The FDA has cleared a nonsurgical, minimally invasive treatment for prostate tissue ablation. This is the first High Intensity Focused Ultrasound (HIFU) device to receive FDA regulatory authorization for prostate tissue ablation.
SonaCare Medical, a global leader in high-intensity focused ultrasound ablation devices, has received regulatory authorization through the FDA de novo process to market and sell Sonablate® in the U.S. for the ablation of prostate tissue.
HIFU is a precise, non-invasive, prostate therapy that delivers controlled thermal energy through a rectal ultrasound probe to precisely destroy prostate tissue. HIFU is an outpatient procedure that takes 2-4 hours to complete. With HIFU, men are able to quickly return to normal activities. The treatment is typically associated with minimal treatment-related side effects.
Dr. Tracy Gapin, a urologist in Sarasota, FL at Sarasota Prostate Care, is one of a handful of specialists who have extensive experience treating patients with HIFU using the SonaCare Sonablate® device. He has been bringing men to the Bahamas and Grand Cayman for HIFU treatments for many years.
“Men undergoing prostate cancer treatment are very concerned with preserving normal sexual and urinary function,” said Dr. Gapin. “HIFU enables very precise prostate ablation with nominal effect on other nearby structures. This enables excellent treatment outcomes with minimal side effects such as urinary incontinence, erectile dysfunction, or loss of ejaculate” Gapin added.
HIFU’s excellent outcomes, quick recovery and minimal risk of side effects has made it the treatment of choice for more than 40,000 men in countries across the globe. More than 7,000 men in the U.S. have travelled abroad to receive HIFU treatment.
“My patients love the ability to quickly get back to their normal life after HIFU treatment and I am pleased to be able to offer patients a prostate cancer option that does not carry a significant burden to their quality of life,” said Gapin. “I expect that FDA clearance of the HIFU device will have a profound effect on prostate care in the U.S.,” added Gapin.