Interventional cardiology firm Radiance Medical Systems has applied to the U.S. Food and Drug Administration to begin phase II of its BRITE clinical study testing its RDX coronary radiation delivery catheter system. The BRITE (Beta Radiation to Reduce In-Stent Restenosis) study will evaluate RDX in a randomized study at approximately 40 clinical centers in the U.S.
Investigators will assess the safety and effectiveness of the RDX system in patients who have had a coronary stent implanted, and have returned to the hospital with restenosis within the coronary artery at site of stent implantation, according to the Irvine, CA-based vendor.
By AuntMinnie.com staff writersSeptember 12, 2000
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Radiance begins CE Mark process for RDX, September 6, 2000
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