A precise, minimally invasive treatment with a lower risk of side effects.
Ultrasound treatment (HIFU)
Focal One® - Robotic Focal HIFU treatment
Focal One is a medical device used to treat localized prostate cancer by ultrasound (HIFU), subject to certain criteria. The energy is delivered through a probe (transducer), which can both locate the tumor by ultrasound and deliver the ultrasound waves. This device allows medical staff to include external imaging (for example MRI and soon other images) and to merge this image with the one obtained in real time. HIFU treatment can thus be applied to all or part of the prostate, depending on the tumor and treatment conditions. The target area destroyed by each probe pulse is elliptical and measures 5 mm high with a diameter of 1.7 mm. The brevity of this pulse prevents the heat from spreading outside the target zone. Treatment lasts between 30 and 90 minutes and can be administered under locoregional anesthesia.
When medically indicated, the technological advantages of Focal One – minimally invasive, precise, and ablative – make it a useful new option between active monitoring and more radical treatment. This strategy aims to control the disease with fewer risks of side effects.
Who can benefit from Focal One treatment?
HIFU treatment may be suggested in cases of localized prostate cancer, low risk of progression, not eligible for active monitoring, or intermediate risk, or in cases of local recurrence after radiotherapy.
Are there any contraindications?
Patients whose prostate obstructs the normal flow of urine may benefit from endoscopy to reduce gland volume, when indicated by the urologist. For patients whose rectal wall has been thickened by prior treatments (rectal surgery, radiotherapy), HIFU treatment may not be recommended: your urologist will provide you with full information.
For more information
HIFU treatment: advantages for the patient
Treatment of localized prostate cancer with High-Intensity Focused Ultrasound (HIFU) is considered a minimally invasive procedure, meaning that no incision is made and therefore no scar is left.
HIFU treatment procedure
Treatment is administered in a single session, under general or locoregional anesthetic, as the patient and anesthetist deem most appropriate. The patient is positioned lying down on their right side (in a fetal position).
HIFU treatment results
In 2024, a published French trial(1) including more than 3300 patients enrolled at 46 sites proved the non-inferiority of HIFU treatment compared with standard surgery, in terms of oncological results at 30 months.
LEGAL NOTICE – INS-491G – 2022/04/28 – 394 804 447 RCS Lyon
Focal One is manufactured by EDAP TMS. This medical device is a regulated health care product, which bears CE marking in accordance with this regulation. Focal One is intended to use high-intensity focused ultrasound introduced via the rectum to destroy localized prostate adenocarcinoma. You must consult with your urologist.