- Imricor Medical Systems (IMR) receives Investigational Device Exception (IDE) approval from the US FDA to begin its planned VISABL-ALF clinical trial
- Imricor Chair and CEO Steve Wedan says this is a “huge milestone” for the company
- The trial will involve 91 patients at sites in the US and Europe, with a 50 per cent cap in place for individuals from outside the US
- The company aims to start enrolling patients around mid-year
- Shares in Imricor closed grey at 2.7 cents on Tuesday afternoon.
Imricor Medical Systems (IMR) has been granted Investigational Device Exception (IDE) approval from the US Food and Drug Administration (FDA) to begin a clinical trial in the United States.
The company can now focus on its planned “Vision-MR Ablation of Atrial Flutter”, or VISABL-ALF, clinical trial.
VISABL-ALF is an investigational study of the safety and efficacy of type-one atrial flutter ablation procedures performed with the second-generation Vision-MR ablation catheter and Ospyka HAT 500 RF generator and irrigation pump.
Essentially, atrial flutter ablation is a procedure under which scar tissue is created in the upper chamber of the heart to block electrical signals that cause a fluttering heartbeat.
Imricor said catheter sales in the US for cardiac ablation procedures are expected to exceed US$3.8 billion (A$5.4 billion) in 2023.
Imricor Chair and CEO Steve Wedan said receiving approval for its trial was a “huge milestone” for the company.
“We are very pleased to have IDE approval from the FDA,” he said.
“This is a huge milestone for Imricor, moving us one step closer to offering iCMRguided ablation procedures to patients in the US.”
The study will incorporate 91 patients at sites in the US and Europe, with an enrolment cap of 50 per cent of the total enrolment population coming from outside the US.
An interim analysis will be carried out after 76 patients have achieved a seven-day follow-up. The final follow-up is scheduled for three months.
Imricor still requires institutional review board (IRB) approval before commencing the trial at each site.
The company aims to start enrolling patients in the study around mid-year.
Shares in Imricor closed grey at 2.7 cents on Tuesday afternoon.