High-Intensity Focused Ultrasound (HIFU) is an FDA-approved, minimally invasive prostate procedure that uses high-intensity sound waves to heat and destroys prostate tissue, thereby avoiding the need for surgery or radiation. HIFU allows physicians to treat the entire prostate or to target only specific areas of concern, thus sparing surrounding and sensitive structures that cause undue morbidity.
Benefits of this prostate procedure, HIFU, include:
- FDA clearance
- Medicare coverage
- No surgery or radiation
- Outpatient procedure with no hospital stays
- Single treatment typically 2-3 hours
- Quick return to ADL
- Low risk of incontinence and erectile dysfunction
The Sonablate HIFU system received FDA Clearance for Prostate Tissue Ablation in November 2015. Since launching Sonablate, the device/procedure continues to gain positive momentum at academic medical facilities, hospitals, and surgery centers throughout the US. Today, over 100 urology physicians have enrolled in Sonablate HIFU training, and 4,500+ HIFU procedures have been performed in the US (20,000 worldwide), including whole-gland, Hemi–gland, and focal prostate ablations using MR/Ultrasound-fused image guidance. And now with emerging new clinical outcomes data for Sonablate HIFU and Medicare Coverage for prostate HIFU, patient interest is accelerating and new physicians and clinical centers are needed.
Peer-Reviewed Library from SonaCare Medical
- Sonablate® 500 has CE Marking and has obtained regulatory authorization in more than 50 countries outside the U.S.
- Sonablate® has 510(K) clearance in the U.S. and is indicated for the transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
- Sonatherm® laparoscopic HIFU surgical ablation system has 510(K) clearance in the U.S., CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S. Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. Sonatherm is not to be used to spare intervening tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.