Endologix (ELGX) Announces Presentation of Nellix EVAS System Post-Market Study Data in AAA Patients
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Positive Two-Year Data from the Nellix® EVAS FORWARD Global Registry Presented at 2016 VEITH Symposium
November 17, 2016 9:30 AM ESTIRVINE, Calif., Nov. 17, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq: ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of two-year clinical data from the Company's EVAS FORWARD - Global Registry, a post-market study that prospectively enrolled patients with abdominal aortic aneurysms ("AAAs") who were treated with the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System"). Andrew Holden, MD, Associate Professor of Radiology at Auckland City Hospital (Auckland, New Zealand) and one of the principal investigators of the EVAS FORWARD - Global Registry, presented the results at the... More
Positive Five-Year Results from the Global Ovation® Pivotal Trial Presented at 2016 VEITH Symposium
November 16, 2016 10:00 AM ESTIRVINE, Calif., Nov. 16, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq: ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of positive 5-year safety and effectiveness clinical data from the global Ovation Pivotal Trial at the 2016 VEITH symposium. The results were presented by Manish Mehta, MD, MPH, Director, Vascular Health Partners of Community Care Physicians, PC and the U.S. principal investigator for the global Ovation Pivotal Trial.
The Ovation Pivotal Trial included a total of 161 patients, enrolled in Chile, Germany and USA from November 2009 to... More
Endologix Provides Update on Nellix PMA Process
November 16, 2016 9:00 AM ESTIRVINE, Calif., Nov. 16, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq: ELGX), developer and marketer of innovative treatments for aortic disorders, announced today 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... More
