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Imricor Begins VISABL-AFL Trial for FDA Approval at Cardiovascular Institute of South Paris

Wednesday, June 26, 2024

Imricor Medical Systems, the global leader in real-time iCMR cardiac ablation products, has announced the initiation of the Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter IDE clinical trial. The first procedures were conducted at the Cardiovascular Institute of South Paris (ICPS) (https://icps.fr).

The Electrophysiologist at ICPS and Principal Investigator for the site, stated, "Starting the VISABL-AFL clinical trial is a significant advancement for 3D real-time MRI ablations in the iCMR lab.

The use of Imricor’s NorthStar 3D Mapping System is transformative for this field. We look forward to our continued partnership with Imricor."

The VISABL-AFL (NCT05904548) clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial.

Its main goals are to assess the safety and effectiveness of radiofrequency (RF) ablation of type-I atrial flutter with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.

The study aims to enroll 91 patients, with an interim analysis after 76 patients have completed the 7-day follow-up. It includes four hospitals in the U.S. and Europe.

"The initial RF flutter ablations with the Imricor system were smooth. We are very excited about this development!"

The VISABL-AFL trial uses Imricor’s proprietary NorthStar Mapping System, which enables control of the MRI scanner, real-time MR imaging, 3D image display, active tracking of Imricor devices, and the creation of 3D electroanatomical maps with intracardiac electrogram signals from Imricor’s Advantage-MR system.

"This milestone was achieved thanks to the collaboration of the ICPS team, whose support is vital to the trial's success. It is an honor to work with such a distinguished hospital and the dedicated Imricor team, as we strive to improve patient outcomes and enhance care quality."







Source: businesswire.com

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