Endovascular Aortic disorder specialist, Endologix, Inc., tells us its 2 year IDE study into the Nellix® EVAS system, has yielded promising results.
Background
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. These include endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA) such as the Nellix® Endovascular Aneurysm Sealing System (“Nellix EVAS System”).
Endologix, Inc., a developer and marketer of innovative treatments for aortic disorders, today announced the presentation of two-year clinical data from the Company’s Nellix® EVAS FORWARD IDE trial that prospectively enrolled patients with abdominal aortic aneurysms (“AAA”) who were treated with the system.
The Study’s Principal Investigator, Dr. Jeffrey Carpenter, MD, Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in New Jersey, presented the results at the Society of Vascular Surgery 2017 Vascular Annual Meeting.
Key highlights from the two-year data included:
• Freedom from all endoleaks (94%), rupture (97%), all-cause mortality (97%), and cardiovascular mortality (99%), among all patients.
• Highest freedom of type II endoleaks, of 97%, ever reported at two years, among all patients.
• When applying the refined IFUs for Nellix, patients at the two-year follow-up demonstrated a highly encouraging 96% freedom from Type Ia endoleak, migration, and sac growth.
Investigator comments
Dr. Jeffrey Carpenter, MD, Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in New Jersey, said, “The overall two-year results for EVAS with Nellix are very encouraging. In particular, the refined IFU appears to offer excellent patient outcomes, and we look forward to validating these results in the upcoming prospective confirmatory study.”
Company comments
John McDermott, Chief Executive Officer of Endologix, Inc., commented, “We would like to thank Dr. Carpenter and all the investigators for their participation in the IDE study, as well as their important contributions to the learning and evolution of EVAS. We have identified an AAA patient population that will significantly benefit from the Nellix device, and we look forward to expanding applicability with ChEVAS, and our next generation EVAS platform, in the future.”
