Michael Barbella, Managing Editor01.12.23
Endologix LLC is touting encouraging five-year results from its LEOPARD randomized controlled trial.
LEOPARD was a prospective multi-center study that directly compared the anatomically fixated AFX 2 Endovascular AAA System and the predecessor AFX device, to commercially available endografts with proximal fixation. The trial enrolled 455 patients across 56 U.S. 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.
“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, M.D., the study’s principal investigator and chief medical officer at The Vascular Care Group/Mangrove Management Partners.
According to results:
Endologix LLC is a California-based, global medical device company providing therapies for interventional vascular disease treatment. Endologix’s therapeutic portfolio includes products in various stages of development 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 Oct. 1, 2020, Endologix became a private company, wholly owned by Deerfield Management, an investment management firm. In April 2021, Endologix acquired PQ Bypass Inc., a privately held medical technology, adding the DETOUR System and TORUS Stent Graft to its product pipeline. The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body and is an investigational device, limited by U.S. law to investigational use. The company has offices and manufacturing sites in Irvine and Santa Rosa, Calif.
Reference
1 Use 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
LEOPARD was a prospective multi-center study that directly compared the anatomically fixated AFX 2 Endovascular AAA System and the predecessor AFX device, to commercially available endografts with proximal fixation. The trial enrolled 455 patients across 56 U.S. 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.
“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, M.D., the study’s principal investigator and chief medical officer at The Vascular Care Group/Mangrove Management Partners.
According to results:
- Freedom from ARC at five years was 63.8% in AFX/ AFX2 device cohort and 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 five 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 five years for the AFX2 cohort than the 31.6% rate seen with 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.
Endologix LLC is a California-based, global medical device company providing therapies for interventional vascular disease treatment. Endologix’s therapeutic portfolio includes products in various stages of development 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 Oct. 1, 2020, Endologix became a private company, wholly owned by Deerfield Management, an investment management firm. In April 2021, Endologix acquired PQ Bypass Inc., a privately held medical technology, adding the DETOUR System and TORUS Stent Graft to its product pipeline. The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body and is an investigational device, limited by U.S. law to investigational use. The company has offices and manufacturing sites in Irvine and Santa Rosa, Calif.
Reference
1 Use 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