Spectranetics panel date set
This article was originally published in The Gray Sheet
Executive Summary
Results from the laser angioplasty to treat critical limb ischmia (LACI) trial, conducted in support of an expanded indication for Spectanetics' CVX-300 excimer laser, will be reviewed by FDA's Circulatory System Devices Advisory Panel Oct. 2. The Colorado Springs, Colo.-based firm expects approval of the PMA supplement by year-end or in early 2004, assuming a favorable panel review for the CLI indication (1"The Gray Sheet" July 21, 2003, p. 14)...