Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced 1-year results from the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) registry as reported on Saturday, June 23rd at the 2018 Society for Vascular Surgery Annual Meeting. 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 1-year data expand on the 30-day results presented last year, showing that at least 28% 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 including serious and non-serious adverse events through one year.
The 1-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% in women vs 98.6% in men
- Freedom from reintervention for Type 1a endoleak: 98.6% in women vs 97.9% in men
- Freedom from rupture: 100% in both women and men
- Freedom from conversion: 100% in both women and men
- Freedom from all device-related reintervention: 97.2% 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
John Onopchenko, Chief Executive Officer of Endologix, Inc., commented, “We are excited to have completed follow-up on the LUCY study and are pleased that the one-year results suggest, for the first time in a prospective study, that female AAA patients can be treated with EVAR as effectively as men, when using the Ovation System. LUCY’s evidence provides physicians with new information to confidently engage female patients with prospectively derived outcomes previously realized only by male patients.”
The LUCY study was led by an advisory board whose members include: Chairperson Jennifer Ash, M.D., Christie Clinic Vein and Vascular Center and Assistant Clinical Professor of Surgery, University of Illinois College of Medicine in Champaign; Venita Chandra, M.D., Clinical Assistant Professor of Surgery-Vascular Surgery, Stanford School of Medicine; Monica Hunter, M.D., Birmingham Heart Clinic at St. Vincent’s Birmingham; Eva Rzucidlo, M.D., McLeod Vascular and Associate Professor of Surgery, Geisel School of Medicine, Dartmouth; and Ageliki Vouyouka, M.D., Associate Professor of Surgery and Radiology, Mount Sinai Hospital.
|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.||2% 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.|