Imricor Medical Kicks Off VISABL-AFL Trial in Paris

Imricor Medical Systems Inc.’s Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter (VISABL-AFL) IDE clinical trial has begun in France, as doctors have performed the first two procedures at the Cardiovascular Institute of South Paris (ICPS).

“Enrolling the first patients in the VISABL-AFL clinical trial represents a significant step forward for the future of 3D real-time MRI ablations in the iCMR lab,” said Dr. Laurent Fiorina, an operating electrophysiologist at ICPS and the site’s principal investigator.  “Performing procedures with Imricor’s NorthStar 3D Mapping System is a game-changer for this field, and it will have a transformative impact. I look forward to the continued partnership with Imricor.”

The VISABL-AFL clinical study is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with Imricor Medical’s Vision-MR Ablation Catheter 2.0 in the iCMR environment. The sample size is 91 patients, with an interim analysis after 76 patients have achieved the seven-day follow-up. The study includes four hospitals in the United States and Europe.

“We did the first two cases of RF flutter ablations with the Imricor system, and it went quite smoothly. We are very enthusiastic about it!” declare Professor Dr. Jerome Garot, head of Cardiovascular Magnetic Resonance.

Included in the VISABL-AFL trial is Imricor’s proprietary NorthStar Mapping System. NorthStar allows the user to control the MRI scanner, receive magnetic resonance (MR) images in real-time from the scanner, display those MR images in 3D, actively track Imricor trackable devices, and create 3D electroanatomical maps that include intracardiac electrogram signals from Imricor’s Advantage-MR system. The Vision-MR Ablation Catheter is the company’s prime product offering, specifically designed to work under real-time MRI guidance, with the intent of enabling higher success rates along with a faster and safer treatment compared to conventional procedures using X-ray guided catheters. The Vision-MR Ablation Catheter has been approved in the European Union with an indication for treating type 1 atrial flutter. Imricor intends to seek approval for expanded indications in the future. The company is also in the early stages of pursuing the required regulatory approvals to place its key products on the market in Australia and the United States.

Imricor Medical has also obtained EU approval for the Advantage-MR EP Recorder/Stimulator System and its consumable product, the Vision-MR Dispersive Electrode.

Imricor Medical Systems develops MRI-compatible medical devices that can be used to carry out MRI-guided cardiac catheter ablation procedures. Headquartered in Burnsville, Minn., Imricor sells its capital and consumable products to hospitals and clinics for use in interventional cardiac magnetic resonance imaging (iCMR) labs, in which ablation procedures using the Vision-MR Ablation Catheter can be performed. An iCMR lab is an interventional lab that is fitted with MRI equipment for use in cardiac diagnostic and interventional procedures. The installation of iCMR labs is driven primarily by MRI equipment vendors working collaboratively with Imricor. Vendors such as Koninklijke Philips N.V. and Siemens Healthcare GmbH help to targetcertain sites and support the design and construction of iCMR labs for those sites.