• 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
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    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
    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA

    LifeQ Unveils New 24-Hour Sleep Solution

    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll

    EvoEndo Names CEO and Chief Operating Officer

    Electromedical Products International Forms Scientific Advisory Board
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    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
    JBC Technologies

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The

    Cirtec Medical

    Medbio LLC
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    JBC Technologies

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The

    Cirtec Medical

    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

    Lombard Medical Receives Japanese Regulatory Approval for IntelliFlex LP Delivery System

    Japanese partner Medico’s Hirata anticipates market share gain following launch early this year.

    Business Wire01.06.17
    Lombard Medical Inc., developer of endovascular aneurysm repair (EVAR) technology for abdominal aortic aneurysms (AAAs), has received approval from the Japanese Ministry of Health, Labour and Welfare for its IntelliFlex Low Profile (LP) Delivery System for the Aorfix Endovascular Stent Graft. Commercial launch will follow reimbursement approval, which is anticipated in February 2017.
     
    Aorfix with IntelliFlex is exclusively distributed by Medico's Hirata Inc., one of Japan’s leading suppliers of vascular products with proven expertise in building significant market share for AAA stent grafts.
     
    This new delivery system is used in conjunction with the Aorfix endovascular stent graft, the only AAA stent graft with global regulatory approval to treat aortic neck angulation up to 90 degrees. The IntelliFlex LP Delivery System features a low profile, compact and ergonomic design that provides intuitive control of Aorfix during deployment, even in challenging anatomy. The system features an integrated exchange sheath allowing ancillary devices to be introduced during the endovascular AAA procedure avoiding the need for sheath exchanges thus potentially reducing blood loss, vessel trauma, procedure cost and time.

    “We have enjoyed great success already with Aorfix in Japan and built our market share to approximately 8 percent over the last two years," said Masataka Hirata, president of Medico’s Hirata Inc. Now with the approval of IntelliFlex, we believe we will significantly increase the usage of this unique technology for the benefit of physician’s ease of use, procedural outcomes and patients across the broadest range of AAA anatomies.”

    Aorfix is an endovascular stent graft system for treating infra-renal aortic and aorto-iliac aneurysms, also known as abdominal aortic aneurysms (AAAs). When placed within the aneurysm, Aorfix creates an internal bypass of the aneurysm to reduce the risk of rupture. Aorfix is the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees. Aorfix features an exclusive helical and circular design that allows it to conform to the natural contours of human anatomy, including aortic necks with high angulations and iliac arteries with extreme bends. Aorfix has been evaluated in three studies and used in more than 7,000 procedures worldwide. Aorfix has a CE Mark, Japan regulatory approval, and received U.S. Food and Drug Administration approval in 2013.
     
    AAAs are balloon-like enlargements of the aorta which if left untreated, may rupture and cause death. Approximately 4.5 million people are living with AAAs in the developed world and each year more than 500,000 new cases are diagnosed. In the United States, aortic aneurysm disease is among the leading causes of death and it is estimated that 1.5 million people have an abdominal aortic aneurysm.
     
    “Japan is the world’s second largest standalone EVAR market and is both strategically and financially important for us,” said Lombard Medical CEO Simon Hubbert. “With our partner, Medico’s Hirata, we look forward to providing Japanese physicians with the Aorfix stent graft, which has outstanding clinical results, now delivered with the unique advantages of the IntelliFlex LP Delivery System.”
     
    The EVAR market in Japan is estimated at 10 percent of the global market and has been growing at an average rate of approximately 18 percent. In Japan, there are approximately 400 physicians at 200 clinics performing EVAR and it is estimated that approximately 55 percent of Japanese AAA patients are treated using this method.1
     
    Business Update
    The Company is reporting preliminary revenue of $2.4 million for the 2016 fourth quarter and $12.1 million for the 2016 full year as compared to the most recent guidance provided in August 2016 which reflected a revenue floor of $13 million. Underlying this shortfall is the company’s previously stated strategy to exit the U.S. market and to pursue cash conservation measures to bridge the business to the recently announced transaction with MicroPort Scientific Corporation.
     
    Lombard Medical Inc. is an Oxfordshire, United Kingdom-based medical device company focused on the $1.8 billion market for minimally invasive treatment of abdominal aortic aneurysms (AAAs). The company has global regulatory approval for Aorfix, an endovascular stent graft that has been specifically designed to treat patients with the broadest range of AAA anatomies, including aortic neck angulation up to 90 degrees. The company has also achieved CE Mark for the Altura endograft system, an innovative ultra-low profile endovascular stent graft that offers a simple and predictable solution for the treatment of more standard AAA anatomies.

