Endovascular Aneurysm Sealing With Nellix System Linked to Higher Survival Than Traditional Repair

Endologix Inc., a developer and marketer of treatments for aortic disorders, announced the results of a retrospective, propensity-weighted study that compared 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).
 
“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,” said Marc Schermerhorn, M.D., chief of Vascular Surgery at Beth Israel Deaconess Medical Center. “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.”
 
Endologix’s Chief Medical Officer, Matt Thompson, M.D., commented, “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.”
 
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 U.S. Food and Drug Administration. The Nellix EndoVascular Aneurysm Sealing System is an investigational device in the United States 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.
 
Endologix Inc. develops and manufactures minimally invasive treatments for aortic disorders. The company’s focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80 percent, making it a leading cause of death in the United States.