Focal One High-Intensity Focused Ultrasound (HIFU) represents an advanced, non-invasive medical technology transforming how certain conditions are managed. This innovative approach offers a precise method for addressing specific tissues within the body. It utilizes focused energy to achieve therapeutic effects without the need for surgical incisions. The technology aims to provide effective treatment while minimizing impact on surrounding healthy structures.
What is Focal One HIFU?
High-Intensity Focused Ultrasound (HIFU) concentrates sound waves to generate heat at a precise point within the body. Similar to how a magnifying glass focuses sunlight to create a hot spot, HIFU devices direct ultrasound energy with pinpoint accuracy. This focused energy elevates the temperature in the targeted tissue, causing cellular destruction through thermal ablation.
The Focal One system refines this technology by integrating a robotic platform for enhanced precision. It is specifically designed for the targeted ablation of prostate tissue, allowing for the destruction of diseased cells while sparing healthy surrounding areas. This robotic system ensures submillimetric accuracy, contributing to its non-invasive nature. The Focal One device combines high-performance imaging with HIFU technology, providing urologists with a precise and user-friendly tool.
How the Procedure Works
The Focal One HIFU procedure begins with patient positioning, typically under general or spinal anesthesia. A transrectal ultrasound imaging probe is then manually inserted to scan the entire prostate, generating a detailed three-dimensional reconstruction on the system’s screen. This high-resolution image allows for clear visualization of anatomical structures.
For enhanced accuracy, diagnostic images such as multiparametric MRI or 3D biopsy maps can be seamlessly imported and fused with real-time ultrasound. This fusion creates a combined image where target areas are precisely overlaid onto the live ultrasound. The urologist then meticulously plans the treatment, defining the upper and lower limits of the target area in virtual slices, ensuring a safety margin around the lesion while avoiding sensitive structures.
Once the treatment plan is finalized, the Focal One robotic system takes over, executing the plan with submillimetric precision. The system automatically adjusts in real-time to maintain optimal positioning and delivers high-intensity ultrasound pulses to the targeted cells. These focused sound waves generate localized heat, causing the cells in the treatment area to ablate without requiring incisions or radiation. Throughout the process, the urologist maintains continuous control and monitors the ablation through real-time visualization, with the ability to pause and readjust the plan as needed.
Conditions Treated and Patient Suitability
Focal One HIFU is primarily utilized for the localized treatment of prostate cancer, offering an alternative to more invasive therapies. It is particularly considered for men with early-stage prostate cancer that is confined to the gland.
Suitable cases include localized stage T1 or T2 cancer, where the disease has not spread beyond the prostate. Patient suitability involves a Gleason score of 7 or less, indicating a less aggressive form of cancer. A Prostate-Specific Antigen (PSA) level typically at or below 20 ng/mL is often a consideration for treatment. The technology is well-suited for patients who desire to preserve their quality of life, as it aims to minimize side effects associated with more extensive treatments.
Specific criteria for candidacy include visible index lesions on multiparametric MRI. Contraindications for the procedure can include previous anal or rectal surgery that prevents probe insertion, or the presence of artificial sphincters, penile implants, or intra-prostatic implants.
Patient Experience and Recovery
The Focal One HIFU procedure is typically performed on an outpatient basis, allowing patients to return home the same day. Before the procedure, patients generally complete a bowel preparation. The procedure itself is conducted under general or spinal anesthesia to ensure patient comfort and minimize movement.
Following the procedure, patients usually spend a few hours in a recovery room before discharge. A temporary urinary catheter is commonly placed to manage potential swelling and ensure proper bladder drainage, remaining in place for a few days to a couple of weeks. This catheter is removed during a follow-up visit.
Patients can expect a relatively quick recovery, able to resume light activities within a few days to a week. Full normal physical activity is often possible within two weeks.
Common temporary side effects include mild discomfort or soreness in the perineal area, increased urinary frequency or urgency, and mild burning sensations during urination. Some individuals may also notice blood in their urine or semen for a few weeks, which is generally harmless. While erectile dysfunction is rare, temporary changes to erections may occur but often improve as the prostate heals. Follow-up care typically involves regular PSA testing and imaging to monitor treatment effectiveness.