    Reference:
    1. Medtech Ventures: Aortic Intervention Market (2014)
    Related Searches
    • u.s. food and drug administration
    • ce mark
    • aaa
    • standard
    Related Knowledge Center
    • R&D & Design
    Suggested For You
    First Patient Enrolled and Treated in Lombard Medical First Patient Enrolled and Treated in Lombard Medical's ALTITUDE Registry for the Altura Stent Graft
    FDA Designates N8 Medical FDA Designates N8 Medical's CeraShield Endotracheal Tube as a Breakthrough Device
    Lombard Medical Appoints New CEO Lombard Medical Appoints New CEO
    FDA Clears First Whole Slide Imaging System for Digital Pathology FDA Clears First Whole Slide Imaging System for Digital Pathology
    Collaborating on Custom Materials Development Collaborating on Custom Materials Development
    Extractable/Leachable Chemistry Testing Strategies for Medical Devices Extractable/Leachable Chemistry Testing Strategies for Medical Devices
    Four Common Misperceptions of Accelerated FDA Approval Four Common Misperceptions of Accelerated FDA Approval
    FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device
     FlowAid Receives FDA Clearance for the FA100 SCCD FlowAid Receives FDA Clearance for the FA100 SCCD
    Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use
    FDA Clears Voxello FDA Clears Voxello's Speech Generation Device
    Accuray Radixact System Receives Japanese Shonin Approval Accuray Radixact System Receives Japanese Shonin Approval
    Lombard Medical Completes First 15 Cases in Japan for IntelliFlex LP Delivery System Lombard Medical Completes First 15 Cases in Japan for IntelliFlex LP Delivery System
    Lombard Medical, MicroPort Scientific Corporation Forge Strategic Partnership Lombard Medical, MicroPort Scientific Corporation Forge Strategic Partnership

    Related Breaking News

    • Cardiovascular
      First Patient Enrolled and Treated in Lombard Medical

      First Patient Enrolled and Treated in Lombard Medical's ALTITUDE Registry for the Altura Stent Graft

      Trial will evaluate the use of the Altura Endograft System in 1,000 patients in typical clinical-use conditions.
      Business Wire 05.26.17

    • FDA Designates N8 Medical

      FDA Designates N8 Medical's CeraShield Endotracheal Tube as a Breakthrough Device

      Device is a specially-modified endotracheal tube coated with a proprietary ceragenin compound formulation.
      N8 Medical LLC 04.24.17

    • Cardiovascular
      Lombard Medical Appoints New CEO

      Lombard Medical Appoints New CEO

      Kurt Lemvigh held senior positions at Spacelabs, Cardiac Science, GE, and Marquette-Hellige.
      Business Wire 04.24.17


    • Diagnostics | Digital Health | Electronics | Software & IT
      FDA Clears First Whole Slide Imaging System for Digital Pathology

      FDA Clears First Whole Slide Imaging System for Digital Pathology

      Philips IntelliSite Pathology Solution cleared for primary diagnostic use.
      U.S. Food and Drug Administration 04.13.17

    • Materials | R&D & Design
      Collaborating on Custom Materials Development

      Collaborating on Custom Materials Development

      OEMs and contractors can engage with materials suppliers for custom formulations and product development.
      Deepak Prakash, Vancive Medical Technologies 04.03.17

    Loading, Please Wait..

    Trending
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • FDA Clears Sanara MedTech's Advanced Surgical Solution
    • Titan Medical Licenses Most IP To Intuitive; CEO Steps Down
    Breaking News
    • CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    • LifeQ Unveils New 24-Hour Sleep Solution
    • Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    • EvoEndo Names CEO and Chief Operating Officer
    • Electromedical Products International Forms Scientific Advisory Board
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • 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

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    Teal and Mackrill Director Geoff Mackrill Honored by BCF
    Evonik's TEGO Airex 923 Wins 2023 Ringier Technology Innovation Award
    120 Years HOFFMANN MINERAL - Success Through Innovation and Responsibility
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    LifeQ Unveils New 24-Hour Sleep Solution
    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    Contract Pharma

    Latest Breaking News From Contract Pharma

    WuXi Increases Manufacturing Capacity in Germany
    Quanticate, KPS Life Partner to Advance Clinical Research
    Sterling Joins Partnership to Advance AI Flow Chemistry Techniques
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal North Asia President Discusses China's Consumer Sector Recovery & Premium Beauty Trends
    Kiehl’s Celebrates Pride by Supporting The Trevor Project
    L’Oréal & UNESCO Announce 2023 Laureates of the For Women in Science International Awards
    Happi

    Latest Breaking News From Happi

    Beauty & Wellness Brand Veracity Hires Chief Hormone Officer
    Skincare Brand Three Ships Beauty Expands Retail Partnership With Whole Foods
    Uoma Beauty Founder and CEO Sharon Chuter Steps Down
    Ink World

    Latest Breaking News From Ink World

    Mactac Acquires Canadian Roll Label Distributor Label Supply
    WestRock Advances its Commitment to a Sustainable Future
    Roland DGA Announces Key Service Department Personnel Changes
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Appvion announces new, sustainable coatings for label facestocks
    Epson teams with 5 Gyres Institute to battle plastic pollution
    Maxcess opens new facility in India
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Harper Hygienics Launches Hemp-Based Intimate Care Wipes
    What You’re Reading on Nonwovens-Industry.com
    Biodiapers Signs Agreement with Sicam
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Augmedics Debuts New Features, Indications for xvision Platform
    Artelon Closes $20M Series B Funding
    Orthofix Unveils Seven-Year Outcome Data for M6-C Artificial Cervical Disc
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    DIC Acquires Photoresist Polymers Manufacturer PCAS Canada
    Arkema Collaborates with Habitat for Humanity Philadelphia
    Vitesco Technologies, onsemi Sign SiC Long-Term Supply Agreement

    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