• 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
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    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
    Top News
    January AI Raises $8.8 Million in New Funding

    FDA Clears Ava Fertility Tracking Wearable Device

    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

    Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

    Japan to Lead APAC Assisted Reproductive Technology Devices Market
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    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
    PTI Engineered Plastics Inc.

    Forefront Medical Technology

    Creganna Medical, part of TE Connectivity

    Unicep

    FUTEK Advanced Sensor Technology Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services

    The 8 Major Types of PPE Supply Chain Fraud
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Qosina Corp.

    maxon

    FUTEK Advanced Sensor Technology Inc.

    Creganna Medical, part of TE Connectivity

    Unicep
    • 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
    • Podcasts
    • Resources
    • eBook
    • 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 Approves Cardinal Health's INCRAFT AAA Stent Graft System

    The flexible endovascular aneurysm repair system treats infrarenal abdominal aortic aneurysms.

    Related CONTENT
    • Rapid Growth Expected for Global Smart Syringe Market
    • J. Knipper and Company Adds to its Executive Team
    • Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027
    • Katena Products Welcomes New CEO
    • The Heart of the Matter: Trends in Cardiology
    Cardinal Health11.29.18
    Cordis, a Cardinal Health company announced that the U.S. Food and Drug Administration (FDA) has approved its INCRAFT AAA Stent Graft System for use in complex access anatomies. The INCRAFT system is an ultra-low profile and flexible endovascular aneurysm repair (EVAR) system designed to treat infrarenal abdominal aortic aneurysms (AAA).
     
    The INCRAFT system was given a favorable recommendation on June 12 by a Circulatory System Devices Panel of the Medical Devices Advisory Committee, following a review of clinical data from the pivotal INSPIRATION trial, a prospective, multi-center, single-arm study designed to evaluate the safety and effectiveness of the INCRAFT system in patients with AAA. The trial showed that the INCRAFT system met the primary safety and effectiveness endpoints, with a low rate of major adverse events at 30 days, high rates of successful aneurysm treatment and survival, and no aneurysm ruptures through four years of follow up.
     
    “We welcome the recent FDA approval of the INCRAFT stent graft system which offers U.S. physicians a treatment option for patients with AAAs who otherwise might not be suitable for other EVAR devices,” said Dr. Michel Makaroun, M.D., Professor and Chair of vascular surgery at the University of Pittsburgh Medical Center, and Co-Principal Investigator of the INSPIRATION study. “While EVAR systems have advanced rapidly over the years, there still remains a need for a low-profile EVAR device that is designed to be easy to deliver in complex access anatomies while facilitating precise placement.”
     
    “INCRAFT is an attractive new ultra-low profile EVAR option that allows for bilateral in-situ adjustment during the procedure, helping to minimize the need for additional components or extensions,” said Dr. Takao Ohki, Chairman and Professor of Surgery and Chief of Vascular Surgery at the Jikei University School of Medicine in Tokyo, Japan and Co-Principal Investigator of the INSPIRATION study.
     
    While several EVAR devices are currently available in the U.S., treatment options are limited for many AAA patients with small femoral or iliac arteries or with heavily calcified or tortuous vessels that could lead to complications during the introduction of EVAR devices.
     
    “We are excited to announce INCRAFT FDA approval, which will enable high-risk AAA patients in the U.S. to benefit from more than a decade of investment in R&D and clinical research,” said Patrick Holt, president of Cordis at Cardinal Health. “Cordis continues to invest in expanding our product offering to meet our global customers’ needs, whether via innovations like our Mynx Control Vascular Closure Device and our RADIAL 360 portfolio, or via strategic alliances, which brought the EluNIR drug-eluting coronary stent to the U.S.”
     
    The INCRAFT system, which received a CE (Conformité Européenne) mark in 2014, is commercially available in many global geographies, including Canada and countries in the European Union, the Middle East, South America, and Asia Pacific.
    Related Searches
    • medical
    • president
    • dr
    • surgery
    Related Knowledge Center
    • Cardiovascular
    • Surgical
    Suggested For You
    Rapid Growth Expected for Global Smart Syringe Market Rapid Growth Expected for Global Smart Syringe Market
    J. Knipper and Company Adds to its Executive Team J. Knipper and Company Adds to its Executive Team
    Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027 Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027
    Katena Products Welcomes New CEO Katena Products Welcomes New CEO
    The Heart of the Matter: Trends in Cardiology The Heart of the Matter: Trends in Cardiology
    The Top 30 and M&A in 2021: What’s Next? The Top 30 and M&A in 2021: What’s Next?
    Endologix Receives CE Mark for ALTO Abdominal Stent Graft System Endologix Receives CE Mark for ALTO Abdominal Stent Graft System
    Endologix Launches ALTO Abdominal Stent Graft System in U.S. Endologix Launches ALTO Abdominal Stent Graft System in U.S.
    Abbott Begins Study for New Esprit BTK Fully Resorbable Stent Abbott Begins Study for New Esprit BTK Fully Resorbable Stent
    Stryker Stryker's Neuroform Atlas Stent Approved for Back of the Brain Aneurysms
    Aortic Stent Graft Market Likely to be Negatively Impacted by Pandemic Aortic Stent Graft Market Likely to be Negatively Impacted by Pandemic
    BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test
    FDA OKs ALung Hemolung Respiratory Assist System to Treat COVID-19 FDA OKs ALung Hemolung Respiratory Assist System to Treat COVID-19
    Medtronic Recalls Brain Aneurysm Stents Medtronic Recalls Brain Aneurysm Stents
    Deciphering Dosage: A Focus on Combination Products Deciphering Dosage: A Focus on Combination Products

