Global ENCORE Analysis Evaluates Polymer EVAR Using Endologix's Ovation Systems

March 20, 2018—Endologix, Inc. announced the first results from ENCORE, a pooled, global analysis of several prospective clinical trials and registries studying polymer endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) using the company's Ovation abdominal stent graft systems.

The retrospective ENCORE analysis encompassed six prospectively enrolled clinical trials and registries of the Ovation system that were composed of 1,296 patients at 160 centers in the United States, Europe, and Latin America.

In this contemporary analysis, outcome variables were standardized across each study. The findings are a mix of real-world registry and controlled data, and all endpoints are presented using Kaplan-Meier survival estimates. Median follow-up across all studies was 883 days (range, 30 days to 5 years).

At 5 years, the ENCORE analysis included the following results for Ovation based on the available data: 99.1% freedom from AAA-related mortality, 99% freedom from reintervention for type Ia endoleak, 99.7% freedom from rupture, 99.2% freedom from conversion, and 96.4% freedom from all device-related reintervention.

The company stated that the objective of ENCORE was to conduct a rigorous, global evaluation of the available polymer EVAR clinical data, which includes nearly 1,300 patients, as well as to share the findings with physicians worldwide, which it will continue to do.