Technology & Product Capabilities
Real-time MRI allows clinicians to visualize cardiac anatomy, catheter position, and tissue changes as they occur. Unlike fluoroscopy, MRI provides direct feedback on lesion formation, edema, and proximity to critical structures. This level of visualization helps reduce missed gaps in the ablation line and improve long-term patient outcomes.
Imricor’s system allows physicians to perform cardiac ablations inside the MRI suite using MR-conditional catheters and recording equipment. Instead of relying on X-ray imaging, the procedure is guided entirely by real-time MRI visualization, giving clinicians a clear view of soft tissue, lesion formation, and catheter position as the procedure happens. This eliminates ionizing radiation and enables real-time therapy delivery and confirmation of block before the patient leaves the table.
The Vision-MR Ablation Catheter 2.0 is the first and only commercially available MR-conditional ablation catheter designed for use during real-time MRI scanning. It combines deflection control, optimized tip design, and full MRI compatibility to deliver energy safely within the magnetic field. By working seamlessly with Imricor’s Advantage-MR EP Recorder/Stimulator system and NorthStar Mapping System, it provides a complete solution for real-time MRI-guided cardiac ablations.
Imricor’s technology is designed for compatibility with leading MRI systems including Siemens Healthineers and Philips Healthcare. This ensures hospitals can integrate iCMR capabilities into existing infrastructure with minimal disruption while maintaining compliance with MR-safety and imaging standards.
Safety & MRI Environment
MRI-guided ablation requires adherence to specialized safety standards. The entire team follows MR-safety protocols governing equipment, patient preparation, and emergency procedures. MR compatible devices and accessories are permitted in the room, and staff complete training for working within the magnetic field. Imricor supports hospitals with detailed implementation guides, readiness assessments, and on-site training to ensure safety and compliance from the first case onward.
MRI-guided ablation eliminates radiation exposure for clinicians and patients because magnetic resonance imaging (MRI) does not use ionizing radiation. As a result, during MRI-guided ablation procedures neither clinicians nor patients are exposed to harmful radiation. Physicians and staff no longer need to wear heavy lead aprons, reducing orthopedic strain and long-term health risks.
An iCMR suite requires MRI-compliant infrastructure such as RF shielding, waveguides for signal cabling, proper HVAC and cooling systems, and MR-conditional monitoring equipment. The control room is typically adjacent to the scanner room for optimal workflow and visibility. Imricor provides site-planning templates and engineering support to help hospitals adapt existing MRI rooms or build new interventional suites.
Clinical Evidence & Outcomes
Clinical experience in Europe results show high procedural success rates with no MRI-related complications. Information on lesion formation is obtained by using special MRI sequences during the procedure that produce immediate information on missed gaps in the lesion, which can translate to fewer repeat procedures and faster recovery times. As adoption grows, ongoing data collection continues to confirm the safety and long-term benefits of MRI-guided ablation.
Multiple clinical studies and ongoing trials demonstrate that MRI-guided ablation provides excellent visibility, strong procedural safety, and the potential to reduce repeat procedures. By enabling direct lesion assessment and eliminating radiation, iCMR represents a next-generation approach to electrophysiology. Programs such as the VISABL-AFL and VISABL-VT trials continue to expand the evidence base for broader indications.
See the following studies:
- Clinical workflow and applicability of electrophysiological cardiovascular magnetic resonance-guided radiofrequency ablation of isthmus-dependent atrial flutter
- Safety, Efficacy, and 2-Year Outcomes of Cardiovascular Magnetic Resonance-Guided Ablation of Isthmus-Dependent Atrial Flutter
- Magnetic resonance imaging–guided conventional catheter ablation of isthmus-dependent atrial flutter using active catheter imaging
Workflow, Training & Staffing
Imricor supports each site with structured onboarding, proctoring, and continuing education. Training covers MR-safety, equipment operation, and procedural workflow inside the magnet. Dedicated Centers of Excellence offer observation and mentorship opportunities.
Procedures follow the similar clinical steps as standard ablation—vascular access, mapping, and energy delivery—but are guided by real-time MRI rather than X-ray. The patient remains in the MRI bore throughout, while clinicians view the catheter tip and tissue response on MR images. This setup allows physicians to verify lesion formation during the procedure, potentially shortening total treatment time and reducing repeat procedures.
Implementation, Economics & ROI
Building an interventional cardiac MRI (iCMR) program involves both facility upgrades and specialized equipment investments. Hospitals typically budget for MRI room modifications—such as RF shielding, waveguides, and ergonomic control layouts—along with Imricor’s MR-conditional EP systems and catheters. Operational costs include disposable devices, staff training, and service agreements for the capital equipment.
Hospitals measure ROI by combining several factors: decreased repeat procedures, lower occupational-health costs, improved staff retention, and the ability to attract new referral streams with an advanced, radiation-free facility. MRI guidance also streamlines decision-making during procedures, which can reduce case times and increase lab throughput. Over time, these gains can make iCMR programs cost-competitive with conventional EP labs while producing safe and effective clinical outcomes.
Regulatory & Market Access
Imricor’s Vision-MR Ablation Catheter 2.0, Vision-MR Diagnostic Catheter, Vision-MR Dispersive Electrode, Advantage-MR EP Recorder/Stimulator System, and NorthStar Mapping System hold CE Mark approval for use in Europe. The ablation catheter is indicated for the treatment of typical atrial flutter. The company’s first generation products are cleared for clinical use in the Kingdom of Saudi Arabia. In the United States, Imricor’s ongoing VISABL-AFL IDE study supports future FDA premarket approval for the Vision-MR Ablation Catheter 2.0.
CE Mark:
- Advantage-MR EP Recorder/Stimulator received CE Mark in 2016
- Vision-MR Ablation Catheter (Type I Atrial Flutter indication) and Vision-MR Dispersive Electrode approved in January 2020.
- Vision-MR Diagnostic Catheter received CE Mark in 2023.
- Vision-MR Ablation Catheter 2.0 (Type I Atrial Flutter indication) received CE Mark in 2024.
- NorthStar Mapping System received CE Mark in 2025.
Other markets:
- Saudi FDA approval for capital equipment and consumables noted in 2024.
United States:
- VISABL-AFL IDE trial underway; first iCMR-guided ablation performed at Johns Hopkins (Aug 2024) to support the Vision-MR Ablation Catheter 2.0 Type I Atrial Flutter indication. (FDA premarket approval pending.)
Expanding Indications:
- VISABL-VT clinical trial commenced (April 2025) at Amsterdam University Medical Centre.