Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

Shots:

• The US FDA has granted IDE approval to initiate the NANOPULSE-AF study of Pulse’s nsPFA Cardiac Catheter System for the treatment of PAF
• The study will assess the primary safety and efficacy of the nsPFA Cardiac Catheter System in ~145 pts for the treatment of drug-resistant symptomatic PAF across 30 sites, incl. 3 outside the US
• The nPulse Cardiac Catheter delivers a full circumferential lesion in a single energy application without repositioning, plus it is being evaluated in the 150-patient EU feasibility study, with subject follow-up ongoing

Ref: PR newswire| Image: Pulse Biosciences | Press Release

Related News: Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

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