EDAP TMS has filed a pre-market approval (PMA) application with the US Food and Drug Administration (FDA) for approval of its non-invasive, fully robotic Ablatherm-high intensity focused ultrasound (HIFU) device, designed to treat patients with low risk, localized prostate cancer.
Featuring a treatment module, a control table with a computer and a computer screen, and a diagnostic ultrasound device, the device is inserted into the endorectal to help physicians visualize the prostate and use automated transducer to treat each predefined lesion.
The integrated imaging system within the device also helps in controlling and imaging the treatment in real time, claims the company.
The PMA application included data from the company’s multi-center, US Phase II/III Enlight study, as well as data from the extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.
EDAP TMS chief executive officer Marc Oczachowski said the company has 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’," Oczachowski added.
The company said the ultrasound-guided HIFU device is cleared for distribution in the European Union, South Korea, Canada, Australia, South Africa, New Zealand, the Philippines, Taiwan, Mexico, Argentina, Brazil and Russia.