Vancouver’s Kardium has announced the first-in-human study of its next generation Globe® Pulsed Field System to treat atrial fibrillation (AF) using pulsed field ablation (PFA) therapy.
Working with Dr. Vivek Reddy from New York’s Mount Sinai Hospital, and Prof. Petr Neužil and Dr. Jan Petrů from Prague’s Na Homolce Hospital, the Kardium team successfully treated 38 patients, isolating 100% of the patients’ pulmonary veins using the Globe Pulsed Field System.
The Globe Pulsed Field (PF) System features the revolutionary Globe Catheter with 122 gold electrodes, each of which can map the patient’s cardiac anatomy and electrical activity and deliver PFA energy to the heart to treat atrial fibrillation.
The Globe Catheter uses contact sensing to determine which electrodes are in contact with cardiac tissue to help ensure therapy is delivered effectively to the heart.
“PVI with the Globe PF System was very easy. I could quickly position the catheter in each pulmonary vein, ensure that the electrodes were in good contact, and then deliver pulsed field energy to isolate each vein safely and rapidly from one position,” said Dr. Reddy.
“I also really liked the system’s flexibility in more complex cases. I could map the atrium and then deliver additional pulsed field lesions to isolate the posterior wall quickly and then create a mitral isthmus line.”
Kardium now plans to conduct a global pivotal clinical study of the Globe PF System in the US, Canada, Germany, and the Czech Republic for the purpose of obtaining regulatory approval for commercial sales.