    Related Breaking News

    • Cardiovascular
      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.
      Michael Barbella, Managing Editor 02.25.21

    • Surgical
      TransEnterix Changes Name to Asensus Surgical

      TransEnterix Changes Name to Asensus Surgical

      The rebranded firm also introduced a new surgical category—performance-guided surgery.
      Sam Brusco, Associate Editor 02.24.21

    • Cardiovascular
      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NCVC in Japan will develop computational models while NTT Research MEI Lab will implement a bio digital twin platform.
      Michael Barbella, Managing Editor 02.24.21


    • Surgical
      FDA Green Lights EPI

      FDA Green Lights EPI's EndoClot Hemostat to Manage GI Bleeding

      Rapidly and reliably controls bleeding during GI procedures.
      Sam Brusco, Associate Editor 02.23.21

    • Cardiovascular
      RSIP Vision Announces New Coronary Artery Segmentation Tool

      RSIP Vision Announces New Coronary Artery Segmentation Tool

      New module utilizes deep learning algorithms combined with classic computer vision methods to create a 3D model of the coronary arteries.
      Charles Sternberg, Assistant Editor 02.18.21

    • Cardiovascular
      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Technology approved to treat calcified coronary plaque.
      Charles Sternberg, Assistant Editor 02.17.21


    • Cardiovascular
      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Informs physicians to cease use of the device until further notice.
      Charles Sternberg, Assistant Editor 02.17.21

    • Cardiovascular | Neurological
      Cerus Endovascular

      Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status

      Indicated for the treatment of intracranial aneurysms.
      Sam Brusco, Associate Editor 02.12.21

    • Cardiovascular
      Vascular Perfusion Solutions

      Vascular Perfusion Solutions' VP.S Encore Cardiac Transport Device Wins Breakthrough Status

      Enables preserving of vascularized tissue for eight hours.
      Sam Brusco, Associate Editor 02.09.21


    • Surgical
      Apollo Endosurgery to Welcome New Leader

      Apollo Endosurgery to Welcome New Leader

      Charles (Chas) McKhann will become CEO of the company on March 1.
      Sam Brusco, Associate Editor 02.08.21

    • Cardiovascular
      Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

      Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

      Data show an 86 percent survival rate for cardiomyopathy cardiogenic shock patients.
      Michael Barbella, Managing Editor 02.08.21

    • Cardiovascular
      FDA Clears Wearable Electrocardiogram Sensor

      FDA Clears Wearable Electrocardiogram Sensor

      The product offers extended ambulatory ECG recording up to three weeks.
      Michael Barbella, Managing Editor 02.08.21


    • Surgical
      J&J Granted FDA Approval for Monofocal IOL

      J&J Granted FDA Approval for Monofocal IOL

      TECNIS Eyhance and TECNIS Eyhance Toric II IOLs help treat cataract patients.
      Sam Brusco, Associate Editor 02.03.21

    • Surgical
      CooperSurgical Buys AEGEA Medical

      CooperSurgical Buys AEGEA Medical

      Gains endometrial ablation treatment that uses water vapor to treat heavy menstrual bleeding.
      Sam Brusco, Associate Editor 02.02.21

    • Cardiovascular | Surgical
      Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

      Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

      There were no incidences of structural valve deterioration at the five-year mark.
      Sam Brusco, Associate Editor 02.01.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • TransEnterix Changes Name To Asensus Surgical
    • An Analysis Of The Smart Inhalers Market
    Breaking News
    • January AI Raises $8.8 Million in New Funding
    • FDA Clears Ava Fertility Tracking Wearable Device
    • First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    • Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably
    • Japan to Lead APAC Assisted Reproductive Technology Devices Market
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • 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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    January AI Raises $8.8 Million in New Funding
    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Top Beauty Products of 2021, According to HelloGiggles
    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Happi

    Latest Breaking News From Happi

    Cosmetic Chemical Sales To Post CAGR 5.8% To 2025
    ACI Urges Senate to Approve Regan as EPA Administrator
    Estée Lauder Signs Actress Ana de Armas
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FTA converts Forum & INFOFLEX to virtual events
    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 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