Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Covidien Launches Study To Expand Indication For Pipeline Aneurysm Device

This article was originally published in The Gray Sheet

Executive Summary

The firm hopes to support approval for use of the embolization device for smaller aneurysms and in more anatomical locations with data from its just-launched PREMIER trial. Also, Covidien announced the first patient in a new registry to track postmarket data, and hopefully support reimbursement, for its mechanical thrombectomy stroke devices including Solitaire 2.

You may also be interested in...



FDA Panel To Weigh In On Neuro Flow Diverter Device Studies

The agency's Neurological Devices Panel will provide recommendations on study design and data analysis issues for flow diverter devices for aneurysms in April.

Covidien Initiates Aneurysm Device Recall

The voluntary recall of Covidien’s Pipeline aneurysm embolization device and Alligator retrieval devices is expected to have a slight negative effect on earnings in the second half of the year, but the impact could increase if it takes longer than expected to replace the affected products, the firm suggested.

Covidien Plans April U.S. Launch Of Solitaire For Ischemic Strokes

Clot removal device gains 510(k) clearance earlier than expected, will compete with Stryker’s Merci clot retrieval system.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033316

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel