Pulsed Field Ablation (PFA) System for Non-Clinical Research Use

The U.S. Food and Drug Administration is seeking a vendor to provide a complete, off-the-shelf Pulsed Field Ablation (PFA) system for non-clinical research use. The system must include a PFA generator, compatible catheters, accessories, and cables, as well as on-site installation, training, and technical support. The proposed system must be FDA-approved or cleared for clinical use in the United States for the treatment of atrial fibrillation or other cardiac arrhythmias. Key features of the system include: • A bipolar, biphasic pulsed electric field waveform suitable for cardiac ablation research • Compatibility with standard building main power • Five unused clinical PFA catheters • Accessories and cables necessary for operation in a non-clinical research environment • Documentation, training, and technical support The vendor must provide a complete and fully functional system that conforms to all requirements of the resulting contract.