Aortic disorder specialist, Endologix, Inc., says a first patient has been treated in the EVAS2 IDE Confirmatory Clinical Study of the investigational Nellix® EndoVascular Aneurysm Sealing (EVAS) System.
Followed on our pages for some time now, it being four years since the Nellix System gained IDE go-ahead. Nellix is an endovascular abdominal aortic aneurysm (AAA) therapy designed to seal the entire aneurysm. Nellix is the first and only EVAS product developed as an alternative treatment approach to traditional EVAR devices. It is CE Marked and commercially available in many markets, including the EU.
EVAS2 is an IDE-approved confirmatory clinical study, which is designed to evaluate the safety and effectiveness of the second-generation Nellix System and the refined Indications for Use (IFU). The study is approved to enroll up to 90 primary patients at 28 U.S. centers, with one-year follow-up data required for the Pre-Market Approval (PMA) application.
The first patient was treated by Sajjad M. Hussain, M.D., Chief of the Department of Vascular Surgery at St. Vincent Health and St. Vincent Heart Center of Indiana.
“We are excited to be part of this important trial studying the concept of total aneurysm sealing,” said Jeffrey Carpenter, M.D., Professor and Chairman of Surgery for Cooper Medical School, Chief of Surgery for Cooper Health System in New Jersey, and principal investigator for the EVAS2 study. “The second-generation Nellix device, together with the refined IFU and our clinical learnings over the past few years, has the potential to improve outcomes for patients with abdominal aortic aneurysms.”
John McDermott, Chief Executive Officer of Endologix, Inc. said, “We would like to congratulate Dr. Hussain and the clinical study team at St. Vincent Hospital for completing the first EVAS2 procedure in the confirmatory study. We look forward to collaborating with all of our investigators to achieve excellent clinical outcomes for patients and to complete enrollment in the study. Based on anticipated enrollment, follow-up, and typical regulatory review timelines, we continue to estimate a decision on our PMA by the end of 2020.”
Source: Endologix, Inc.