Solo Pace Fusion System (SOLOFUSE1)

The Solo Pace Fusion System is a catheter guidewire designed to introduce and position interventional devices within the heart chambers, particularly for transcatheter aortic valve replacement procedures. It can also deliver temporary intracardiac pacing by transmitting electrical signals from the Solo Pace Control external pulse generator to the heart.

The Fusion Guidewire is 275 cm long with 0.035" diameter stainless steel shaft, PTFE coating on the shaft, silicone-coated pigtail tip, and unipolar electrode design. It connects via a unique Fusion Connection Cable to a Fusion Ground Pad (anode) for pacing. Key differences from predicate SavvyWire include the silicone tip coating (versus none) and the dedicated Fusion Ground Pad grounding method (versus alligator clip to needle).

Biocompatibility testing followed ISO 10993-1 (Biological Evaluation of Medical Devices). Animal safety studies complied with 21 CFR Part 58 Good Laboratory Practice (GLP) for non-clinical laboratory studies, conducted in a porcine model.

The Solo Pace Fusion System shares the same fundamental scientific technology as the predicate SavvyWire and reference Wattson device. Biocompatibility, benchtop, animal, and usability studies demonstrated similar safety and performance profiles with no new safety or effectiveness concerns compared to the predicate device. The 10-patient FIH usability study showed acceptable performance (4.97/5.0 scores) with typical TAVR delivery systems.