- The disease
- Cardiac arrhythmias such as typical atrial flutter (AFL) and ventricular tachycardia (VT) are abnormal heart rhythms that can cause symptoms ranging from palpitations to life-threatening cardiac events. Catheter ablation is an established treatment in which targeted areas of heart tissue are destroyed to interrupt the abnormal electrical pathways causing the arrhythmia. Conventional ablation procedures are performed under X-ray fluoroscopy guidance, which exposes patients and clinical staff to ionising radiation and provides limited soft-tissue visualisation of the heart.
- What the asset is trying to do
- The Vision-MR Deflectable Sheath is a steerable introducer sheath designed to be used inside a magnetic resonance imaging (MRI) scanner during cardiac ablation procedures. It is built from MRI-compatible materials that do not distort the MRI image or pose heating risks inside the scanner bore. The device is used together with Imricor's Vision-MR Ablation Catheter to allow real-time MRI visualisation of catheter position and cardiac anatomy during radiofrequency (RF) ablation, rather than relying on X-ray fluoroscopy.
- What the trial is measuring, and why it matters
- The active trials measure procedural and clinical outcomes of MRI-guided ablation using Imricor's system. NCT05904548 focuses on typical atrial flutter ablation in an integrated cardiac MRI (iCMR) suite (per ClinicalTrials.gov NCT05904548), while NCT05543798 focuses on VT ablation using the Vision-MR Ablation Catheter 2.0 (per ClinicalTrials.gov NCT05543798). Procedural success, safety events, and acute ablation outcomes are the types of endpoints typically assessed in device-based ablation studies.
- Efficacy benchmarks in this setting
- In conventional X-ray-guided catheter ablation for typical atrial flutter, acute procedural success rates of approximately 95% or above have been reported in published literature; however, the specific figures vary by study population and operator experience, and analysts should consult peer-reviewed sources for the relevant comparator data. For VT ablation, outcomes differ substantially by patient population (ischaemic versus non-ischaemic cardiomyopathy) and prior therapy history, and published benchmarks should be sourced accordingly. The enrolment figures and any interim procedural data from Imricor's active trials (NCT05904548 and NCT05543798) are early-stage observations from non-randomised studies and are not statistically comparable to outcomes from established ablation systems.
- Commercial context
- The Vision-MR system has received CE Mark approval in Europe, permitting commercial use in applicable European markets (per Imricor public disclosures). As of June 2026, Imricor had submitted the third pre-market approval (PMA) module to the US Food and Drug Administration (FDA) for review, indicating the US approval process remains ongoing (per ASX announcement, 10 June 2026). No US FDA approval for this device has been disclosed as at the date of the most recent announcement. The Vision-MR system is described as Imricor's lead commercial asset. No disclosed licensing, partnering deal values, or manufacturing cost figures are available in the provided data.