Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Cardinal Health Announces FDA Approval Of The INCRAFT AAA Stent Graft System

December 5, 2018 By Cardinal Health

Cordis, a Cardinal Health company, recently announced that FDA approval of 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 in June 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,” says Michel Makaroun, MD, 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.”

(Image credit: Cardinal Health)

“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,” says 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,” says 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 ControlTM Vascular Closure Device and our RADIAL 360 portfolio, or via strategic alliances, which brought the EluNIRTM 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 Articles Read More >

Avail Medsystems
How Avail Medsystems seeks to create a connected OR experience
Engineer inspecting artificial hip joint parts in quality control department in orthopaedic factory
Deburring and finishing for beautiful, functional medical devices
FDA logo
FDA seeking innovations to move beyond heater-cooler device problems
Logos of Creo Medical and Intuitive
Creo Medical inks collaboration agreement with Intuitive

DeviceTalks Weekly.

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech