Endologix has met with the US Food and Drug Administration (FDA) regarding its Nellix endovascular aneurysm sealing system (EVAS System).
Based upon that meeting and further internal analysis, the company has determined that it will seek US approval of the Nellix EVAS system by conducting a confirmatory clinical study with the previously updated instructions for use (IFU) and the Gen2 device design, which is currently sold in Europe and other international markets. The company will collaborate with the FDA over the coming months on the confirmatory clinical study protocol and anticipates beginning patient enrollment in the fourth quarter of this year with pre-market approval estimated to occur in 2020.
John McDermott, chief executive officer of Endologix, commented, “While the timeline has shifted from our projections, we appreciate the FDA’s collaboration as Nellix EVAS proceeds in the regulatory process. We have evidence that our previously updated Nellix IFU provides excellent patient outcomes and look forward to starting the confirmatory clinical study with our Gen2 device. We appreciate the support of our physicians worldwide and their continued collaboration in developing new technologies and conducting clinical studies to provide the best outcomes for patients with abdominal aortic aneurysms.”