MEDTRONIC CAPSURE EPI EPICARDIAL STEROID-ELUTING PACING LEAD APPROVABLE WITH CONDITIONS, PANEL FINDS; POSTMARKET STUDY OF 50-60 ADULTS RECOMMENDED
This article was originally published in The Gray Sheet
Executive Summary
Medtronic's CapSure EPI epicardial steroid-eluting pacing lead is approvable with conditions for adult and pediatric patients in whom transvenous leads cannot be used, FDA's Circulatory System Devices Panel concluded at a July 15 meeting in Rockville, Maryland. The panel agreed that the lead (model 4965) can be used for bradycardia pacing in pediatric patients with anatomy too small to accommodate transvenous leads and in adults with conditions that preclude access with a transvenous system.