Interventional cardiology firm Radiance Medical Systems has applied for a CE Mark to sell and distribute its RDX coronary radiation catheter delivery system in Europe. During the past year, Radiance has been conducting the BETTER (Beta Radiation Trial to Eliminate Restenosis) clinical study to gather clinical data for European authorities, according to the Irvine, CA-based firm.
While the BETTER study continues to enroll patients, the company believes it has accumulated sufficient data to initiate the CE Mark approval process. Following approval, Radiance may begin marketing activities in many non-European countries as well, Radiance said.
The firm expects the approval process to be completed by the end of the first quarter of 2001, and hopes to begin distribution in Europe and beyond in mid-2001.
By AuntMinnie.com staff writersSeptember 6, 2000
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