Endologix, Inc. (Nasdaq: ELGX) today announced the results of a study, which was presented by Marc Schermerhorn, M.D., Chief of Vascular Surgery of Beth Israel Deaconess Medical Center, on the podium at the Late-Breaking Aortic Trials Session during the Charing Cross 40th International Symposium. This retrospective, propensity-weighted study compares long-term survival for the Nellix® EndoVascular Aneurysm Sealing (EVAS) System with traditional endovascular aneurysm repair (EVAR). The study demonstrated significantly higher three-year survival for EVAS patients. Those patients with larger aneurysms treated with EVAS had half the mortality at three years as compared to those treated with traditional EVAR systems.
The retrospective study included 333 EVAS patients from the original Nellix U.S. Investigational Device Exemption (IDE) Trial and 15,431 EVAR patients from the Society for Vascular Surgery Vascular Quality Initiative (VQI), all of whom were treated between 2014 and 2016. The patients were propensity weighted for abdominal aortic aneurysm (AAA) size, patient demographics, and cardiovascular risk factors. The primary outcome was overall survival, with a secondary analysis of overall survival stratified by aneurysm size.
EVAS patients experienced higher three-year survival than EVAR patients (93 percent versus 88 percent, P = .02), which corresponded to a 41-percent lower risk of mortality with EVAS. In patients with larger aneurysms (greater than 5.5cm in diameter), patients treated with EVAS had a mortality rate 50 percent lower than patients treated with EVAR (P = .02).
Dr. Schermerhorn said, “The study sought to examine two different therapies for treating AAA and compare the associated mortality. Traditional EVAR excludes the aneurysm sac and has been associated with thrombus generation, sac remodeling, inflammation, and endoleaks, while EVAS excludes and seals the entire aneurysm sac.”
He continued, “The survival difference seen in this study supports the continued development of EVAS therapy and demonstrates its potential to improve patient outcomes. The results also justify further study to compare cardiovascular events between the two therapies in order to understand the mechanism behind the events.”
“In earlier Nellix EVAS studies, all-cause and cardiovascular mortality were lower than expected, and this propensity-weighted analysis is the first contemporary comparison of the data. We are committed to the innovative aneurysm sealing approach and look forward to completing our EVAS2 confirmatory trial, which is required in support of FDA approval,” commented Endologix’s Chief Medical Officer, Matt Thompson, M.D.
Since completion of the original 333-patient Nellix IDE trial, the Instructions for Use (IFU) have been refined to improve aneurysm-related outcomes. In March 2018, Endologix initiated the EVAS2 confirmatory IDE trial to evaluate the safety and effectiveness of the refined IFU together with the next generation Nellix EVAS System.
The data that serve as the basis for this analysis include patients under the original Nellix IFU criteria, and the analysis has not been reviewed by the FDA. The Nellix EndoVascular Aneurysm Sealing System is an investigational device in the U.S. and is limited by federal law to investigational use only. The Nellix EndoVascular Aneurysm Sealing System and associated components are not available in all countries or regions. In countries and regions in which it is approved, the Nellix EndoVascular Aneurysm Sealing System is approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography. Prior to use, refer to the IFU for complete and specific indications, contraindications, all warnings and precautions.