Kardium has announced the completion of successful first-in-human (FIH) procedures with the Globe pulsed field system.
Vivek Reddy of Mount Sinai Hospital (New York, USA) and Petr Neužil of Na Homolce Hospital (Prague, Czech Republic), performed the procedures in Prague, joined by Jacob Koruth of Mount Sinai Hospital.
Pulsed field ablation (PFA) is an innovative therapy that uses electric fields to treat heart tissue. PFA delivered by the Globe PF System is unique in that it achieves true single-shot isolation; a single application of the GlobePulse Waveform achieves pulmonary vein isolation (PVI) in as little as three seconds, Kardium said in a press release.
“The Globe PF System is an exciting development in the treatment of atrial fibrillation (AF),” said Reddy. “The unique design of the spherical Globe Catheter array, combined with the GlobePulse Waveform, allowed us to isolate the pulmonary veins in just three seconds per vein. We also observed that the PFA treatment was well-tolerated by the patients.”
“The Globe PF System is unique in that it combines mapping and ablation into a single catheter,” said Koruth. “We could navigate the Globe Catheter to the pulmonary veins, confirm contact with the tissue, and be confident that the therapy would be delivered where needed. After ablation, we could confirm isolation through detailed voltage maps and electrograms.”
“The Globe PF System represents a paradigm shift in pulsed field ablation,” said Kevin Chaplin, CEO, Kardium. “These procedures are an exciting step forward for Kardium. Now we prepare to start our US investigational device exemption (IDE) study with the Globe PF System next year.”