Endologix (ELGX) Announces FDA Request for Follow-up Data on EVAS-FORWARD IDE Study of Nellix EVAS System
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Endologix, Inc. (Nasdaq: ELGX) announced that the U.S Food and Drug Administration (FDA) has requested the Company provide 2-year patient follow-up data from the EVAS-FORWARD IDE Study of the Nellix EndoVascular Aneurysm Sealing System (Nellix EVAS System). The Company expects these data to be available and submitted to the FDA in the second quarter of 2017, followed by a possible FDA advisory panel meeting by the end of 2017, and potential FDA PMA approval of Nellix in the second quarter of 2018.
John McDermott, Chief Executive Officer of Endologix, said, “We’re disappointed by these requirements and the resulting delay, but encouraged by the 2-year clinical outcomes we have seen so far with Nellix under our newly revised instructions for use. We remain committed to EVAS with Nellix and have demonstrated outstanding clinical results in selected patients with both traditional and complex AAA anatomies. We look forward to providing this important new technology to physicians and patients in the U.S. and other markets as soon as possible.”
Nellix is an investigational device in the United States.
The company will discuss the updated Nellix PMA process as part of its business overview at its 2016 Investor Meeting, which is scheduled for Thursday, November 17, 2016. The Investor Meeting will be held on November 17, 2016 from 4:30 to 7:00 pm ET at the Sheraton New York Times Square Hotel in New York City. The event will include a Company update along with presentations from prominent physicians on the Company's product portfolio and a question and answer session with the physicians and Endologix management.
|Event:||Endologix Investor Meeting|
|Date:||November 17, 2016|
|Time:||4:30 to 7:00 pm ET (registration and refreshments begin at 4:30 pm ET; formal presentation begins at 5:00 pm ET)|
|Location:||Sheraton New York Times Square Hotel|
|811 7th Ave 53rd Street, New York, NY|
A live audio webcast of the investor meeting will be available by visiting the investor relations section of Endologix's website at www.endologix.com. Participants are encouraged to log on a few minutes prior to 5:00 pm ET in order to download any applicable audio software. A replay of the presentation will be available within 24 hours and will be available for approximately one year.
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