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.
CardioFocus is the exclusive distributor of the CENTAURI System.
Overview
The CENTAURI System for use in conventional intracardiac ablation procedures uses Pulsed Electric Field (PEF) technology that 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
The six-pillar approach to PEF therapy
The six-pillar approach to PEF therapy for use in conventional intracardiac ablation procedures gives electrophysiologists a next generation ablation tool designed for the highest level of safety and efficacy.
Wave 1
The proprietary waveform CardioFocus has customized for use in conventional intracardiac ablation procedures balances full-thickness tissue ablation while limiting the effects on extracardiac structures.
Energy setting
The CENTAURI Constellation energy delivery scheme gives physicians control, allowing one of three doses to be used for varying tissue thickness.
Zero bubbles
The WAVE1 waveform was designed to significantly reduce microbubbles which may embolize to the brain. CENTAURI has been designed using WAVE1 energy for safe and effective delivery of PEF. Our goal is a safe and effective delivery of PEF with zero bubbles.
Monopolar
CENTAURI uses monopolar PEF delivery for lesion control.
Automatic impedance
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.
Current control
The CENTAURI current control algorithm ensures a consistent current output from the catheter in all patients ensuring predictable lesion size.
Clinical studies
Two clinical studies have been conducted to characterize the safety and efficacy of CENTAURI.
Safety outcomes
Esophageal injuries
0%
Phrenic nerve injuries
0%
PV stenosis
0%
Incidence of microbubbles per avaluation on intracardiac echocardiagram during ablation
0%
Overall, 89% PV isolation 3 months using CENTAURI System with three compatible commercially available cardiac ablation catheters
Eclipse-AF PV isolation rate at 3 months
Overall PV Isolation Durablity = 89%
92% PV isolation at 3 months using the CENTAURI System with the Biosense Webster THERMOCOOL SMARTTOUCH™ ablation catheter
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™
Anić A et al. Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results. Europace. 2023 Jun 2;25(6):euad147.