Changes to Taxus manufacturing
This article was originally published in The Gray Sheet
Executive Summary
FDA approves special PMA supplement May 5 for Boston Scientific to modify the laser bonding process used to unite the drug-eluting stent's delivery catheter and balloon prior to packaging. The move responds to physician complaints about the balloon not deflating properly or sticking to the stent coating during removal (1"The Gray Sheet" May 3, 2004, In Brief). A recall will not be initiated, the company says, claiming the best way to avoid potential problems with existing stents is to follow the instructions for use, specifically concerning inflation and deflation timing and pressure. Boston Scientific attributes the issues to physicians being unfamiliar with the system. FDA does not plan to formally address the issue; however, the agency notes its will provide communications if further problems arise...