Endologix Reports Five-Year Data of the LEOPARD Trial at 2022 Vascular InterVentional Advances (VIVA) Conference

The LEOPARD (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) trial is the first randomized controlled trial (RCT) comparing the outcomes of endovascular aneurysm repair (EVAR) using commercially available devices in a real-world population.

IRVINE, Calif. November 3, 2022—Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives by providing disruptive therapies for the interventional treatment of vascular disease, announced the five-year results from the LEOPARD randomized controlled trial. LEOPARD was a prospective multi-center trial designed to directly compare the anatomically fixated AFX®2 Endovascular AAA System and the predecessor AFX device, to commercially available endografts with proximal fixation.

The final five-year results from the LEOPARD study were presented during a Late-Breaking Clinical Trial Session at the 2022 VIVA Conference by the study’s principal investigator, Christopher J. Kwolek, MD, M.B.A., F.A.C.S., D.F.S.V.S., Chief Medical Officer, The Vascular Care Group / Mangrove Management Partners.

The LEOPARD trial enrolled 455 patients across 56 US Centers. 235 patients were included in the AFX/ AFX2 arm and 220 patients in the comparator arm. The primary endpoint was freedom from aneurysm-related complications (ARC), a composite endpoint consisting of perioperative death, aneurysm rupture, conversion to open surgical repair, post-operative endoleaks, endograft migration, aneurysm enlargement, endograft limb occlusion, and device- or aneurysm-related reintervention.

The results presented are listed below:

• Freedom from ARC at 5 years was:
  • 63.8% in AFX/ AFX2 device cohort
  • 55.5% in comparator endografts
• There was no significant difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and Type I and Type III endoleaks between the two cohorts
  • The Type III endoleak rate for the AFX/AFX2 device cohort was 1.5% at 5 years and was not statistically different from the comparator devices
  • The Type II endoleak rate reached a statistically significant lower rate at 21.2% at 5 years for the AFX2 cohort than the rate of 31.6% seen with the comparator devices
• The study’s results demonstrated no difference in aneurysm-related outcomes between patients randomized to the AFX and AFX2 device cohort or comparator endografts

“I am excited to present the results from the first-ever randomized controlled trial that compares outcomes between four different commercially available endovascular aneurysm repair (EVAR) devices. Randomized controlled trials represent the highest level of clinical evidence in medicine and it’s important that we continue to develop the evidence base for EVAR,” said Christopher J. Kwolek, MD, the study’s principal investigator.

“We are very proud to have performed the first RCT in this field and we continue to believe that the investment in industry leading clinical evidence is paramount to patient and physician needs. The 5-year results of the LEOPARD RCT continue to support the performance of our AFX2 System and its clinical utility in the treatment of patients with abdominal aortic aneurysms.” said Matt Thompson, MD, President and CEO of Endologix. ” Importantly, the results from the LEOPARD study, and the performance of AFX2 in comparison with other endografts, are concordant with a recent publication¹ using linked registry claims data, that was authored on behalf of the Society for Vascular Surgery’s, Patient Safety Organization.”

¹Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study. Goodney, Philip, et al. BMJ 2022;397:e071452

About Endologix

Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have clinically relevant unmet needs. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR products include the AFX®2 Endovascular AAA System and the ALTO® Abdominal Stent Graft System. On October 1, 2020, Endologix became a private company, wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. In April 2021, Endologix completed the acquisition of PQ Bypass, Inc., a privately held medical technology, adding the DETOUR System and TORUS Stent Graft to the Company’s product pipeline. The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body. The DETOUR System is an investigational device, limited by United States law to investigational use.

The company has offices and manufacturing sites in Irvine and Santa Rosa, California. To learn more about Endologix, please visit https://endologix.com/.

Contacts

Endologix LLC
Sandy Prietto
949-595-7240
sprietto@endologix.com