Vascular hemostasis devices
This article was originally published in The Gray Sheet
Executive Summary
FDA "Dear Colleague" letter issued Oct. 8 recommends that the devices not be used on patients with "suspected double-wall punctures," and that users "carefully weigh the risk of bleeding at the puncture site" in patients medicated with platelet glycoprotein IIb/IIIa receptor inhibitors. While two adverse events, involving a myocardial infarction and ruptured pseudoaneurysm, are cited as examples by FDA, an increase in overall adverse event rates for the devices has not been observed recently, staffers note. Manufacturers include Datascope (VasoSeal), and Kensey Nash (Angio-Seal)