Edap TMS, a medical device manufacturer based in Lyon, France, announced that it had submitted a premarket approval application with the United States Food and Drug Administration for its Ablatherm-HIFU, a prostate cancer treatment system.
According to a press release by the company, the focused high-intensity ultrasound device is designed for the treatment of prostate cancer. In particular, the device specializes in the treatment of localized prostate cancer that poses a minimal health risk. The company also stated that its PMA is backed by the Enlight clinical study of the device.
Marc Oczachowski is the CEO of Edap TMS. In prepared remarks, he said, "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.”
As of now, the Ablatherm-HIFU is approved in South Korea, South Africa, the Philippines, Mexico, Australia, New Zealand, Canada, the European Union, Russia, Brazil and Argentina.