Imricor Medical Systems (ASX:IMR) has announced that the Ethics Committee at the Cardiovascular Institute of South Paris (ICPS) has approved the VISABL-AFL clinical trial.
Imricor said the approval is the first of two required for ICPS to join the trial. The second and last approval required is from the French National Agency for Medicines and Health Products (ANSM).
VISABL-AFL is a global clinical trial designed to support US FDA approval of Imricor’s products. The company said ICPS had constructed a new cardiology-owned MRI lab with design input to ensure the lab is appropriately configured for interventions with its products.
Imrior said that on joining the trial, physicians at ICPS will join physicians at Johns Hopkins Hospital and the Lausanne University Hospital in enrolling patients suffering from atrial flutter into VISABLAFL. The Ethics Committee approval process at Amsterdam UMC is also underway.
With four sites planning to participate in VISABL-AFL, the company expects to complete the trial by the end of 2024.
Imricor’s Chair and CEO, Steve Wedan, said, “After last week’s announcement regarding Ethics Committee approval at the CHUV in Lausanne, we are very excited to announce that the Ethics Committee at ICPS has followed so quickly.
“This is another big step forward for VISABL-AFL, and it reinforces the fact that our FDA approval process and ultimate US launch are on schedule.”