11.09.15
Lyon, France-based EDAP TMS SA, which makes therapeutic ultrasound technology, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Ablatherm integrated imaging HIFU (high-intensity focused ultrasound) in the United States for the ablation of prostate tissue. EDAP expects to commercialize Ablatherm HIFU in the United States immediately.
“This is a tremendous achievement for the Company and the result of many years of hard work from our team,” said CEO Marc Oczachowski. “This clearance represents a unique opportunity for EDAP and its superior HIFU technology to penetrate the largest prostate market in the world in the same way it has emerged as the leading HIFU technology in Europe. With an established US sales and services infrastructure, the pieces are in place to begin deploying Ablatherm devices in the U.S. very quickly and we look forward to bringing the technology to urologists as well as patients in need.”
Ablatherm provides for high-intensity focused ultrasound treatment of localized prostate cancer. HIFU treatment has been shown to be a minimally invasive and effective option for prostatic tissue ablation 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.
“This is a tremendous achievement for the Company and the result of many years of hard work from our team,” said CEO Marc Oczachowski. “This clearance represents a unique opportunity for EDAP and its superior HIFU technology to penetrate the largest prostate market in the world in the same way it has emerged as the leading HIFU technology in Europe. With an established US sales and services infrastructure, the pieces are in place to begin deploying Ablatherm devices in the U.S. very quickly and we look forward to bringing the technology to urologists as well as patients in need.”
Ablatherm provides for high-intensity focused ultrasound treatment of localized prostate cancer. HIFU treatment has been shown to be a minimally invasive and effective option for prostatic tissue ablation 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.