Galaxy Medical today announced that it received the CE Mark for its CENTAURI Pulsed Electric Field (PEF) System and launched its commercial program.
The approval allows the company to market the system for the treatment of paroxysmal atrial fibrillation (AF) in the European Union and geographies that accept the CE Mark. PEF targets arrhythmias by delivering quick bursts of high-voltage, high-frequency energy. CENTAURI is the first commercially available system to enable PEF ablation with focal catheters which are used in the majority of cardiac ablation procedures worldwide.
“From the beginning, we designed CENTAURI to be the workhorse PEF system for all electrophysiology labs, enabling physicians to maintain use of their favored mapping systems and catheters,” commented Jonathan Waldstreicher, MD, CEO of Galaxy Medical. “Our goal is to provide a safer and more effective alternative to thermal ablation for all practitioners of cardiac arrhythmia ablation, and the CE Mark allows us to offer CENTAURI to electrophysiologists broadly.”
CENTAURI has several unique features:
- The CENTAURI Connect module allows physicians to perform PEF ablation procedures with marketed focal catheters and mapping systems without adjustments to workflow or the typical learning curve of training on new catheters.
- The focal catheter energy is delivered in a monopolar fashion, creating more consistent and deeper lesions.
- The proprietary WAVE1 waveform eliminates microbubbles observed with other PEF ablation products that can cause brain lesions and strokes, enabling monopolar energy delivery without significant muscle contraction.
- CENTAURI offers three energy settings, allowing physicians to choose dosing specific to the target tissue.
In the first commercial procedures, Dr. Ante Anić, MD, Electrophysiology Laboratory Director at University Clinical Hospital in Split, Croatia, treated patients with CENTAURI through INTELLANAV STABLEPOINTTM Ablation Catheters and the RHYTHMIA HDxTM Mapping System. Dr. Anic commented: “Having observed the progression of CENTAURI from preclinical studies through the greater than 90% chronic durability for pulmonary vein isolation (PVI) that we achieved in the ECLIPSE-AF study with catheters from all the major manufacturers, the system will be transformational for my daily practice. In just the first few days, we treated de novo atrial fibrillation patients with PVI and recurrence patients with more extensive, beyond PVI lesion sets, demonstrating ultimate flexibility.”
Dr. Johan Vijgen, Head of the Division of Electrophysiology at Jessa Hospital in Hasselt, Belgium assisted Dr. Anic and said: “Since the release of the first single-shot PFA catheter, we have been anticipating CENTAURI’s arrival to enable us to deliver PEF through the systems installed in our lab. With no adjustment to our workflow, combined with the safety and efficacy in the clinical studies, CENTAURI will be a central part of my tool kit going forward.”
With significant demand, Galaxy Medical is partnering with select European centers in the coming months on the initial launch, after which the company plans a broader rollout.