FDA Clears ESC Medical's GyneLase for Trials
YOKNEAM, Israel, Aug. 15 -- ESC Medical Systems Ltd. has won approval from the US Food and Drug Administration to test its GyneLase diode laser system for the treatment of extreme menstrual bleeding (menorrhagia). The company intends to begin clinical Phase III trials during the fourth quarter and market GyneLase in about 18 months, pending final FDA approval.
GyneLase is a second-generation global endometrial ablation light-based system that uses a procedure known as Endometrial Laser Intrauterine Thermal Therapy (ELITT). The system comprises a small portable tabletop laser and disposable applicator.
The system has already won approval in Europe and other markets. Initial US approval was based on a multi-center study of 195 patients outside the US led by Prof. J. Donnez from Belgium. The data showed a 95 percent success rate, and that the ELITT procedure is three times more likely to stop excessive menstrual bleeding compared with other global endometrial ablation systems, the company said.
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