PLC Systems
This article was originally published in The Gray Sheet
Executive Summary
Submits investigational device exemption on Nov. 7 for multi- center randomized clinical study of its Heart Laser for transmyocardial revascularization (TMR). The 400-patient trial would compare TMR to "second coronary artery bypass surgery" on the basis of exercise tolerance, myocardial perfusion and angina class, and other quality of life indicators. TMR involves creating small channels in the heart muscle to "provide oxygenated blood a direct conduit to the oxygen-starved tissue," the firm says. PLC hopes to submit a pre-market approval application in 1995 for the device based on studies published earlier this year with patients who were not candidates for bypass or angioplasty ("The Gray Sheet" July 11, p. 14)