Leading medical device company Imricor Medical Systems (ASX: IMR) continues to generate clinical data for its groundbreaking MRI-compatible catheter after receiving approval from the Ethics Committee at Lausanne University Hospital to participate in the VISABL-AFL clinical trial.
VISABL-AFL is Imricor’s global clinical trial assessing the safety and efficacy of atrial flutter ablation procedures performed with the company’s Vision-MR Ablation Catheter and HAT 500 RF generator and irrigation pump.
The trial will include sites in the US and Europe and clinical results are expected to support a critical FDA application, paving the way towards commercial sales in the USA.
Approval from the Lausanne University Hospital Ethics Committee is the first of two checkboxes to be ticked for the hospital to join the trial. The second and last approval required is from Swissmedic, the Competent Authority in Switzerland.
Lausanne University Hospital is one of the world’s best hospitals according to Newsweek, and the site recently completed the construction of a cardiology-focussed lab, specifically built for Imricor’s procedures.
The Swiss hospital is one of several prestigious organisations to participate in the trial, with physicians at the globally renowned Johns Hopkins Hospital in the USA enrolling patients suffering from atrial flutter.
Ethics Committee approval processes is also underway at Amsterdam University Medical Center and the Cardiovascular Institute of South Paris.
With four sites planning to participate in VISABL-AFL, Imricor expects to complete the trial by year-end 2024.
“We are one step closer to getting our FDA trial started at the [Lausanne University Hospital]. We expect enrolment of patients to commence shortly after Johns Hopkins begins their enrolment.
“Our clinical team’s plans for executing an efficient multi-centre study for VISABL-AFL is on track, which means our FDA process and US launch are also on track,” Imricor’s Chair and CEO, Steve Wedan, said.
The Vision-MR Ablation Catheter has been approved in the European Union and the Kingdom of Saudi Arabia (KSA) with an indication for treating type 1 atrial flutter.
Imricor is also pursuing the required regulatory approvals for its key products in Australia and other Middle East countries.
