary safety and effectiveness endpoints.
     
    “The PQ DETOUR procedure is a truly new and innovative approach to treating patients with extremely long SFA lesions,” said Dainis Krievins, M.D., Ph.D., professor of vascular surgery at the University of Latvia, and director, Institute of Research of Pauls Stradins Clinical University Hospital in Riga, Latvia, and investigator in the DETOUR I study. “The initial safety and effectiveness of the DETOUR procedure, as shown in the DETOUR I trial, is very encouraging and the results clearly demonstrate the potential for this to become a key addition to the treatment armamentarium for patients with complex PAD.”
     
    The PQ DETOUR procedure is a fully-percutaneous femoral-popliteal bypass procedure. Using fluoroscopic guidance, a series of proprietary TORUS Stent Grafts are deployed from the popliteal artery into the femoral vein, and from the femoral vein into the superficial femoral artery in a continuous, overlapping fashion through two independent anastomoses. The final result is a large lumen, endograft bypass that delivers unobstructed, pulsatile flow from the SFA ostium to the popliteal artery, restoring blood flow to the lower extremities.
     
    “With an increased focus on value-based and patient-centered medicine, surgical advancements that minimize trauma to patients, reduce length of hospital stay and recovery times are critical global needs,” said Peter Wehrly, president and CEO of PQ Bypass. “CE Mark is an important milestone for PQ Bypass and we look forward to continuing our clinical studies, including an upcoming IDE study, with an eye toward FDA approval. Data presented at LINC 2017 demonstrated that the DETOUR procedure has clear potential as a viable change in how extremely long SFA occlusive disease is treated in the future.”
     
    PQ Bypass Inc. is a Silicon Valley-based firm developing treatments for long-segment peripheral artery disease using minimally-invasive endovascular solutions. The underlying technology and technique used in the percutaneous PQ DETOUR procedure were co-developed by two world-renowned cardiologists and innovators, Dr. James Joye and Dr. Richard Heuser, who are recognized experts in PAD. The PQ Bypass technology platform is not available for sale in the United States.

    References:
    1. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE,Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382:1329–1340. doi: 10.1016/S0140-6736(13)61249-0
    2. Alber M, Romiti M, Brochado-Neto FC, et al. Meta-analysis of alternate autologous veins bypass grafts to infrapopliteal arteries. J Vasc Surg. 2005;42:449-55.
    Related Searches
    • forward
    • surgery
    • data
    • dr
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Is Your Biocompatibility Program on the Edge? Is Your Biocompatibility Program on the Edge?
    New 510(k) Approach Would Leverage FDA Objective Criteria New 510(k) Approach Would Leverage FDA Objective Criteria
    FDA Clears CrossBay Medical FDA Clears CrossBay Medical's IVF Embryo Transfer Catheter Set
    FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers
    Industry Offers Support for Gottlieb Confirmation Industry Offers Support for Gottlieb Confirmation
    FDA Approves First First Flexible Shaver for Interventional Gastroenterology FDA Approves First First Flexible Shaver for Interventional Gastroenterology
     Endologix Announces Enrollment of First Patients in ELEVATE IDE Clinical Study Endologix Announces Enrollment of First Patients in ELEVATE IDE Clinical Study
    Synaptive Medical Expands Board of Directors Synaptive Medical Expands Board of Directors
    CE Mark for Medtronic’s Next Generation CRT Pacemakers CE Mark for Medtronic’s Next Generation CRT Pacemakers
    QT Vascular Inks Deal with Medtronic for Chocolate PTA Catheter QT Vascular Inks Deal with Medtronic for Chocolate PTA Catheter
    Avinger Announces 24-Month Outcomes from the Pivotal VISION Study Avinger Announces 24-Month Outcomes from the Pivotal VISION Study
     PQ Bypass Announces Positive Results From DETOUR I Study PQ Bypass Announces Positive Results From DETOUR I Study
    FDA Approves First Balloon Expandable Stent Graft for Iliac Artery FDA Approves First Balloon Expandable Stent Graft for Iliac Artery

    Related Online Exclusives

    • Testing
      Is Your Biocompatibility Program on the Edge?

