News | January 08, 2015

EDAP Receives FDA Guidance on Premarket Approval for Ablatherm-HIFU

Guidance provides specific recommendations for amendments to make PMA approvable

EDAP TMS SA, Ablatherm, FDA, PMA, premarket approval, guidance

Image courtesy of EDAP TMS SA

January 8, 2015 — EDAP TMS SA received a letter from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on its current premarket approval (PMA) application for the Ablatherm integrated imaging device for high-intensity focused ultrasound (HIFU). The FDA letter stated that while EDAP’s Ablatherm-HIFU PMA is not approvable in its current form, it provides specific guidance and recommendations as to a path forward. This guidance was provided in accordance with the requirements of 21 CFR 814.44(f), which states that the FDA, where practical, must identify measures necessary to make the PMA approvable.

Consistent with feedback received during the Gastroenterology and Urology Devices Panel meeting, the FDA has recommended considering a modified indication for use in a population of localized prostate cancer patients that have greater risk of morbidity and/or mortality from their disease. The FDA made further recommendations regarding the potential use of the company’s European registry, along with the already existing safety data from the previous U.S. investigational device exemption (IDE), to support approval for the modified indication. Although additional data and analyses will be necessary to address FDA’s requests, the letter did not require a new U.S. IDE study.

In order to continue the process, the company must submit a major amendment, to include the additional information requested by the FDA, by April 29, 2015. This major amendment, which will have the same PMA number as the company’s initial filing, may extend the FDA review period up to 180 days after submission.

HIFU treatment is shown to be a minimally invasive and effective treatment option 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

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