PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones

Exclusion Criteria23

• BMI \> 29.9
• Target stone that cannot be localised
• Multiple kidney stones in the target kidney
• Stones with a density value of \> 1,200 HU
• Skin to stone distance (SSD) \> 160 mm
• The presence of obstructions, malformations or other factors preventing targeting or passing of the stone, including but not limited to the following:
• Skeletal malformations and obesity, preventing targeting of the stone
• Malignant tumour in the shockwave path
• Arterial aneurysm or calcium deposits, or thrombosis in shockwave path
• Brain, spinal column or air-filled tissue, especially the lungs, in the shockwave path
• Obstruction distal to the stone (as this would hinder the passage of fragments through collecting system or ureter)
• Any disease/medical condition, prior or concomitant medication/treatment/intervention, or implant that may affect this clinical investigation, and/or is contraindicated for the IMD, including but not limited to the following:
• Severe nephrocalcinosis
• Uncontrolled urinary tract infection
• Coagulation disorders and bleeding diathesis, not compensated according to urological and hemostaseological guidelines
• Anticoagulation or platelet inhibition therapy, not bridged according to urological and hemostaseological guidelines
• Uncontrolled hypertension
• Blood pressure \> 180/100
• Active cardiac implants that are not authorized for use with ESWL
• Pancreatitis
• Ehlers-Danlos syndrome
• Administration of contrast agents containing gases for ultrasound diagnostics less than 24 hours before treatment.
• Pregnancy