Focal One
Robotic system for the focal treatment of prostate cancer
Focal One is a high-intensity focused ultrasound (HIFU) robotic system for the focal treatment of prostate cancer.
Made by
The three pillars of focal therapy (HIFU)
Tumour location
Tumour location based on MRI and confirmed by biopsy, along with biopsy locations and results, guide focal therapy with Focal One, thanks to a patented, non-rigid fusion algorithm (HIFUsion).
Clinically-proven ablation technology
Visualisation of the devascularised area by contrast-enhanced ultrasound and magnetic resonance imaging.
Validation of treatment efficacy
The Focal One system is equipped with built-in software and hardware to view contrast-enhanced ultrasound images. After administering an ultrasound contrast agent, this functionality is used to check the completeness and effectiveness of the treatment in progress and to promptly correct and assimilate the location of HIFU lesions, in real time, before the procedure is considered to be finished.
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System operation
- Focal One delivers eight focal points of action. The high number of points available, together with the cylindrical shape of the focal point, ensures greater precision and a greater likelihood of success, while minimising the risk of untreated areas within the target area.
- The Focal One probe boasts dynamic focusing technology. The system automatically adapts to the treatment of the entire target area (robotic system).
- The Focal One offers real-time ultrasound imaging. The area to be treated can be dynamically and continuously controlled and potentially optimised for the entire duration of the procedure.
- The pulse delivery time is 1 second. This shortens the length of time critical tissue, such as the rectal wall, is exposed to high temperatures, thereby reducing treatment times and, consequently, the strain on operating theatres.
- The HIFUsion imaging software is built in to the system.
- The right lateral decubitus position required by Focal One guarantees that there are no air bubbles in the probe’s field of vision, so that the treatment is not affected.
Treatment protocols
Focal One is a high-intensity focused ultrasound (HIFU) robotic system for the minimally-invasive treatment of prostate cancer according to defined inclusion criteria.
Low-risk patients
On active surveillance, PSA ≤10 ng/ml, Gleason score ≤6 and stage T1c or T2a.
Intermediate-risk patients
PSA 10-20 ng/ml, and/or Gleason score 7 (3+4) to Gleason 7 (4+3), and/or stage T2b.
The system can apply different treatment protocols, each with specific pre-set HIFU delivery intensities validated by clinical studies.
The protocols are:
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Treatment in the first instance
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Post-HIFU re-treatment
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Post-radiotherapy salvage therapy
The machine automatically adjusts the treatment to the selected protocol.
The treatment is robotically delivered, which therefore reduces possible administration errors as it is not operator-dependent.
The energy levels for each validated treatment protocol are pre-set and specific to the type of treatment to be delivered: energy delivery is adjusted to each individual patient according to the type of lesion to be treated.
Clinical benefits
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The treatment is minimally invasive, precise and highly ablative. It is a first-line treatment strategy that represents a compromise between NON-treatment (active surveillance) and a destructive approach such as radical prostatectomy.
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Treatment is administered in a single session and can be repeated as necessary.
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Focal One is equipped with imaging fusion software (HIFusion). It fuses images from multi-parametric magnetic resonance imaging (mpMRI) and biopsy systems, while administering an ultrasound contrast agent (SonoVue-sulphur hexafluoride) means that areas of necrosis can be controlled during the procedure.
Benefits for the patient
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Minimally-invasive treatment and focal therapy help maintain patient quality of life and continence levels.
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In addition, the treatment can be repeated: in fact, HIFU is the only post-radio salvage therapy recommended by the European Association of Urology (EAU).
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Taimur et al. “Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity score-matched study” Prostate Cancer and Prostatic Diseases 2021.
Courtez et al. “Whole-gland Ablation of Localized Prostate Cancer with High-intensity Focused Ultrasound: Oncologic Outcomesand Morbidity in 1002 Patients” EAU 2014; Courtez et al. “Locally recurrent prostate cancer after initial radiation therapy: Early salvage high-intensity focused ultrasound improves oncologic outcomes” The Green Journal 2012.
Shah et al. “Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity score-matched study” Prostate Cancer and Prostatic Diseases 2021.
Albissini et al. “Comparing HIFU hemiablation to robotic radical prostatectomy in the management of unilateral prostate cancer: a matched pair analysis”, J. Endourology 2016
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