Benchtop and Initial Clinical Evaluation of the ShockPulse Stone Eliminator in Percutaneous Nephrolithotomy

Standardized bench testing of the new ShockPulse™ intracorporeal lithotripter was performed against three commercially available lithotripsy systems to determine differences and nuances in performance.

The ShockPulse intracorporeal lithotripter was tested against the LUS-2™, CyberWand,™ and EMS LithoClast™ in a standardized bench setting using hard (Ultracal-30) and soft (plaster of Paris) stone phantoms. An in vitro kidney model was used to record the time needed to fragment stone samples into retrievable-sized pieces. The time needed to fully comminute and evacuate stone samples was also recorded. The efficacy of each device at various applied pressures was determined using a hands-free apparatus, which was used to apply 1.0, 1.5, and 2.0 pounds of fixed force.

For hard and soft stones, the time needed to create retrievable fragments was similar among all systems (p = 0.585). The ShockPulse was significantly faster than the LUS-2 and LithoClast at fully fragmenting and evacuating stone samples (p = 0.046), while the CyberWand was significantly slower than all three systems at this task (p = 0.001). When fixed forces were applied to a large stone phantom, the ShockPulse and CyberWand were significantly faster than the LUS-2 and LithoClast (p < 0.0001). When groups of smaller stones were tested, the ShockPulse was significantly faster at 1.0 pound (p < 0.001) and 1.5 pounds (p < 0.002) of force. At 2.0 pounds, no differences were observed (p = 0.09).

The ShockPulse is equally as effective and, in some circumstances, more effective than the three commercially available devices against which it was tested in an in vitro setting.