Skip to main content
  • Excimer Laser-Induced Adverse Coronary Events: Discerning the Merits and Shortcomings of the MAUDE Database Report

    A recent interesting communication from the Cleveland Clinic by Bansal et al.  reported post-marketing surveillance on excimer laser coronary atherectomy (ELCA)-induced adverse events. The data were filed in the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. The importance of such reports to the field of interventional cardiology is highly recognized: continuous verification of patient and device safety; detection and description of device-induced adverse effects; analysis of complications, all of which can serve as a sound source for technical modifications by the industry and improved guidelines for operators. While the MAUDE report by Bansal and colleagues  covers some aspects of these tasks, it also calls for an appraisal.

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details