First in Human Ischemic VT Ablation Successfully Performed in iCMR

Imricor Medical Systems, Inc. (Company or Imricor) (ASX: IMR), together with Amsterdam University Medical Centre (Amsterdam UMC), is pleased to announce the successful completion of the first Ischemic Ventricular Tachycardia (VT) ablation ever performed under real-time MRI guidance in an iCMR lab.

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Imricor’s NorthStar® Mapping System

The Amsterdam UMC team, shown here, performed the VT ablation procedure following previous experiences performing atrial flutter and premature ventricular complex (PVC) ablation procedures guided by real-time MRI and Imricor’s NorthStar^® Mapping System.

Regarding the VT procedure, Dr. Kemme, stated: “This procedure is part of an international research programme. The MRI imaging shows us precisely where the myocardial infarction took place; therefore, we can send the catheter to the exact spot. This information can make ablation possibly more effective.”

Background

Ischemic VT is one of the most challenging and life-threatening arrhythmias. Conventional VT ablations can routinely take more than 8 hours and deliver success rates as low as 40 percent. Until now, Imricor technology has been used for atrial flutter and premature ventricular complex (PVC’s) ablations.

Key Clinical World Firsts

The procedure, successfully performed by the outstanding team at Amsterdam UMC, involved several world firsts. Crossing the septum, from the right side of the heart to the left had never been performed in a human under MRI guidance. This is a critical step in moving towards complex ablations for atrial fibrillation (AF) and VT.

Dr. Kemme further noted: “Thanks to the interventional MRI, we can see exactly in 3D where the sheath and ablation catheter are. This allowed us to move from the right atrium to the left atrium through the septum. It gives us much more information than the usual method.”

In another world first, ablation lesions have been delivered from inside the ventricle under real-time MRI guidance. In addition, many VT patients live with an ICD to prevent sudden cardiac death. This procedure demonstrated the ability to safely and effectively treat high risk patients even with an ICD implanted. This has been one of the remaining questions from the field which has been answered via this procedure.

Impact

This milestone marks a watershed moment for the field of MRI-guided electrophysiology. The achievement reflects the culmination of years of collaborative innovation, combining Imricor’s advanced device portfolio with the world-class clinical expertise of the team at Amsterdam University Medical Centre. The successful procedure paves the way for broader clinical use of MRI-guided ablations, with additional sites in Europe expected to join the VISABL-VT trial over the coming months.

Imricor’s Chair and CEO, Steve Wedan, commented: “This is a defining moment for Imricor and for the field of electrophysiology. Performing the world’s first ischemic VT ablation entirely inside the MRI validates our core vision, that real-time MR guidance can unlock safer, more effective, and more personalized treatments for patients with complex arrhythmias.

“The world-class team at the Amsterdam University Medical Centre has made a tremendous leap forward for the world, and I congratulate and thank them for this historic achievement. Together, we are paving the way for a future where MR-guided procedures become the global standard of care.

“I also want to congratulate the extraordinary team at Imricor who accomplished something no one else has ever been able to do, by delivering all the devices, systems, partnerships, collaborations, regulatory processes, and clinical development that make this all possible.

“This milestone settles the science and opens the future. The ability to perform complex ablations entirely inside the MRI is no longer theoretical. It’s real, and it’s just the beginning of a worldwide transformation in how electrophysiology, and other interventions, are performed.”

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