The U.S. Food and Drug Administration has granted de novo clearance for the Sonablate 450 focused ultrasound system for transrectal high-intensity focused ultrasound (HIFU) ablation of prostate tissue. Focused ultrasound enables treatment of organ-confined prostate disease while preserving the surrounding healthy tissue, and does not require radiation or surgery.
A news release from the product's manufacturer, SonaCare Medical, notes that Sonablate is the first HIFU device to receive FDA regulatory authorization for prostate tissue ablation.
“We are at a pivotal point in prostate care,” Michael Koch, MD, Chairman of the Department of Urology at Indiana University and one of the researchers involved in the device's clinical trial, said in a news release. “Simultaneous advances in imaging, fusion technologies, and now more focused therapies are going to allow us to precisely diagnose prostate conditions, and ablate these targeted areas rather than perform whole-gland prostate surgery, which carries a significant burden on quality of life. HIFU will become the work-horse of subtotal prostate therapy.”
How the System Works
To use the device, the physician directs a focused beam of ultrasound energy to a selected volume in the patient's prostate gland, using real-time image guidance. The energy heats the targeted tissue at the focal point and thermally coagulates the targeted cells within seconds. The procedure can be repeated if necessary because no radiation is involved. And recovery time is typically shorter than surgery because the procedure requires no incisions, according to SonaCare.
Safety and Efficacy
The de novo clearance for Sonablate 450 is based on data from a non-randomized, prospective, single-arm study of 117 men with locally recurrent, non-metastatic prostate cancer who had previously undergone external-beam radiation therapy to the prostate.
The men underwent gland salvage focused ultrasound ablation of their prostate following recurrence of their disease. Among the 73 patients who had prostate volumes determined both pre- and post-ablation, the mean reduction in volume was 11.8 cm3; and of the 44 patients who did not have volumes calculated post-ablation, there was only a single case of a positive biopsy. Of the total cohort, 97 men had a reduction in PSA post-ablation and 71 men had a negative post-ablation biopsy.
The most serious adverse event reported with use of the device was osteomyelitis. Other adverse events were erectile dysfunction, urinary tract infection, urinary incontinence, hematuria, urinary retention, urinary frequency, urinary urgency, urinary tract obstruction, dysuria, urethral stricture, epididymitis/orchitis, bladder neck contracture, rectal fistula, and urinary fistula.
The procedure is also currently approved in the U.S. to treat uterine fibroids and relieve pain from bone metastases.
Clinical Quick Facts: Sonablate 450
Device: Sonablate 450
Approved Indication: Transrectal high-intensity focused ultrasound ablation of prostate tissue
Serious Side Effects: Osteomyelitis
Other Side Effects: Erectile dysfunction, urinary tract infection, urinary incontinence, hematuria, urinary retention, urinary frequency, urinary urgency, urinary tract obstruction, dysuria, urethral stricture, epididymitis/orchitis, bladder neck contracture, rectal fistula, and urinary fistula.