In Brief: Spectranetics
This article was originally published in The Gray Sheet
Executive Summary
Spectranetics: Commences U.S. clinical trials the week of Nov. 6 of a "laser assisted pacemaker lead removal device." The firm says its "laser sheath" device is intended "to thread over an implanted pacing lead and ablate through scar tissue" to aid in the extraction of leads that have been implanted for at least one year. Trials for the device, which received investigational device exemption approval Oct. 19, will involve 318 patients at up to eight clinical sites. Spectranetics expects to complete enrollment by mid-1996...