FDA News

FDA approves Ablatherm HIFU treatment for prostate cancer

The FDA has fully approved the Ablatherm high-intensity focused ultrasound device for the nonsurgical and noninvasive treatment of localized prostate cancer, according to a press release from the device’s manufacturer.

Ablatherm high-intensity focused ultrasound (EDAP TMS), or Ablatherm HIFU, is recommended for men with localized prostate cancer (stages T1-T2) who are not candidates for surgery, who prefer an alternative option or who failed radiotherapy treatment.

The device targets the tumor via a computer-controlled rectal probe. Ultrasound waves are intended to destroy the prostate tissue while sparing surrounding organs. Data have indicated the device is effective for prostatic tissue ablation with a low occurrence of side effects, according to the press release.

Ablatherm HIFU is a single treatment; however, it can be used more than once if needed.

“Ablatherm HIFU has the best patient safety outcomes by far and cure rates are excellent,” William Orovan, MD, professor of urology and urological oncology at McMaster University, said in a release from Maple Leaf HIFU, a treatment center of Cleveland Clinic Canada that uses Ablatherm HIFU. “Side effects of HIFU, including incontinence and erectile dysfunction, are much less than traditional surgery or radiation.”

The FDA has fully approved the Ablatherm high-intensity focused ultrasound device for the nonsurgical and noninvasive treatment of localized prostate cancer, according to a press release from the device’s manufacturer.

Ablatherm high-intensity focused ultrasound (EDAP TMS), or Ablatherm HIFU, is recommended for men with localized prostate cancer (stages T1-T2) who are not candidates for surgery, who prefer an alternative option or who failed radiotherapy treatment.

The device targets the tumor via a computer-controlled rectal probe. Ultrasound waves are intended to destroy the prostate tissue while sparing surrounding organs. Data have indicated the device is effective for prostatic tissue ablation with a low occurrence of side effects, according to the press release.

Ablatherm HIFU is a single treatment; however, it can be used more than once if needed.

“Ablatherm HIFU has the best patient safety outcomes by far and cure rates are excellent,” William Orovan, MD, professor of urology and urological oncology at McMaster University, said in a release from Maple Leaf HIFU, a treatment center of Cleveland Clinic Canada that uses Ablatherm HIFU. “Side effects of HIFU, including incontinence and erectile dysfunction, are much less than traditional surgery or radiation.”