Eclipse's minimally-invasive direct coronary artery bypass (MIDCAB) surgery trial receives investigational new device exemption (IDE):
This article was originally published in Clinica
Eclipse Surgical Technologies has received an IDE from the FDA to begin the first US clinical study of its minimally-invasive approach to transmyocardial revascularisation (TMR). The company's TMR laser will be used in combination with minimally-invasive direct coronary artery bypass surgery (MIDCAB) to treat additional areas of the heart that this surgical technique alone cannot revascularise. MIDCAB uses incisions between the ribs rather than cutting through the sternum. Eclipse, based in Sunnyvale, California, received European approval to affix CE marking to its TMR laser in December.