Galaxy Medical has announced that it received the CE mark for its Centauri pulsed electric field (PEF) system and launched its commercial programme.
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, Galaxy Medical said in a press release.
Centauri has a number of features, including a ‘Centauri Connect’ module allowing 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.
Further to this, Galaxy Medical adds that the focal catheter energy is delivered in a monopolar fashion, creating more consistent and deeper lesions, while its 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 also offers three energy settings, allowing physicians to choose dosing specific to the target tissue.
In the first commercial procedures, Ante Anić (University Clinical Hospital, Split, Croatia) treated patients with Centauri through Intellanav Stablepoint ablation catheters and the Rhythmia HDx mapping system. 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.”
Johan Vijgen (Jessa Hospital, Hasselt, Belgium) assisted Anić. He commented: “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.”