Imricor Medical Systems, Inc. (ASX: $IMR) has successfully treated the first patient in the United States as part of the VISABL-AFL clinical trial. The procedure, which took place at Johns Hopkins Hospital in Baltimore, marks a significant milestone in the company's efforts to support US FDA approval for its iCMR-guided ablation platform.
We have been fortunate to work with some of the highest calibre doctors and medical teams across Europe, and to have such an esteemed institution like Johns Hopkins be the first US hospital to use the technology is a real privilege. We are on track to complete enrolment in VISABL-AFL this calendar year, and we hope to have FDA approval mid-2025, thereby making real-time iCMR ablations available to patients and physicians throughout the United States.
Imricor's successful treatment of the first patient in the United States as part of the VISABL-AFL clinical trial marks a significant step towards obtaining US FDA approval for its iCMR-guided ablation platform. The company aims to complete all required procedures by year end and anticipates FDA approval by mid-2025, which would enable the availability of real-time iCMR ablations to patients and physicians across the United States. Imricor's vision to make a meaningful impact on patients, healthcare professionals, and healthcare facilities worldwide is further supported by its ongoing efforts to increase the success rates and reduce the overall costs of cardiac ablation procedures.