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 Receives FDA Premarket Approval for Pipeline(R) Embolization Device(3)

April 6, 2011 By Covidien

MANSFIELD, Mass., Apr 06, 2011 (BUSINESS WIRE) —

Covidien (NYSE:COV), a leading global provider of healthcare
products, today announced that it received Premarket Approval (PMA)
from the U.S. Food and Drug Administration (FDA) for the
Pipeline(R) Embolization Device, 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.

Pipeline is a new class of embolization device designed to
divert blood flow away from the aneurysm in order to provide a
complete and durable aneurysm embolization while maintaining
patency of the parent vessel.

A cerebral aneurysm is a weak spot in the wall of a blood vessel
within the brain, characterized by an abnormal “ballooning” or
widening of the vessel. A brain aneurysm ruptures every 18 minutes
and 40% of these cases are fatal. Of those who survive, about 66%
suffer some permanent neurological deficit.1

“The Pipeline Embolization Device is a breakthrough and
life-saving endovascular treatment for large or giant wide-neck
brain aneurysms,” said Joe Woody, President, Vascular Therapies,
Covidien. “Pipeline now offers hope for those patients who have had
no other options for treating this often debilitating and even
fatal medical condition.”

The Pipeline Embolization Device PMA application was based on
the results of the PUFS (Pipeline for Uncoilable or Failed
Aneurysms) clinical study, a single-arm study of large and giant,
wide-neck or fusiform aneurysms that included safety and efficacy
data on 108 patients.

“Brain aneurysms are a silent killer because most show no
symptoms over time,” said Christine Buckley, Executive Director,
The Brain Aneurysm Foundation. “The Pipeline Embolization Device
now provides patients with a safe and effective treatment of large
or giant, wide-neck aneurysms, which remained an unmet clinical
need until now.”

The Pipeline Embolization Device has received CE Mark approval
in Europe and has been sold outside the United States since July
2009. The Pipeline device will be available at the existing
clinical sites in the U.S. beginning this quarter.

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 approximately 42,000 employees worldwide in
more than 60 countries, and its products are sold in over 140
countries. Please visit
www.covidien.com
to learn more about our business.

1Brain Aneurysm Foundation.
http://www.bafound.org/Statistics_and_Facts

Photos/Multimedia Gallery Available:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6674623&lang=en

SOURCE

Related Articles Read More >

A portrait of ResMed President and COO Rob Douglas
ResMed finds a solution to semiconductor shortage, as well as some humor in it
Johnson & Johnson Office of Digital Innovation Leader Peter Schulam
Imagining the future of cloud-connected medical devices with Johnson & Johnson leaders
Withings Body Scan
Withings plans launch for Body Scan smart scale platform
BinaxNow COVID-19 Ag Card
Time recognizes Abbott offerings among this year’s 100 best inventions

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