high-intensity focused ultrasound (HIFU)

Product Name: Ablatherm® Integrated Imaging Sonablate® 500
Country: Austria (AT)

Ludwig Boltzmann Institut für Health Technology Assessment

Outcome Measure

a. Efficacy: Clinical (surrogate parameters): PSA-kinetics, histology; patient-relevant outcomes: 5-year survival, disease-free survival, overall survival, quality of life<br>b. Safety: Morbidity: acute/ chronic urinary dysfunction, urinary incontinence, strictures/ stenosis (bladder neck, ureter), erectile dysfunction, recto-urethral fistula, chronic pain, mortality (p. 13)

Body Classification

Male Reproductive System

Device Type

Therapeutic device

Device Category

Treatment of disease

Risk Classification

IIa

Indication

localized prostate cancer

ICD-10

C61

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