FDA approves bypass graft radiation trials:
This article was originally published in Clinica
Executive Summary
Radiance Medical Systems has gained permission from the US FDA to begin a phase I clinical study of its RDX coronary radiation delivery system as a treatment for de novo lesions and in-stent restenosis in saphenous vein bypass grafts (SVGs). The BRITE-SVG trial is believed to represent the first FDA-approved study of beta radiation in SVGs, which have larger diameters than native coronary vessels, said Jeff Thiel, president and CEO of the Irvine, California company.