Torax Medical Receives FDA Approval for its FENIX® Continence Restoration System to Treat Fecal Incontinence

Important Safety Information

Humanitarian Device: Authorized by the Federal (USA) Law for use in the treatment of fecal incontinence in patients who are not candidates for or have previously failed conservative treatment and less invasive therapy options (e.g., injectable bulking agents, radiofrequency ablation, sacral nerve stimulation). The effectiveness of this device for this use has not been demonstrated.

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