CENTAURI™ System

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.

Galvanize’s custom waveform, for use in conventional intracardiac ablation procedures, balances full-thickness tissue ablation while limiting the effects on extracardiac structures.
The CENTAURI Constellation energy delivery scheme gives physicians control, allowing one of three doses to be used for varying tissue thickness.
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.

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.

SAFETY OUTCOMES

Esophageal injuries

Phrenic nerve injuries

PV stenosis

Incidence of microbubbles per evaluation on intracardiac echocardiogram during ablation

0%

0%

0%

0%

SAFETY OUTCOMES

Overall, 89% PV isolation 3 months using CENTAURI System with three compatible commercially available cardiac ablation catheters
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™

ECLIPSE-AF PV ISOLATION RATE AT 3 Months

Overall PV Isolation Durability = 89%

WAVE1 Technology Minimizes Gaseous Microemboli Associated with PEF Energy Delivery

Traditional waveforms produce bubbles on intracardiac echo and carotid doppler versus CENTAURI with no observable bubbles.

Clinical Trials

Atrial Fibrillation

ACTIVE NOT RECRUITING

SPACE-AF

ECLIPSE-AF