News | Stent Grafts | July 16, 2018

Endologix Reports Positive One-Year Results From the Ovation LUCY Study

Women achieved similar outcomes to men in endovascular aortic repair with the Ovation Abdominal Stent Graft System

Endologix Reports Positive One-Year Results From the Ovation LUCY Study

July 16, 2018 — Endologix Inc. announced one-year results from the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) registry at the 2018 Society for Vascular Surgery (SVS) Annual Meeting, June 21-23 in Boston. The LUCY study is the first to prospectively evaluate endovascular aneurysm repair (EVAR) outcomes in women who have more complex aortic anatomy and, subsequently, have worse reported outcomes than men undergoing EVAR.1 The results of the LUCY one-year data expand on the 30-day results presented last year, showing that at least 28 percent more women are eligible for minimally-invasive EVAR when using the Ovation Abdominal Stent Graft System than when using other EVAR systems.2

The LUCY study is a prospective, consecutively enrolling, non-randomized, multi-center, post-market registry evaluating the Ovation System for the endovascular treatment of abdominal aortic aneurysms (AAA) in women.3 The study enrolled a total of 225 patients, including 76 females in the treatment group and 149 males in the control group, at 39 sites in the U.S. The primary endpoint of the study was the 30-day major adverse event (MAE) rate, and secondary endpoints included serious and non-serious adverse events through one year.

The one-year LUCY data showed that, despite having more complex anatomy at the time of the index procedure than men, women had similar outcomes to men following treatment with the ultra-low profile (14F) Ovation device:

  • Freedom from AAA-related morality: 100 percent in women vs 98.6 percent in men;
  • Freedom from reintervention for Type 1a endoleak: 98.6 percent in women vs 97.9 percent in men;
  • Freedom from rupture: 100 percent in both women and men;
  • Freedom from conversion: 100 percent in both women and men; and
  • Freedom from all device-related reintervention: 97.2 percent in both women and men

Jennifer Ash, M.D., Christie Clinic Vein and Vascular Center and assistant clinical professor of surgery, University of Illinois College of Medicine in Champaign, said, “Women have specific anatomical challenges in iliac access and proximal aortic neck morphology and have historically had worse outcomes from EVAR than men. The results of the LUCY study suggest that the unique features of the low-profile Ovation system may overcome these challenges and achieve similar outcomes in men and women.”4,5

For more information: www.vascular.org

References

1. Pinar Ulug, PhD, et al. www.thelancet.com Published online April 25, 2017 Sweet, M, M.D., et al. J Vasc Surg 2011; 54:931-7.

2. Analysis based on available data from the LUCY Study female cohort (72 out of 76) and on comparisons with grafts ranging from 18F – 21F OD manufactured by global market leaders. Data extracted on May 1, 2017. The Ovation Abdominal Stent Graft System has not been studied in a head-to-head clinical study against other EVAR devices for outcomes in women.

3. Two percent of patients had vascular characteristics beyond the FDA-approved anatomic IFU. Safety and effectiveness, of Ovation when used off-IFU, have not been established.

4. Mehta M, Byrne WJ, Robinson H, et al. “Women derive less benefit from elective endovascular aneurysm repair than men.” J Vasc Surg. Apr 2012;55(4):906-913.

5. Lowry, D, et al. “Sex-related Outcome Inequalities in Endovascular Aneurysm Repair.” Eur J Vasc Endovasc Surg (2016) 1-8.

Related Content

News | Cardiovascular Clinical Studies

June 24, 2022 — Henry Ford Health was part of a multi-institutional heart failure study that was launched and executed ...

Home June 24, 2022
Home
News | Cardiovascular Clinical Studies

June 21, 2022 — Renibus Therapeutics (“Renibus”), a clinical-stage biotech company focusing on the prevention and ...

Home June 21, 2022
Home
News | Cardiovascular Clinical Studies

June 13, 2022 — Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that ...

Home June 13, 2022
Home
News | Cardiovascular Clinical Studies

June 1, 2022 — Biofourmis, a Boston-based global leader in virtual care and digital medicine, announced that its ...

Home June 01, 2022
Home
News | Cardiovascular Clinical Studies

May 31, 2022 — Findings from the XARELTO (rivaroxaban) Phase 3 COMPASS Long-Term Open Label Extension (LTOLE) study and ...

Home May 31, 2022
Home
News | Cardiovascular Clinical Studies

May 26, 2022 — For more than 20 years, scientists have known that people with hypertension, diabetes, high cholesterol ...

Home May 26, 2022
Home
News | Cardiovascular Clinical Studies

May 25, 2022 — Researchers from the group of Eva van Rooij used advanced sequencing technology to better understand the ...

Home May 25, 2022
Home
News | Cardiovascular Clinical Studies

May 23, 2022 — A specific protein in blood vessel cells plays a major role in the development of vascular and ...

Home May 23, 2022
Home
News | Cardiovascular Clinical Studies

May 20, 2022 — Results from a real-world study investigating safety and effectiveness of clopidogrel versus aspirin ...

Home May 20, 2022
Home
News | Cardiovascular Clinical Studies

May 11, 2022 — Hypertrophic cardiomyopathy is a heart disease that leads to a stressed, swollen heart muscle. Due to a ...

Home May 11, 2022
Home
Subscribe Now