Radiance
This article was originally published in The Gray Sheet
Executive Summary
Irvine, California firm expects to begin enrollment in the U.S. arm of its international RAPID (Radiation After PTA is Done) trial in the third quarter of 2001, following FDA approval of the firm's investigational device exemption, announced Aug. 9. The study, which will include up to 50 patients at six sites, will assess the ability of the RDX radioactive balloon brachytherapy device to treat peripheral vascular disease. Clinical endpoints include target revascularization and six-month clinical follow-up with angiogram. In May, Radiance began enrolling patients in the European arm of the RAPID study (1"The Gray Sheet" July 2, 2001, In Brief)