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

Off-Label Use Of Stryker Wingspan Stent Could Pose Serious Risks: US FDA

Executive Summary

The agency issued a recent safety alert against off-label use of Stryker’s Wingspan Stent. Based on a postmarket study, regulators found higher rates of stroke and death in patients who were treated with the stent for other than its approved indication.

You may also be interested in...



ISC 2018: WEAVE Post-Market Data Boost Stryker's Wingspan Brain Stent

Stryker's Wingspan intracranial stent, the subject of controversy several years ago when a post-market trial showed an unexpectedly high risk of adverse events with the device, can be deployed effectively with minimal risk in the specific patient population indicated on its label, results of the WEAVE study show.

FDA Narrows Indication For Stryker’s Wingspan Intracranial Stent

Agency restricts use of the device to a select patient population with severe intracranial stenosis and recurrent stroke after reviewing studies indicating the device could actually lead to increased rates of stroke and death.

News We’re Watching: Lung Preservation System Goes National, De Novo For MMI, Brazil’s ANVISA To Recognize Overseas Approvals

This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT125028

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