PLC Medical Systems' Heart Laser receives Investigational Device Exemption (IDE)
This article was originally published in Clinica
PLC Medical Systems has been granted an Investigational Device Exemption to conduct a US clinical study using its Heart Laser. The 400-patient, multicentre, randomised, controlled trial will compare transmyocardial revascularisation (TMR) using the Heart Laser with second-time coronary artery bypass graft (CABG) surgery. It will begin as soon as PLC receives institutional review board approval at each clinical site - clearance has so far been given for 10 of the intended 40 sites.