In Brief: Spectranetics
This article was originally published in The Gray Sheet
Executive Summary
Spectranetics: Premarket approval application for the firm's model 500-001 fiberoptic Laser Sheath will undergo expedited review at FDA, the Colorado Springs firm says in a Jan. 2 release. The device is intended for use with Spectranetics' CVS-300 excimer laser unit to remove pacemaker and implantable cardioverter defibrillator leads by ablating through scar tissue with fiberoptic laser energy. Data supporting the application comes from an ongoing 20-site trial of about 300 patients. Spectranetics announced submission of the PMA in early December ("The Gray Sheet" Dec. 9, In Brief)...