EDAP TMS has submitted a pre-market approval (PMA) application to the US Food and Drug Administration (FDA) seeking approval to use its high intensity focused ultrasound (HIFU) device to treat patients with low risk, localised prostate cancer under general or spinal anesthesia.
The Ablatherm-HIFU device features a treatment module, a control table with a computer and a diagnostic ultrasound device.
The device, upon insertion through the endorectal, aids physicians to visualise 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, according to the company.
The PMA application included data from the company’s multi-centre, US Phase II/III Enlight study that completed the two-year follow-up needed to evaluate its primary endpoint, 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.
"Ablatherm-HIFU is well positioned to address this unmet medical need by providing a unique non-invasive and fully robotic treatment option.
"The PMA submission to the FDA represents a significant milestone in the US regulatory process for Ablatherm-HIFU."
The company said that 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.