But the federal watchdog agency’s Center for Devices & Radiological Health left the door open for another run at pre-market approval, the French medical device maker said, recommending a narrower indication for Ablatherm.
An FDA advisory panel in July recommended against approval for Ablatherm, a computer-controlled high-intensity focused ultrasound device that delivers treatment from an endorectal probe under ultrasound visualization and is intended to ablate the entire prostate gland.
Edap said the FDA not-approvable letter "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 trial], to support approval for the modified indication," according to a press release. "Although additional data and analyses will be necessary to address FDA’s requests, the letter did not require a new U.S. IDE study."
Edap said it has until April 29, 2015, to submit an updated PMA application, which would then trigger a 180-day review period at the FDA.
"This response from the FDA reflects the extensive and ongoing discussions between our team and agency staff since the advisory panel meeting in July. We appreciate the FDA providing us with constructive and comprehensive recommendations, and believe this may be a potential opportunity to advance through the approval path for our PMA," CEO Marc Oczachowski said in prepared remarks.
Edap said it will elaborate on the FDA not-approvable letter when it releases its 3rd-quarter results Nov. 20.