SWL literature
SWL Literature

MODULITH SLX-F2: New SWL indications 510 (k) FDA cleared - Treatment of children and ureteral stones

MODULITH_SLX-F2

The established and US-market leading MODULITH SLX-F2 extracorporeal shock wave lithotripter from STORZ MEDICAL has recently received the FDA 510 (k) clearance for new indications. With this clearance, an absolutely unique selling point for STORZ MEDICAL is that children over the age of three years suffering of stone disease can now be treated non-invasively(*1,2, 3). The MODULITH SLX-F2 is the first and the only lithotripter available for lithotripsy in children in the USA.

»As the incidence of stone disease in children and teenagers is rising constantly not only in the USA, we are happy to offer the non-invasive treatment option of SWL with very low side effects (*4) to our customers and their small patients« claims a delighted Peter Schmid, STORZ MEDICAL’s Director International Sales.

Furthermore, in addition to the treatment of kidney stones and stones in the proximal ureter, it is now also possible to treat urinary stones in the middle and distal ureter. This offers doctors excellent new ways of successfully treating their patients, as studies show success rates and stone-free rates of more than 90% (*5) for ureteral stones treated with extracorporeal shock wave lithotripsy.

Sources:

(*1) EAU Guidelines 2018: Extracorporeal shock wave lithotripsy remains the least-invasive procedure for stone management in children [414-417].
Stone-free-rates of 67-93% in short-term and 57-92% in long-term follow-up studies have been reported. In children, compared with adults, SWL can achieve more effective disintegration of large stones, together with swifter and uncomplicated discharge of large fragments [414, 418].

(*2) AUA Guidelines 2016: 50. In pediatric patients with a total renal stone burden ≤20mm, clinicians may offer SWL or URS as first-line therapy. (Index Patient 14) Moderate Recommendation; Evidence Level Grade C
SWL has a long track record of success in treatment of renal stones in children. Stone-free rates are reported [213,214] to be relatively high in children at 80-85% overall, and at 80% for lower pole stones.

(*3) Grabsky A, Tsaturyan A, Musheghyan L, Minasyan G, Khachatryan Y, Shadyan G, Qocharyan A, Mosoyan M, Kallidonis P. Effectiveness of ultrasound-guided shockwave lithotripsy and predictors of its success rate in pediatric population: A report from a national reference center. J Pediatr Urol. 2021 Feb;17(1):78.e1-78.e7.

(*4) Razvi, H. et al, JoE 2012: Risk Factors for Perinephric Hematoma Formation After Shock Wave Lithotripsy 2012

(*5) Tiselius, H.G., JoE 2008: How Efficient Is Extracorporeal Shockwave Lithotripsy with modern lithotripters for removal of ureteral stones?
Stone-free ureters were recorded in 563 (97.1%) patients. Stone-free rates were 96.1%, 97.8%, and 97.9%, for the proximal, middle, and distal ureter, respectively.

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