Galaxy Medical (Galaxy) and Japan Lifeline (JLL) have announced an exclusive distribution agreement for the ALPHA1 ablation catheter in the USA, developed by Japan Lifeline for use with the Galaxy Centauri pulsed electric field (PEF) system. Under the terms of the agreement, Galaxy will pursue US regulatory approval for ALPHA1 in support of eventual commercialisation of the Centauri PEF system.
ALPHA1 has an 8 French outer diameter, 4mm platinum ablation tip and a full 180 degrees of bilateral deflection. It was optimised to work with the two features within the Centauri PEF system, namely the proprietary WAVE1 waveform, intended to reduce muscle stimulation and eliminate microbubbles seen with other PEF ablation systems; and the proprietary Centauri Connect box allowing physicians to perform PEF ablation procedures with focal catheters and mapping systems used for routine 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,” said Kei Suzuki, CEO of Japan Lifeline.
“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,” said Jonathan Waldstreicher, CEO of Galaxy Medical. “We chose to start with a focal approach because 87% of catheter ablations worldwide are performed in this manner, aligning with our mission of democratising 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.”
Centauri and ALPHA1 are investigational devices and not commercially available.