A new electromagnetic shock-wave generator “SLX-F2” with user-selectable dual focus size: ex vivo evaluation of renal injury

Abstract

Storz Medical AG (Kreutzlingen/Switzerland) has developed a new electromagnetic shockwave (SW) generator, the "SLX-F2", which allows the user to choose between a small-focus, high-pressure treatment regime or a wide-focus, low-pressure option. The aim of this study was to investigate, under standardized conditions, the impact of these two different treatment regimes on SW-induced renal injury. SW-induced renal injury was investigated by using the standardized model of the perfused ex vivo kidney. SWs were applied under ultrasound control in the parenchyma of a kidney pole. Different SW numbers (20, 50, 125, 250, 500, 1,000) were applied in three groups: group A was treated with a wider focus (80 MPa), groups B (60 MPa) and C (120 MPa) with a smaller focus (each parameter setting was repeated ten-fold). Disintegration capacity (measured by crater volume in cubes of plaster of Paris) was the same in groups A and C. After SW exposure, barium sulphate suspension was perfused through the renal artery. The maximum diameter (mm) of the extravasation in the cortex, representing the extent of vascular injury, was measured on X-ray mammography films. H&E staining was performed. In all three groups (A, B, C) a higher number of SWs caused the diameter of the extravasate to increase, with statistical significance appearing at 1,000 shots versus 20 shots (p < 0.05). Vascular injury was not influenced by the focal size and positive peak pressure at identical SW numbers applied. Histology of the focal area showed gap-like defects. Our ex vivo data show that renal vascular injury is independent of the focal diameter of the SW generator at the same peak positive pressure and disintegration power. This confirms the in vivo findings that show renal injury caused by SW as being related to the number of SWs administered. Clinical studies are needed to investigate whether there is any advantage to offering both treatment regimes in one SW machine-for example, by using the "wide-focus, low-pressure" option for kidney stones and the "small-focus, high-pressure" regimen for stones in the ureter. The renal injury caused by either regime remains comparable.

Treatment of Moderate-sized Kidney Stone with Third-generation Electromagnetic Shock Wave Lithotripter

“…ESWL is a preferred method in many clinical centers due to its low invasiveness, lower complication rate, and method effectiveness. In the last two decades, the emphasis has been on the development of electromagnetic shock wave lithotripters, which are more durable, with variations in the size of the focus zone and are aimed at improving the safety and efficacy of treatment [8], [9].…”

Comparison of Broad vs Narrow Focal Width Lithotripter Fields

“…[5][6][7][8] The renewed interest in clinical shockwave lithotripters with broad beam size has heightened the awareness and urgency in addressing this issue. [9][10][11][12] Previously, stone comminution produced by different types of lithotripters with various beam sizes has been studied at clinically relevant output settings. [13][14][15] However, inherent lithotripter differences in acoustic fields, coupling methods, stone localization techniques, and output settings make it impossible for an objective and direct comparison.…”