Galaxy Medical Obtains CE Marking for its Pulsed Electric Field System

Galaxy Medical today announced that it has received CE Mark approval in Europe for its Centauri Pulsed Electric Field (PEF) System.

Galaxy Medical, based in San Carlos, Calif., designed its Centauri System to target arrhythmias by delivering rapid bursts of high-voltage, high-frequency energy for the treatment of paroxysmal atrial fibrillation.

The company said in a press release that Centauri is the first commercially available system enabling 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 go-to PEF system for all electrophysiology labs, allowing physicians to continue using their favorite mapping systems and catheters,” said Galaxy Medical CEO , the doctor. Jonathan Waldstreicher said in version. “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 at large.”

READ: What is pulsed field ablation? Here’s what you need to know

Centauri features include the Centauri Connect module which enables physicians to perform PEF ablation procedures with commercially available 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 exclusive Wave1 waveform eliminates microbubbles seen with other PEF ablation products that can cause brain damage and strokes, allowing monopolar energy delivery without significant muscle contraction. Centauri also has three energy settings, allowing physicians to choose the target tissue-specific dosage level.

Dr. Ante Anić, director of the electrophysiology laboratory at the University Clinical Hospital in Split, Croatia has treated Centauri patients with IntellaNav StablePoint ablation catheters and the Rhythmia HDx mapping system in the first commercial procedures.

“Having observed the progression of Centauri from preclinical studies to chronic durability greater than 90% for pulmonary vein isolation (PVI) that we achieved in the Eclipse-AF study with catheters of all leading manufacturers, the system will be transformational for my daily practice,” Anić said. “In the first few days alone, we treated de novo atrial fibrillation patients with PVI and relapsed patients with sets of more extensive, beyond the PVI, demonstrating ultimate flexibility.”

Galaxy Medical said it will partner with select European centers in the coming months during the initial launch as demand increases, while the company will then plan for a wider rollout thereafter.