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

Advisors Provide Lukewarm Endorsement Of St. Jude's PFO Occluder For Stroke

This article was originally published in The Gray Sheet

Executive Summary

FDA's Circulatory System Devices Panel said that St. Jude's Amplatzer PFO closure device has benefits that outweigh risks to prevent recurrent stroke in a select group of patients on an 11-5 vote, despite having missed its primary endpoint in the pivotal RESPECT trial.

You may also be interested in...



Diagnostics A Bright Spot In Lackluster US Interventional Cardiology Market

The US Market for interventional cardiology products, which includes diagnostic and therapeutic products, is anticipated to expand from an estimated $3.3 billion in 2015 to roughly $3.6 billion in total product sales by the year 2020. One bright spot in this otherwise lackluster market is the interventional diagnostic products segment, which is projected to grow at CAGR of 4.7% and reach almost $1 billion by 2020, according to a report by Medtech Insight.

St. Jude Hopes Its PFO Occluder Gets RESPECT At May FDA Panel

St. Jude won a May panel date for its Amplatzer patent foreman ovale occluder PMA, seeking approval to prevent recurrent stroke. It's been a challenging path to this point after the firm's pivotal RESPECT trial did not meet its primary endpoint in 2012.

RESPECT And PC Trial Results In, But Still No Real ‘Closure’ On PFO

There was some expectation leading up to TCT that the two trials could provide a definitive ruling on whether the PFO closure procedure had a future or not. But actual outcomes sparked a range of interpretations.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

MT034818

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