Endologix Reports 30-Day Data From LIFE Study

September 20, 2016—Endologix, Inc. announced that clinical data on the company’s Ovation abdominal stent graft platform for endovascular aneurysm repair (EVAR) were presented in a late-breaking trials session at VIVA 16, the Vascular InterVentional Advances conference held September 18–22 in Las Vegas, Nevada. The findings from the LIFE (Least Invasive Fast-Track EVAR) study were presented by National Coprincipal Investigator Zvonimir Krajcer, MD, who is Co-Director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, Texas.

According to Endologix, the LIFE study prospectively enrolled 250 patients at 34 centers in the United States to evaluate the Ovation platform when used in treating patients with abdominal aortic aneurysms (AAAs). Conducted under the US Food and Drug Administration’s Fast-Track EVAR protocol, the LIFE study includes bilateral percutaneous access enabled by Ovation's ultra-low-profile (14-F) design, avoidance of general anesthesia, intensive care unit (ICU) admission postprocedure, and next-day discharge. 

As summarized in the company’s announcement, the LIFE study met the primary endpoint for major adverse events at 30 days. One-month follow-up data included a 0.4% major adverse event rate; no ruptures, conversions, or secondary interventions; and 99% and 100% freedom from type I and type III endoleaks, respectively.

Additionally, Fast-Track follow-up was completed in 216 (87%) patients and showed positive results compared to non–Fast-Track patients: procedure time of 84 minutes versus 110 minutes, general anesthesia use of 0% versus 18%, ICU stay of 0% versus 32%, and mean hospital stay of 1.2 versus 1.9 days. 

A cost-utility analysis compared Fast-Track EVAR to an EVAR control group of 8,306 patients identified from a contemporary inpatient discharge database. Completion of the Fast-Track protocol was associated with over $21,000 in perioperative cost savings per patient relative to standard EVAR, largely driven by differences in hospital costs. Additionally, the 30-day EVAR hospital readmission rate in the LIFE study was 1.6%, compared to 8% from the American College of Surgeons National Surgical Quality Improvement Program. 

In the Endologix press release, Dr. Krajcer commented, “The LIFE study provides the first clinical evidence that a Fast-Track protocol for EVAR offers a safe and cost-effective option for eligible AAA patients. Patients in the Fast-Track treatment group did not require ICU admission and benefitted from shorter procedure times and hospital stays. This has the potential to drive significant perioperative cost-savings compared to standard EVAR for hospitals, while also improving clinical outcomes. The LIFE study provides compelling evidence to support the adoption of Ovation and the implementation of the Fast-Track protocol in EVAR centers.”