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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.

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