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CryoCath Technologies

This article was originally published in The Gray Sheet

Executive Summary

Expects to submit an investigational device exemption to FDA next month to commence U.S. clinical trials for the Freezor focal ablation catheter system for supraventricular tachycardia treatment, the company says. The study will enroll "at least 200" patients at between six and eight sites in the U.S. and up to 30 patients in Canada. The firm anticipates filing a premarket approval application with FDA
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