Imricor Medical Systems kicks off VISABL-AFL trial for US FDA approval

Imricor Medical Systems, Inc. (ASX:IMR) has launched its VISABL-AFL global clinical trial last week, for securing the US Food and Drug Administration (FDA) approval, in what is claimed to be a “huge milestone” for the company.

The trial, initiated with two procedures at the Cardiovascular Institute of South Paris (ICPS), aims to evaluate the safety and efficacy of atrial flutter ablation using its Vision-MR Ablation Catheter.

The Vision-MR Ablation Catheter is specifically designed to work under real-time MRI guidance.

It enables higher success rates along with a faster and safer treatment compared to conventional procedures using x-ray-guided catheters.

“We are on track with VISABL-AFL to complete enrolment this year, supporting our goal of FDA approval for our platform of technology in the US in 2025,” said CEO Steve Wedan

Study summary

The trial, named “Vision-MR Ablation of Atrial Flutter” (VISABL-AFL), is a prospective, single-arm, multi-centre study.

It involves the Vision-MR Ablation Catheter (second generation) and Osypka HAT 500 RF generator and irrigation pump.

Notably, the study spans four sites across the United States and Europe, with a sample size of 91 patients.

An interim analysis will be conducted after 76 patients have completed the 7-day follow-up. Full trial enrolment is on track for completion by the end of 2024.

About Imricor

Imricor is a leading developer of innovative MRI-compatible medical devices that can be used to carry out real-time iCMR cardiac ablation procedures.

Its prime offering, 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.

In addition, Imricor intends to seek approval for expanded indications in the future.

Furthermore, the company is also pursuing the required regulatory approvals to place its key products on the market in Australia, the U.S., and the other Middle East countries.

 

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