Request for Service: Pulse Field Ablation Comparative Assessment Development

The FDA is seeking a contractor to collaborate on a project to develop an in vitro test platform for evaluating the hemolytic potential of Pulsed Field Ablation (PFA) devices. The contractor will be responsible for fabricating reusable PFA catheters, developing a robust comparative PFA hemolysis benchtop test platform, and creating a detailed standard operating procedure (SOP) for conducting hemolysis bench tests. The contractor must have demonstrated expertise in PFA research and access to a Biosafety Level 2 (BSL-2) or higher laboratory environment. • The contractor must fabricate a minimum of 30 newly-fabricated pulse field ablation electrodes that meet specific design and material requirements. • The contractor must develop a tissue phantom for characterization of electrical fields when in contact with tissue. • The contractor must conduct static blood testing to investigate the effects of PFA pulse parameters on hemolysis. • The contractor must provide detailed protocols and data for all tests and procedures.