In Brief: PLC Systems
This article was originally published in The Gray Sheet
Executive Summary
PLC Systems: Anticipates FDA approval in late 1995 or early 1996 for an investigational device exemption application for performing transmyocardial revascularization with its Heart Laser device in conjunction with coronary bypass. The firm recently received permission to expand a study comparing its system to repeat bypass ("The Gray Sheet" Aug. 21, In Brief). PLC also plans an IDE to examine the effect of TMR on heart transplant patients and is investigating whether an additional IDE would be necessary to perform TMR using a thoracoscope. Two thoracoscopic procedures have been completed in Switzerland...