Imricor Medical Systems, Inc. announced that the US Food and Drug Administration (FDA) has approved the Company's application for an Investigational Device Exception (IDE) to initiate a clinical trial in the United States. The Company applied for an IDE to commence the "Vision-MR Ablation of Atrial FLutter" or VISABL-ALF clinical trial. VISABL-AFL is a prospective, single-arm, multi-centre global investigational study of the safety and efficacy of type I atrial flutter ablation procedures performed with the Vision-MR Ablation Catheter (second generation) and Osypka HAT 500 RF generator and irrigation pump.

The study will include sites in the US and Europe, with an enrolment cap of 50% of the total enrolment population coming from outside the US. The sample size is 91 patients, with an interim analysis after 76 patients have achieved the 7-day follow-up. Final follow-up is 3 months.

Institutional review board (IRB) approval is required prior to commencing the trial at each site. The Company expects to begin enrolling patients in study around mid-year.