Human Trials Allowed for Radiance System

Radiance Medical Systems Inc. said the Food and Drug Administration gave an exemption that clears the way for the Irvine company to begin human clinical trials in the United States for a device to reduce the recurrence of arterial blockage.

Radiance Medical said the trials will measure its RDX Catheter Radiation Delivery System’s effectiveness in reducing the recurrence of arterial blockage, or restenosis, after interventional treatment for atherosclerotic disease.

The company expects to complete the initial phase of the trials by the end of this year. Radiance Medical said it launched a clinical study of the RDX Catheter System in Europe last year. The European study has 50 participants so far. Radiance Medical makes site-specific delivery catheters for radiation to prevent restenosis.

The company’s shares closed Monday at $8.63, up 50 cents on Nasdaq trading.