Business Wire08.31.17
Endologix Inc., a developer and marketer of treatments for aortic disorders, announced positive interim results from the LEOPARD (Looking at Evar Outcomes by Primary Analysis of Randomized Data) clinical study. LEOPARD is the first and only head-to-head, prospective, multi-center, randomized clinical study comparing currently available endovascular abdominal aortic stent grafts. LEOPARD directly compares the Endologix AFX and AFX2 endografts to other commercially available bifurcated aortic endografts.
LEOPARD was initiated in 2015 and has since randomized 458 patients. The primary endpoint in the study is freedom from Aneurysm Related Complications (ARC), such as aneurysm rupture, conversion to open repair, endoleaks, migration, aneurysm enlargement and secondary interventions. Based upon the patients that have completed their one-year follow-up, freedom from ARC with AFX/AFX2 is 84.7 percent, compared to 82 percent with the other devices. These preliminary results demonstrate similar outcomes between the endografts under investigation, but there is a trend towards better performance for AFX/AFX2, which is the only device that preserves the patient’s aortic bifurcation. Based upon the anticipated number of additional patients required to prove superiority, Endologix plans to stop further randomization in the LEOPARD study and continue to follow enrolled patients for the planned five years.
“The results from this analysis are very encouraging. In particular, we are pleased with the trend towards lower rates of endoleaks, limb occlusions and secondary interventions with AFX/AFX2, along with the absence of Type 3 endoleaks,” commented John McDermott, Endologix’s CEO. “We’d like to thank our investigators for participating in this important clinical study and look forward to presenting the final one-year results next year after all patients have completed their follow-up.”
Endologix Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Irvine, Calif.-based company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80 percent, making it a leading cause of death in the United States.
LEOPARD was initiated in 2015 and has since randomized 458 patients. The primary endpoint in the study is freedom from Aneurysm Related Complications (ARC), such as aneurysm rupture, conversion to open repair, endoleaks, migration, aneurysm enlargement and secondary interventions. Based upon the patients that have completed their one-year follow-up, freedom from ARC with AFX/AFX2 is 84.7 percent, compared to 82 percent with the other devices. These preliminary results demonstrate similar outcomes between the endografts under investigation, but there is a trend towards better performance for AFX/AFX2, which is the only device that preserves the patient’s aortic bifurcation. Based upon the anticipated number of additional patients required to prove superiority, Endologix plans to stop further randomization in the LEOPARD study and continue to follow enrolled patients for the planned five years.
“The results from this analysis are very encouraging. In particular, we are pleased with the trend towards lower rates of endoleaks, limb occlusions and secondary interventions with AFX/AFX2, along with the absence of Type 3 endoleaks,” commented John McDermott, Endologix’s CEO. “We’d like to thank our investigators for participating in this important clinical study and look forward to presenting the final one-year results next year after all patients have completed their follow-up.”
Endologix Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Irvine, Calif.-based company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80 percent, making it a leading cause of death in the United States.
