In Brief: PLC Systems
This article was originally published in The Gray Sheet
PLC Systems: Plans first quarter 1996 submission of an investigational device exemption to examine the effect of transmyocardial revascularization (TMR) with its Heart Laser device on heart transplant patients. A second IDE submission to perform TMR using a thoracoscope is planned within the same time frame. The firm is awaiting approval for trials using the device in conjunction with coronary bypass. Current studies are comparing use of the device to repeat bypass. A premarket approval application was submitted in April 1995 for use of the device in treating coronary disease in patients without alternative treatment options...
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