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PLC Medical Systems' Heart Laser receives Investigational Device Exemption (IDE)

This article was originally published in Clinica

Executive Summary

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.





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