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PLSE Wins FDA IDE Approval to Launch nPulse AF Ablation Study Trial
ZACKS· 2025-12-19 16:25
Key Takeaways PLSE won FDA IDE approval to begin a U.S. multicenter trial of its nPulse system for paroxysmal AFib.The NANOPULSE-AF study will enroll up to 145 patients across 30 sites to assess safety and effectiveness.PLSE's nsPFA technology uses lower energy and single-shot lesions to simplify workflows.Pulse Biosciences (PLSE) recently announced that the FDA has granted Investigational Device Exemption (“IDE”) approval to initiate its nPulse Cardiac Catheter Ablation System study for the treatment of pa ...