Pulse Biosciences announced that the FDA granted approval for its Investigational Device Exemption (IDE) for the nPulse Cardiac Catheter Ablation System Study.
The study aims to treat paroxysmal atrial fibrillation (PAF) using nanosecond Pulsed Field Ablation technology.
The IDE approval marks a significant step in evaluating the safety and effectiveness of the nsPFA Cardiac Catheter System.
Primary Safety and Effectiveness Study
The IDE allows Pulse Biosciences to conduct a multicenter study to demonstrate the safety and effectiveness of the nanosecond PFA technology for treating paroxysmal atrial fibrillation.
Novel nPulse Cardiac Catheter Design
The nPulse Cardiac Catheter is designed to deliver complete circumferential lesions in a single application, offering potential advantages over existing systems.
Global Enrollment and Collaboration
The study plans to enroll up to 145 patients across 30 sites, including international sites, to gather comprehensive data on the efficacy of the nsPFA technology.
Potential for Improved Ablation Procedures
The nanosecond PFA platform aims to reduce collateral injury by delivering lower total energy, setting a new standard for atrial fibrillation ablation procedures.
- The FDA IDE approval signifies a major milestone for Pulse Biosciences, paving the way for advanced clinical evaluations of the nsPFA technology.
- The innovative nPulse Cardiac Catheter design and technology have the potential to revolutionize atrial fibrillation treatment by enhancing safety and efficiency in ablation procedures.
The FDA IDE approval for Pulse Biosciences' nPulse Cardiac Catheter Ablation System Study marks a significant advancement in the field of atrial fibrillation treatment, with the potential to improve patient outcomes and simplify clinical procedures.