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(Nasdaq:RADX), Irvine, Calif., has completed enrollment in the BRITE II (Beta Radiation to Reduce In-Stent Restenosis) pivotal clinical study.
The BRITE II study was designed to support a PMA (Pre-Market Approval) filing with the United States Food and Drug Administration.
The BRITE II is a multi-center, randomized study to determine the safety and effectiveness of the RDX Coronary Radiation Delivery System in patients who have had a coronary stent implanted and have returned to the hospital with in-stent restenosis.