FDA Official Scolds Industry For Supporting Off-Label Use Of Biliary Stents
This article was originally published in The Gray Sheet
Executive Summary
FDA is concerned that off-label use of biliary stents to open up clogged leg arteries has gotten out of control, and signaled plans last week to increase oversight of the practice
You may also be interested in...
FDA Rounds Up Biliary Stent Makers On Off-label Promotion
FDA gathered biliary stent manufacturers to discuss how to prevent off-label marketing for peripheral vascular disease while it clarifies the regulatory pathway for vascular stents
FDA Rounds Up Biliary Stent Makers On Off-label Promotion
FDA gathered biliary stent manufacturers to discuss how to prevent off-label marketing for peripheral vascular disease while it clarifies the regulatory pathway for vascular stents
Cook’s Zilver PTX Safety Trial Finds No Stent Fractures
Preliminary results of Cook Medical's safety trial for its Zilver PTX paclitaxel-eluting superficial femoral artery stent showed no stent fractures and a major adverse event rate equal to balloon angioplasty, the firm reports