      Is Your Biocompatibility Program on the Edge?

      Regulatory changes in both Europe and the U.S. have created uncertainty among device makers.
      Thor Rollins, B.S., RN (NRCM), Senior Scientist, Nelson Laboratories 05.18.17

    • New 510(k) Approach Would Leverage FDA Objective Criteria

      New 510(k) Approach Would Leverage FDA Objective Criteria

      AdvaMed president issues statement in support of new legislation.
      Advanced Medical Technology Association 05.18.17

    • FDA Clears CrossBay Medical

      FDA Clears CrossBay Medical's IVF Embryo Transfer Catheter Set

      The device has also received clearance to commercialize the product in Europe by obtaining its CE mark.
      PR Newswire 05.18.17


    • Cardiovascular
      FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers

      FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers

      Portfolio of heart failure devices offers effective pacing and access to the most advanced diagnostic imaging procedures.
      Medtronic plc 05.11.17

    • Industry Offers Support for Gottlieb Confirmation

      Industry Offers Support for Gottlieb Confirmation

      Dr. Gottlieb previously served as the FDA’s deputy commissioner for medical and scientific affairs.
      Sean Fenske, Editor 05.10.17


    Trending
    • Intermountain Healthcare & Siemens Healthineers Open 3 Tellica Outpatient Imaging Centers
    • Magnetic Insight Announces $17 Million In Series B Funding
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Thermo Fisher Scientific, Bio-Techne Develop Kidney Rejection Test
    • The Power Of Leveraging Customer Relationships
    Breaking News
    • MPO's Most Read Stories This Week—June 25
    • Magnetic Insight Announces $17 Million in Series B Funding
    • BreatheSuite Adds Brad Fluegel to its Board
    • Labcorp Launches At-Home Collection Device for Diabetes Risk Testing
    • Thirona, Free Flow Medical Partner on COPD Solutions
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    Florida Food Products Acquires Javo
    Roquette Launches Nutralys Rice Protein
    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    Coatings World

    Latest Breaking News From Coatings World

    The Southern Society for Coatings Technology's 84th Annual Technical Conference A Success
    PPG to Showcase Specialty Automotive, Aerospace Adhesives, Sealants at Adhesives & Bonding Expo
    PPG’s New Paint for a New Start Initiative to Transform 25-plus Schools Worldwide
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most Read Stories This Week—June 25
    Magnetic Insight Announces $17 Million in Series B Funding
    BreatheSuite Adds Brad Fluegel to its Board
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pierre Fabre and Lonza Enter Manufacturing Agreement
    MasterControl and Elemental Machines Form Biomanufacturing Partnership
    Qosina Strengthens Aseptic Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Benefit Exec Joins Madison Reed's Board
    Peroni & Ellis Brooklyn Launch Fragrance Collection Inspired by Italian Spritz Cocktails
    Rhode Is Trending for June, Trendalytics Says
    Happi

    Latest Breaking News From Happi

    A Suitor Emerges for Revlon, SK Capital’s New Dealmaker & P&G’s Indoor Air Quality Efforts
    Wonder Curl Wins GlossWire's GlossPitch Competition
    Anti-aging Skincare Brand Vitabrid C12 Launches Bestsellers on Amazon
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    British Coatings Federation Posts Online History
    Orion Announces Price Increases, Reduced Payment Terms
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PCMC teams with IGT, Fujifilm makes big announcement and more
    Loftware recognized as 'AIDC Company of the Year'
    Schreiner MediPharm highlights sustainability of Needle-Trap technology
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Tranzonic Names VP of Supply Chain
    Ontex Climate Action Targets Approved by Science-Based Targets Initiative
    Suominen Test Center Assesses Biodegradability of Nonwovens
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 25
    3Spine Inc. Receives IDE Approval for U.S. Pivotal Clinical Trial
    Volume-Based Procurement to Reduce Chinese Orthopedic Market Value
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories
    NREL Names Jennifer Logan to Leadership Team as CFO
    National Grid Renewables Orders 2 GW of First Solar Modules

    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