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Imricor Medical Systems has signed a distribution agreement with Al Faisaliah Medical Systems (FMS), granting FMS exclusive rights to market and sell Imricor's iCMR ablation products in Saudi Arabia, marking Imricor's entrance into the Middle East region.
Saudi Arabia, which conducts nearly 50,000 cardiac ablation procedures annually, will be the first country in the Middle East to offer these products, with the product launch expected to start on October 1st, 2023.
This agreement is a part of Imricor's strategy for expansion and growth in strategic markets, and the company plans to further expand its presence in the Middle East over time.
Imricor Medical Systems, Inc. has received approval from the US FDA for its application for an Investigational Device Exception (IDE) to initiate a clinical trial in the US for “Vision-MR Ablation of Atrial Flutter”.
The clinical trial will include a sample size of 91 patients, with interim analysis after 76 patients have achieved the 7-day follow-up.
Enrolling of patients in the study will begin around mid-year.