Sonablate® HIFU
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lichtenstein, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom
For the design, manufacture, and final inspection of medical devices for imaging and therapeutic ultrasound devices, including sterile and non-sterile insertion packs, for ultrasound imaging and energy delivery for soft tissue ablation issuing software for planning and ablation tracking.
Canada
Treatment of Prostate Disease including BPH, localized prostate cancer, and recurrent prostate cancer.*
United States
High-intensity ultrasound system for prostate tissue ablation
Argentina
Minimally invasive treatment of prostate disease using HIFU, high-intensity focused ultrasound, guided by transrectal ultrasound
Bahamas
Prostate Cancer
Bermuda
Prostate Disease
Colombia
Minimally invasive treatment of prostate disease using HIFU, high-intensity focused ultrasound, guided by transrectal ultrasound
Costa Rica
BPH and Prostate Cancer
Dominican Republic
BPH and Prostate Cancer
Ecuador
Ultrasound Therapy
Trinidad and Tobago
For the design, manufacture, and final inspection of medical devices for imaging and therapeutic ultrasound devices, including sterile and non-sterile insertion packs, for ultrasound imaging and energy delivery for soft tissue ablation issuing software for planning and ablation tracking.
Iran
Prostate Treatment
Israel
Prostate Treatment
Australia
Sonablate is intended for the minimally invasive treatment of prostate disease using transrectal ultrasound-guided HIFU, high intensity focused ultrasound.
China
The product intended use is for ablation treatments of local, low and medium-risk prostate cancer with no lymph node and distant metastasis within T2 stage; and benign prostatic hyperplasia (BPH) that has caused urinary dysfunction (IPSS>13, PV<80ml, protrusion of middle lobe into bladder < 1 cm). It is not intended use for lesions located in the anterior tip of the prostate tissue and in front of the urethra, and other focal points cannot be reached or acoustic power blocked by organs. The product must be used by qualified and trained clinicians in medical institutions.
Hong Kong
Ultrasound Therapy Systems
Japan
BPH
Macau
Ultrasound Therapy Systems
Malaysia
The Sonablate® is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.
South Korea
Soft Tissue Ablation
Taiwan
High Intensity Focused Ultrasound (HIFU) ablation of prostatic tissue
- localized primary prostate cancer
- localized recurrent prostate cancer
(Gleason score 6-9 and stage T1c-3bN0M0 and prostate-specific antigen (PSA) of_30ng/ml)
Vietnam
Ultrasound Diagnostic and Treatment
Sonablate® has received approval in over 50 countries worldwide. In the United States, Sonablate is indicated for the ablation of prostate tissue. For specific indications per country, visit www.sonablate.com/indications.
As with any medical procedure, individual results may vary. Most common side effects include pain and discomfort and urinary tract infection (UTI). Rare side effects include rectal injury, which may require intervention. Consult the Instructions for Use (IFU) for more information.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Sonablate is a registered trademark of Sonablate Corp.
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