Kardium Reports Preliminary PULSAR IDE Trial Data of Globe PF System for Paroxysmal Atrial Fibrillation (PAF)
Shots:
- Kardium has reported 1yr. global PULSAR IDE trial data assessing Globe PF System in 183 symptomatic PAF pts across 12 centers in the US, EU, & Canada; Globe PF under the PMA review with the US FDA
- Trial showed 0% device-related safety events, 78% 12mos. effectiveness, 100% acute procedural success, 25min. average time to isolate all pulmonary veins, & 1.2 PFA applications per vein on average; data was presented at HRS 2025 & full data to be published in future
- Globe PF System integrates single-shot pulmonary vein isolation, advanced mapping, & atrial ablation into 1 catheter
Ref: BusinessWire | Image: Kardium
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