CardioGenesis to begin study of ITMR laser system as adjunct to CABG.
This article was originally published in The Gray Sheet
Executive Summary
CARDIOGENESIS MYOCARDIAL REVASCULARIZATION STUDY PATIENT ENROLLMENT commences under an investigational device exemption recently approved by FDA. The prospective, randomized and blinded study, which will include approximately 500 patients in 25 U.S. centers, will contrast patients treated with CardioGenesis' Intraoperative Transmyocardial Revascularization (ITMR) and coronary artery bypass grafts (CABG) with patients treated with CABG alone. Endpoints for the study will be reduction in chest pain and changes in exercise tolerance via a treadmill test. Regional perfusion and quality of life measures also will be evaluated.