Imricor Performs First Real-Time MRI-Guided Pulsed Field Ablation Using Vision-MR Catheter

Imricor Medical Systems has completed the world’s first Pulsed Field Ablation procedure under real-time MRI guidance, marking a breakthrough in cardiac ablation technology. This pre-clinical success validates their Vision-MR platform’s adaptability and sets the stage for safer, radiation-free heart treatments.

  • First-ever in vivo Pulsed Field Ablation (PFA) performed under real-time MRI guidance
  • Procedure conducted using second-generation Vision-MR Ablation Catheter in iCMR lab
  • PFA offers potential safety and efficiency advantages over conventional radiofrequency ablation
  • Imricor’s technology eliminates ionising radiation exposure during cardiac ablation
  • Company advancing regulatory approvals and market expansion for MRI-compatible products
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A New Frontier in Cardiac Ablation

Imricor Medical Systems, a pioneer in MRI-compatible cardiac ablation technology, has announced a landmark achievement, the world’s first Pulsed Field Ablation (PFA) performed under real-time magnetic resonance imaging (MRI) guidance. Conducted in a pre-clinical setting at their iCMR Design Centre, this procedure represents a significant step forward in the treatment of atrial fibrillation (AF), a common and challenging heart rhythm disorder.

PFA is an emerging energy source for cardiac ablation that promises improved safety and procedural efficiency compared to traditional radiofrequency (RF) ablation. While clinical data have yet to confirm superior efficacy, PFA’s ability to selectively target cardiac tissue with minimal collateral damage is generating considerable interest in the electrophysiology community.

Real-Time MRI, A Game Changer

Imricor’s proprietary technology integrates PFA energy delivery with real-time MRI visualization, allowing physicians to see cardiac tissue in exquisite detail during the procedure. This eliminates the need for x-ray fluoroscopy, thereby removing patient and staff exposure to ionising radiation. The Vision-MR Ablation Catheter, used in this milestone procedure, is designed specifically for MRI-guided interventions, enabling precise planning, execution, and validation of ablations while the patient remains on the table.

Given that atrial fibrillation ablations account for roughly two-thirds of all cardiac ablation procedures worldwide, the potential market impact is substantial. Industry estimates suggest PFA could capture up to 60% of this segment in the future, positioning Imricor’s platform as a versatile solution adaptable to evolving clinical preferences.

Strategic Implications and Next Steps

Steve Wedan, Imricor’s Chair and CEO, highlighted the significance of this achievement as a validation of the company’s long-term vision to perform all electrophysiology procedures under MRI guidance. The successful integration of PFA energy with their Vision-MR platform underscores Imricor’s commitment to innovation and adaptability in a competitive market.

While this milestone was achieved in a pre-clinical animal study, the company is actively pursuing regulatory approvals in key markets including the European Union, the United States, and the Middle East. Imricor’s collaboration with major MRI equipment vendors such as Philips, Siemens, and GE Healthcare further supports the expansion of interventional cardiac MRI (iCMR) labs globally.

Looking ahead, clinical trial results and regulatory clearances will be critical to translating this technological breakthrough into commercial success. The ability to offer safer, more effective, and radiation-free cardiac ablation procedures could redefine standards of care and open new growth avenues for Imricor.

Bottom Line?

Imricor’s pioneering MRI-guided PFA sets a new benchmark, but clinical validation and regulatory wins will determine its market impact.

Questions in the middle?

  • When will Imricor initiate clinical trials to confirm safety and efficacy in humans?
  • How quickly can regulatory approvals be secured in major markets like the US and EU?
  • What partnerships or commercial strategies will Imricor pursue to accelerate iCMR lab adoption?