The Lyon, France-based medical device company said the high-intensity focused ultrasound device is designed to treat low-risk, localized prostate cancer. The PMA submission is backed by data from Edap’s Enlight study, according to a press release.
"We have clearly seen a paradigm shift in prostate cancer, as patients are diagnosed earlier than ever before. Low-risk patients need a middle ground between radical treatment, which is often overly-aggressive, and the anxiety of ‘watchful waiting.’ Ablatherm-HIFU is well-positioned to address this unmet medical need by providing a unique non-invasive and fully robotic treatment option," CEO Marc Oczachowski said in prepared remarks.
The Ablatherm-HIFU device is already approved in the European Union, South Korea, Canada, Australia, South Africa, New Zealand, the Philippines, Taiwan, Mexico, Argentina, Brazil and Russia, according to the release.