Printer Friendly

Piper sees minimal impact from FDA review of paclitaxel coated devices.

The FDA on Friday afternoon updated healthcare providers on its review of paclitaxel coated devices, which include Medtronic's (MDT) IN.PACT DCB and Boston Scientific's (BSX) Eluvia DES, Piper Jaffray analyst Matt O'Brien tells investors in a research note. In their pooled post-approval analysis, the FDA found ~50% increased risk of crude mortality compared to control devices and will be convening a panel to analyze this issue further, adds the analyst. He points out that the FDA is also recommending providers monitor patients who have received the devices and encouraging these providers to consider alternatives where the risks may outweigh the benefits. While this data is concerning, the result is "unsurprising given that many of these patients were included in the meta-analysis," contends O'Brien. Further, experts at the ISET 2019 conference in January were unconvinced about this connection to mortality, and a poll of the several hundred interventionists in the room indicated that it is unlikely to dampen usage in the interim, he says. As such, the analyst expects the FDA impact to have a minimal impact.

COPYRIGHT 2019 The Fly
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2019 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:The Fly
Date:Mar 18, 2019
Previous Article:Muddy Waters comments on Boeing after Seattle Times story.
Next Article:Worldpay jumps 11% to $109.14 following $43B merger with FIS.

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters