Endologix announced on 24 January 2013 achievement of the CE mark of the Nellix EndoVascular Aneurysm Sealing System for the treatment of patients with abdominal aortic aneurysms. Nellix is the first available endovascular aneurysm sealing (EVAS) system. EVAS with Nellix is an advanced treatment strategy designed to simplify endovascular abdominal aortic aneurysm procedures, treat a broad range of patients, and provide enhanced clinical outcomes. The Nellix system is not approved in the United States for either investigational use or commercial sale.
This approval of the Nellix system includes a few enhancements intended to further optimise the device compared to the previous version, which received CE mark in October 2012. Endologix expects to begin a limited market introduction of the Nellix system in Europe during the second quarter 2013. The company will also initiate a post-market clinical study of the Nellix system beginning in the third quarter of 2013 in selected European centres of excellence.
John McDermott, president and chief executive officer, said, “We are very excited to receive CE mark for the Nellix System, which will allow Endologix to introduce the world’s first abdominal aortic aneurysm endovascular aneurysm sealing system, or EVAS, to physicians and patients in Europe. We believe Nellix has the potential to simplify abdominal aortic aneurysm procedures, treat a broad range of patients and improve clinical outcomes. The initial commercial activity for Nellix will begin in the second quarter 2013, with a focus on building the clinical experience in collaboration with thought-leading physicians. We will also begin a post-market clinical study, to gather additional data and patient follow-up to support gradual introductions in other markets. The physicians at the initial clinical sites will collect this data and also help us train other physicians as we gradually roll-out Nellix over the course of the year, with a broader launch anticipated in 2014.”
McDermott added, “We are well positioned in Europe with our AFX and Nellix systems and look forward to potential CE mark for our Ventana product in the near future. We have received strong interest in all of these products from the medical community and believe that Endologix offers physicians the most innovative range of products to treat their abdominal aortic aneurysm patients. We look forward to providing training and clinical support for these and other new technologies in 2013 and the years ahead.”