Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device – the Globe ® PF System
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Kardium Inc., a private medical device company that's advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device—the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in San Diego 1, highlighting the safety and efficacy data of the Globe PF System, which is currently under PMA review with the US FDA.
Key results included:
0% device-related primary safety events
78% 12-month primary effectiveness
100% acute procedural success
25-minute average time to isolate all pulmonary veins
1.2 PFA applications per vein on average
"These impressive one‑year efficacy results underscore the advanced catheter design of the Globe PF System,' said Dr. Vivek Reddy, Co-Principal Investigator from The Mount Sinai Fuster Heart Hospital, New York. 'Given the excellent durability achieved by the Globe PF System, the efficacy result is likely approaching the limit of what we can achieve with PV isolation alone.'
With just 1.2 applications per vein, the Globe PF System is the true single-shot PFA solution with integrated mapping and ablation built into a single catheter.
'We are very pleased with the study's safety results,' says Dr. Atul Verma, Co-Principal Investigator from McGill University Health Centre in Montreal. 'The Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualized patient‑centered treatment decisions."
The PULSAR IDE study is a global, prospective, multicenter, single-arm study to demonstrate the safety and long-term efficacy of the Globe PF System. The study enrolled 183 patients across 12 centers in the United States, Europe, and Canada with symptomatic paroxysmal atrial fibrillation. The data presented at HRS was preliminary and the full data will be included in a publication.
'These are truly outstanding results from the PULSAR IDE study,' said Kevin Chaplin, CEO of Kardium. 'The Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.'
About the Globe PF System
Atrial fibrillation is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide. 2 Unlike other catheter ablation systems, the Globe PF System is the only solution of its kind to combine single-shot PV isolation, advanced mapping and atrial ablation into a single catheter.
About Kardium
We are a rapidly growing, privately held medical solutions company made up of a team of scientists, engineers, creatives and business professionals. Our mission is to deliver the best treatment for atrial fibrillation.
CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements.
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