07.30.14
Lyon, France-based EDAP TMS, a therapeutic ultrasound device company, has run up against a U.S. Food and Drug Administration (FDA) road block from the agency’s Gastroenterology and Urology Devices Panel. The panel of nine voted no on the questions of safety, efficacy and risk/benefit ratio for the use of EDAP’s Ablatherm-HIFU device for the treatment of low-risk, localized prostate cancer.
“We are disappointed by the committee’s recommendation regarding Ablatherm-HIFU for the treatment of low-risk, localized prostate cancer and we appreciate the dialogue during today’s meeting,” said CEO Marc Oczachowski. “We look forward to subsequent discussion with the FDA. We will continue to work diligently with the FDA as it carefully completes its final review for Ablatherm-HIFU’s pre-market approval.”
Prostate cancer is the most prevalent form of cancer in men with approximately 233,000 new cases diagnosed in the United States and approximately 380,000 in Europe each year.
The FDA is not bound by the panel’s recommendation but will consider the committee’s guidance in reviewing the pre-market approval application for Ablatherm-HIFU.
EDAP TMS markets Ablatherm for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. According to the company, HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved and commercialized in Europe as a treatment for prostate cancer.
“We are disappointed by the committee’s recommendation regarding Ablatherm-HIFU for the treatment of low-risk, localized prostate cancer and we appreciate the dialogue during today’s meeting,” said CEO Marc Oczachowski. “We look forward to subsequent discussion with the FDA. We will continue to work diligently with the FDA as it carefully completes its final review for Ablatherm-HIFU’s pre-market approval.”
Prostate cancer is the most prevalent form of cancer in men with approximately 233,000 new cases diagnosed in the United States and approximately 380,000 in Europe each year.
The FDA is not bound by the panel’s recommendation but will consider the committee’s guidance in reviewing the pre-market approval application for Ablatherm-HIFU.
EDAP TMS markets Ablatherm for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. According to the company, HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved and commercialized in Europe as a treatment for prostate cancer.