high-intensity focused ultrasound (HIFU)

Product Name: Ablatherm®, Sonablate®
Country: France (FR)

Haute Autorité de Santé

Outcome Measure

a. Efficacy: mortality, side effects, long term survival (-overall, -cancer-specific, -without metastasis, -without second treatment, -without biochemical or disease relapse), long-term side effects, quality of life (p. 6)<br>b. Safety: Operative and postoperative complications (p. 6)

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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