Radiance
This article was originally published in The Gray Sheet
Executive Summary
Irvine, California firm receives a CE Mark for its RDX radioactive balloon brachytherapy device for treatment of de novo and restenotic coronary lesions. The RDX will be marketed to a few key customers, and then, following a formal launch at the Congress of the Society of Cardiology in Stockholm, Sweden Sept. 1-5, 2001, a widespread launch will start this fall. Meanwhile, Radiance expects to complete enrollment in the 480-patient BRITE II pivotal U.S. trial of the RDX by January 2002. Last January, Radiance began BRITE-SVG, a worldwide 50-patient Phase I trial of the RDX in saphenous vein grafts and in May began enrolling patients in RAPID, the European trial of the RDX in peripheral vessels. The company expects an IDE for a U.S. peripheral trial in the next few months