Endologix (ELGX) Announces Ovation LIFE Study Met Primary Endpoint in AAA

September 20, 2016 12:12 PM EDT

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Endologix, Inc. (Nasdaq: ELGX) announced positive clinical data from the Ovation LIFE (Least Invasive Fast-Track EVAR) study. Zvonimir Krajcer, MD, FACC, Co-Director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, TX, and one of the co-national principal investigators in the LIFE study, presented the results in a late breaking session at Vascular InterVentional Advances (VIVA), which is being held September 18-22 in Las Vegas, NV.

The LIFE study, which prospectively enrolled 250 patients at 34 centers in the United States, is designed to evaluate the Ovation® Abdominal Stent Graft platform when used in the treatment of patients with abdominal aortic aneurysms ("AAA"). The LIFE study is the first of its kind using a Fast-Track EVAR protocol, which includes bi-lateral percutaneous access enabled by Ovation’s ultra-low profile (14F) design, avoidance of general anesthesia and intensive care unit (“ICU”) admission post procedure, and next-day discharge.

Data from the LIFE study demonstrated that Ovation met the study primary endpoint for major adverse events at 30 days. Key highlights of the presentation, with outcomes covering one-month follow-up, include:

  • Low major adverse event (MAE) rate of 0.4%
  • No ruptures, conversion, or secondary interventions
  • 99% and 100% freedom from type I and type III endoleak
  • Fast-Track completed in 216 (87%) patients, with positive results compared to non-Fast-Track patients:
    • Procedure time of 84 minutes vs. 110 minutes
    • General anesthesia use 0% vs. 18%
    • ICU stay 0% vs. 32%
    • Mean hospital stay 1.2 vs. 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.

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.”

John McDermott, Chairman and Chief Executive Officer of Endologix, said, “We are extremely pleased with the positive results from the LIFE study. The outstanding clinical outcomes combined with the significant cost savings provides evidence that Ovation used in conjunction with the Fast-Track protocol is better for patients, hospitals and payors. We look forward to building awareness of these results and working with clinicians and hospitals to adopt Ovation and the Fast-Track protocol for their AAA patients.”

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