April 21, 2019

FDA Schedules Public Meeting on Paclitaxel Use in PAD

April 22, 2019—The FDA announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee will convene a public meeting to discuss and make recommendations on information related to recent observations of increased long-term mortality in patients with peripheral arterial disease treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared with patients treated with uncoated comparator devices.

The meeting, which will be open to the public, will be held on June 19 from 8:00 AM to 5:00 PM and June 20 from 8:00 AM to 3:00 PM at the Gaithersburg Holiday Inn in Gaithersburg, Maryland.

FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings. The general function of the committee is to provide advice and recommendations to the agency on FDA's regulatory issues.

More information is available online, here. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 22, 2019.

For details regarding these data and all news related to the ongoing controversy regarding paclitaxel use in PAD, please visit our comprehensive continuing coverage page.


April 23, 2019

Surmodics' Sublime Guide Sheath Receives FDA Clearance

April 19, 2019

Multisociety Position Statement Supports PAE to Treat Lower Urinary Tract Symptoms Attributed to BPH