The CENTAURI System has CE certification.
The CENTAURI system in an Investigational device in the United States. Limited by Federal (or United States) law to investigational use.
The CENTAURI™ System for use in conventional intracardiac ablation procedures uses the core Aliya PEF technology but is optimized for cardiac tissue. It connects to marketed mapping systems and focal ablation catheters, enabling PEF to be delivered through the tools electrophysiologists already have in their labs.
As compared to thermal (hot or cold) technologies, PEF ablation may have significant safety advantages including reductions in:
- Esophageal injury
- Phrenic nerve injury
- Pulmonary vein stenosis
- Stroke induced by microbubble formation from ablation
Galvanize Electrophysiology’s six-pillar approach to PEF therapy for the use in conventional intracardiac ablation procedures gives electrophysiologists a next generation ablation tool designed for the highest level of safety and efficacy.
CENTAURI uses monopolar PEF delivery for lesion control.
Tissue impedance is patient specific and impacts lesion formation during PEF delivery. CENTAURI monitors this between every delivery and optimizes dosing parameters to ensure consistent predictable transmural lesions.
The CENTAURI current control algorithm ensures a consistent current output from the catheter in all patients ensuring predictable lesion size.
Galvanize has conducted two clinical studies to characterize the safety and efficacy of CENTAURI.
Phrenic nerve injuries
90% PV isolation at 3 months using the CENTAURI System with the Boston Scientific INTELLANAV STABLEPOINT™ ablation catheter
84% PV isolation at 3 months using the CENTAURI System with the Abbott TactiCath™ Contact Force Sensing Catheter, Sensor Enabled™
ECLIPSE-AF PV ISOLATION RATE AT 3 Months
Overall PV Isolation Durability = 89%
WAVE1 Technology Minimizes Gaseous Microemboli Associated with PEF Energy Delivery