Market Overview

Minimally Invasive Treatment for Prostate Cancer Receives FDA Clearance


Sarasota urologist, Dr. Tracy Gapin, has extensive experience using the HIFU device cleared for the ablation of prostate tissue.

Sarsota, FL (PRWEB) October 14, 2015

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.

For more information about HIFU, contact Dr. Tracy Gapin online by visiting the Sarasota Prostate Care website or call (941) 329-7888. Dr. Gapin's office is located at One South School Avenue, Suite 200, Sarasota, FL 34237.

About Sarasota Prostate Care
A division of Florida Urology Specialists, Sarasota Prostate Care is a state-of-the-art, patient-focused center, committed to providing the most effective options available for the diagnosis and treatment of prostate cancer. Headed by Dr. Tracy Gapin, Sarasota Prostate Care offers advanced prostate cancer diagnosis including 3T prostate MRI, MRI/Ultrasound 3-D Fusion Prostate Biopsy, and whole gland and focal HIFU for cutting edge treatment of prostate cancer. Dr. Gapin was the first surgeon to perform a da Vinci robotic prostatectomy in Sarasota as well as the first surgeon to integrate DaVinci-S robotic technology in Florida. For more information, call (941) 329-7888 or visit online at

About SonaCare Medical
SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

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