Imricor Medical Systems (ASX: IMR) has received Swissmedic approval for the VISABL-AFL clinical trial to commence at the Lausanne University Hospital (CHUV) in Lausanne, Switzerland.
Swissmedic is the Competent Authority in Switzerland, and its approval is the final approval required for CHUV to join the trial. As reported in March, the Ethics Committee at CHUV already approved the study. Installation planning has begun, and cases are expected to commence in the present quarter.
VISABL-AFL is the global clinical trial to support FDA approval of Imricor’s products in the United States.
CHUV is one of the world’s best hospitals according to Newsweek, and the site recently completed the construction of a cardiology-owned dedicated iCMR lab, specifically built for Imricor’s procedures.
Imricor’s Chair and CEO, Steve Wedan, said that with four sites planning to participate in VISABL-AFL, the company expects to complete the trial by year-end 2024.
“This is another major milestone in our execution of VISABL-AFL clinical trial and in the opening of the US market for Imricor. This marks the third site fully approved to commence the trial, and we are nearing the phase where patients are enrolled and treated. We are right on track with our plans and schedules,” he said.
Imricor is a leading developer of innovative MRI-compatible medical devices which can be used to carry out real-time iCMR cardiac ablation procedures.
