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

FDA Tells Providers To Limit Use Of Paclitaxel-Coated Stents

Executive Summary

New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.

You may also be interested in...



Newer Data Fades Paclitaxel Risk, Physician Group Says

A meta-analysis that seemed to show an increased mortality risk tied to paclitaxel-coated balloons and stents sent shockwaves through the device industry last year. But a more complete data review funded by nonprofit group VIVA Physicians may show that the issue has been overestimated.

FDA Announces More Actions On Drug-Coated Devices

The US FDA’s latest update on the safety of paclitaxel-coated balloons and stents urges additional clinical trials. The agency also plans updates to device labeling and clinical trial informed consent documents that will reflect evidence that the devices may pose a mortality risk.

CMS Weighs Merits Of New Pass-Through Payments For Aquabeam System, Eluvia Stents In OPPS Proposal

The US Medicare agency has been scrutinizing two new devices that have generated some buzz within the industry for pass-through payment status under its proposed 2020 Outpatient Prospective Payment System (OPPS) rules. The devices are Procept BioRobotic’s AquaBeam System for removal of prostate tissue in men with urinary tract symptoms, and Boston Scientific’s Eluvia drug-eluting stent for treatment of peripheral artery disease.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT124812

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