PMR Adverse Events, Elusive Efficacy Endpoints Cited In Panel Rejection
This article was originally published in The Gray Sheet
Executive Summary
The reliance on hospitalization for angina as a safety endpoint in the clinical trials of CardioGenesis' Eclipse PMR (percutaneous myocardial revascularization) device masked the rate of significant adverse events related to the procedure, according to FDA's Circulatory System Devices Panel.