'Workhorse PEF System' Scores CE Mark

Galaxy Medical has received a CE mark for its Centauri Pulsed Electric Field (PEF) System and launched its commercial program.

The approval allows the San Carlos, CA-based company to market the new pulsed electric field 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 pulsed electric field ablation with focal catheters which are used in the majority of cardiac ablation procedures worldwide, Galaxy Medical said.

"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," said 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."

The company touted the following features of the Centauri saystem:

Ante Anić, MD, electrophysiology laboratory director at University Clinical Hospital in Split, Coatia, performed the first commercial procedures with Centauri through Intellanav Stablepoint ablation catheters and the Rhythmia HDx mapping system.

"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."

Johan Vijgen, head of the electrophysiology division at Jessa Hospital in Hasselt, Belgium, assisted Anić.

"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," Vijgen said. "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 said it is partnering with select European centers in the coming months on the initial launch, after which the company plans a broader rollout.