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

Covidien Announces Data on Pipeline(R) Embolization Device for Uncoilable or Failed Aneurysms

July 27, 2011 By Covidien

Clinical study shows device safety and
effectiveness

COLORADO SPRINGS, Colo., Jul 27, 2011 (BUSINESS WIRE) —


Covidien
(NYSE:COV), a leading global provider of healthcare
products, today announced the results of the PUFS (Pipeline for Uncoilable or Failed AneurysmS) clinical study at the Society of
NeuroInterventional Surgery 8th Annual Meeting here.

PUFS is a single-arm, 108-patient study of large and giant,
wide-neck aneurysms or fusiform typically not coilable, with
positive six-month safety and effectiveness endpoints. The
Pipeline(R) Embolization Device, the first product in a
new class, received Premarket Approval in April 2011 and is
indicated for the endovascular treatment of adults (22 years of age
or older) with large or giant wide-necked intracranial aneurysms in
the internal carotid artery from the petrous to the superior
hypophyseal segments.

In summary, the Pipeline Embolization Device met the trial
primary endpoints for both effectiveness and safety. The efficacy
endpoint was pre-determined to be a success if the results were
statistically greater than 50% compared to actual results of 73.6%
(p-value <.0001). Efficacy was defined as complete aneurysms
occlusion at 180 days without major parent vessel stenosis and
without the use of other treatments. The safety endpoint was
pre-determined to be a success if the results were statistically
less than 20% compared to actual results of 5.6% (p-value
<.0001). Safety was defined as major ipsilateral stroke or
neurologic death at 180 days.

“The Pipeline Device redefines the treatment of uncoilable and
failed aneurysms,” said Joe Woody, President, Vascular Therapies,
Covidien. “The positive results of the PUFS trial further validate
the safety and efficacy of this device for patients.”

The Pipeline Embolization Device consists of two main mechanisms
of action: flow diversion, in which the Pipeline Device disrupts
the flow of blood from the parent artery into the aneurysm, and
re-endothelialization, where the Pipeline Device forms a scaffold
upon which endothelial cells can grow. Full coverage of the implant
with endothelial cells, including over the neck of the intracranial
aneurysm, seals the aneurysm fundus from the parent artery,
minimizing the risk of rupture, as well as recanalization.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that
creates innovative medical solutions for better patient outcomes
and delivers value through clinical leadership and excellence.
Covidien manufactures, distributes and services a diverse range of
industry-leading product lines in three segments: Medical Devices,
Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4
billion, Covidien has 41,000 employees worldwide in more than 65
countries, and its products are sold in over 140 countries. Please
visit
www.covidien.com
to learn more about our business.

SOURCE

Related Articles Read More >

Engineer inspecting artificial hip joint parts in quality control department in orthopaedic factory
Deburring and finishing for beautiful, functional medical devices
A Medtronic HVAD pump opened up to show the inner workings
FDA designates new Medtronic HVAD pump implant recall as Class I
Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age

DeviceTalks Weekly.

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
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