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

Third Panel’s The Charm For Watchman? More Delays For Boston Sci’s Stroke Device

This article was originally published in The Gray Sheet

Executive Summary

FDA has requested that a PMA for Boston Scientific’s Watchman left atrial appendage closure device for stroke-prevention be subject to another advisory panel meeting -- the third since 2009 -- which will delay the launch to, at earliest, the first half of 2015, the company says.

You may also be interested in...



LAA Closure Devices At The Tipping Point

Since the FDA approval of Boston Scientific Corp.'s WATCHMAN device in March, the US market for left atrial appendage closure devices has reached a tipping point. With first-to-market advantage in the US, and a four- to five-year lead on the competition in bringing a LAAC device to the US market, BSX is well positioned to gain a strong foothold in this potentially billion dollar plus market; however, several factors will dictate market adoption of these devices in the US, including reimbursement, clinical efficacy, cost and ease of use.

More Data Challenges For Boston Sci’s Watchman In Lead-Up To Latest Panel

Boston Scientific’s Watchman left-atrial appendage occluder for reducing stroke risk in patients at risk for thromboembolism missed both co-primary efficacy endpoints in the latest follow-up data from the PREVAIL study, but at least one analyst believes it still has a good chance of earning another endorsement from an FDA advisory panel in October. And metaanalysis data offered more support.

Boston Scientific’s Watchman LAA Closer Returns To Advisory Panel

The FDA Circulatory System Devices Advisory Panel will review Boston Scientific Corp.’s Watchman Left Atrial Appendage Closure Technology and, separately, make recommendations on a group of allograft heart valves at an Oct. 8-9 panel meeting in Gaithersburg, Md.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033098

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