Galaxy Medical announced today that it received CE mark approval in Europe for its Centauri pulsed electric field (PEF) system.
San Carlos, California-based Galaxy Medical designed its Centauri system to target arrhythmias by delivering quick bursts of high-voltage, high-frequency energy for the treatment of paroxysmal AFib.
The company said in a news release that 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,” Galaxy Medical CEO Dr. Jonathan Waldstreicher said in the release. “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.”
READ: What is pulsed-field ablation? Here’s what you need to know
Centauri’s features include the Centauri Connect module that 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 system delivers focal catheter energy in a monopolar fashion for more consistent and deeper lesions, while 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 also has three energy settings, giving physicians a choice in dosing level specific to the target tissue.
Dr. Ante Anić, electrophysiology laboratory director at University Clinical Hospital in Split, Croatia, treated patients with Centauri through the IntellaNav StablePoint ablation catheters and the Rhythmia HDx mapping system in the first commercial procedures.
“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,” Anić said. “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.”
Galaxy Medical said it will partner with select European centers in the coming months on the initial launch as demand rises, while the company will then plan for a broader rollout afterward.