Bioptimal Bipolar Pacing Catheter

The Bioptimal Bipolar Pacing Catheter is a temporary, transvenous cardiac pacing catheter used for right ventricular pacing. It is made of radiopaque polyurethane tubing 110 cm long with two metal electrodes at the distal end. It is available with or without a latex balloon for flotation guidance and with or without a contamination shield, and is supplied sterile for single use.

The device uses polyurethane catheter material, latex balloon (in balloon-guided models), and polyvinyl chloride contamination shield (not in body contact). It is 110 cm in length, available in 4, 5, 6, and 7 French sizes, sterilized by ethylene oxide, and has the same basic design, construction, and materials as the predicate Pacel™ Flow Directed Pacing Catheter.

ISO 10993-1:2018 for biocompatibility assessment; FDA Good Laboratory Practice Regulations (21 CFR Part 58); OECD Series on Principles of Good Laboratory Practice (GLP). A subacute GLP animal study was performed in lieu of chronic toxicity testing.

The device is substantially equivalent because it has identical indications for use (temporary transvenous right ventricular pacing), identical materials (polyurethane catheter, latex balloon, PVC shield), identical dimensions (110 cm length, same French sizes), identical sterilization method (ethylene oxide), and comparable technological design to the predicate. Biocompatibility testing passed ISO 10993-1:2018 requirements with no systemic toxicity observed in animal studies. Retrospective clinical data from 85 patients demonstrated 100% pacing success rate and 100% complication-free rate with no adverse events.