Endologix (NSDQ:ELGX) said today that it won an investigational device exemption from the FDA for a clinical trial of its star-crossed Nellix stent graft, after the federal safety watchdog earlier this year asked for two-year follow-up data on the device.
CEO John McDermott said the IDE approval sets the stage for a possible pre-market approval in 2020. The The 90-patient EVAS2 study is designed to evaluate the refined indications for use for the second-generation Nellix device through one year of follow up, according to Irvine, Calif.-based Endologix.
“We are pleased to receive IDE approval from the FDA to begin this confirmatory study and look forward to collaborating with the investigators to achieve the goal of commencing enrollment by the end of this year. Based on the anticipated enrollment timeline, one-year follow up period, and regulatory review process, we continue to estimate PMA approval in 2020,” McDermott said in prepared remarks.
In May ELGX shares plunged more than 30% after Endologix revealed that meetings with the FDA and “further internal analysis” led it to decide to launch a “confirmatory” trial for Nellix, which was initially delayed in November 2016 when the federal safety watchdog asked for two-year follow-up data from the EVAS-Forward investigational device exemption study.
Endologix won CE Mark approval in the European Union for Nellix back in 2012, less than 2 years after acquiring its namesake company in an all-stock transaction.
The news sent ELGX shares up 5.1% to $5.99 apiece today in pre-market trading.