Under the agreement Galaxy will pursue U.S. regulatory approval for Japan Lifeline’s Alpha1 in support of the commercialization of Galaxy’s Centauri pulsed electric field system, which can be used with the ablation catheter.
Alpha1 is designed to handle increased electrical demands associated with pulsed electric field therapy without having to sacrifice the handling, flexibility or expected feel.
The ablation catheter has an 8 Fr outer diameter, 4 mm platinum ablation tip and a full 180 degrees of bilateral deflection. It works with two features unique to the Centauri PEF system: the Wave1 waveform that reduces muscle stimulation and eliminates microbubbles and the Centauri Connect box that allows physicians to perform PEF ablation procedures with focal catheters and mapping systems in radiofrequency procedures.
“We have long sought to bring our outstanding ablation technologies to the US market. In this partnership with Galaxy and their expertise in PEF technology, we aim to be at the forefront of innovation in ablation, bringing new therapies to the millions of people worldwide who suffer from cardiac arrhythmias,” Japan Lifeline CEO Kei Suzuki said in a news release.
“We are thrilled to partner with Japan Lifeline on the first focal PEF system. Over the last several months, Galaxy and JLL engineers have collaborated to design Alpha1, allowing PEF energy to target a wide array of arrhythmias,” Galaxy Medical CEO Jonathan Waldstreicher said. “We chose to start with a focal approach because 87% of catheter ablations worldwide are performed in this manner, aligning with our mission of democratizing the use of PEF energy. As we embark on clinical trials with the system, we hope to demonstrate enhanced safety and efficacy as compared to today’s standard of care.”