Endologix Inc. 02.23.17
Endologix Inc., developer and marketer of treatments for aortic disorders, has completed patient enrollment in the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) study, a multi-center post-market registry designed to explore the clinical benefits associated with endovascular aneurysm repair (EVAR) using the Ovation Abdominal Stent Graft Platform in female patients with abdominal aortic aneurysms (AAA), as compared to males. It is the first prospective study evaluating EVAR in females, a population that has historically been underrepresented in EVAR clinical trials.
The LUCY study enrolled a total of 225 patients, including 75 females in the treatment group and 150 males in the control group, at 39 sites in the United States. The primary endpoint of the study is the 30-day Major Adverse Event (MAE) rate. The 30-day results from the LUCY study are anticipated to be presented at a medical meeting in the summer of 2017. The LUCY Study is led by an advisory board whose members include: Chairperson Jennifer Ash, M.D., of the Christie Clinic Vein and Vascular Center and assistant clinical professor of surgery at the University of Illinois College of Medicine in Urbana-Champaign; and Members Venita Chandra, M.D., clinical assistant professor of surgery-vascular surgery at the Stanford School of Medicine; Monica Hunter, M.D., of the Birmingham Heart Clinic at St. Vincent’s in Birmingham, Ala.; Eva Rzucidlo, M.D., of McLeod Vascular and associate professor of surgery at the Geisel School of Medicine in Dartmouth; and Ageliki Vouyouka, M.D., associate professor of surgery and radiology at Mount Sinai Hospital.
“Women have historically been underrepresented in EVAR clinical trials," Chandra said. "One factor precluding women has been that traditional EVAR devices have been unable to accommodate the anatomic variances found in women, such as smaller access vessels and more challenging proximal aortic necks, compared to their male counterparts. The LUCY study is the first prospective study evaluating EVAR in a female population and it will make an important contribution to understanding the management and outcomes of women and other patients with similar anatomy.”
“Retrospective analyses of women treated with traditional EVAR devices have consistently shown that women tend to have greater morbidity and mortality from EVAR intervention. Our preliminary analysis of the patients who have completed their 30-day follow-up visits suggest that women in the LUCY Study derived similarly favorable benefits from the Ovation Platform’s ultra-low profile delivery system and unique proximal sealing ring as compared to their male counterparts," Ash added. "We look forward to completing the patient follow-up and presenting the analysis at an upcoming meeting.”
“The completion of enrollment in the LUCY study is another milestone in our efforts to continue building the clinical evidence in support of our portfolio of AAA products. It highlights our commitment to developing technologies that can improve clinical outcomes for AAA patients, including populations such as women that have historically been underserved with existing technologies," said John McDermott, CEO of Endologix. "I would like to thank the clinical investigators and trial sites for their participation and support of this important clinical study.”
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, 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.
The LUCY study enrolled a total of 225 patients, including 75 females in the treatment group and 150 males in the control group, at 39 sites in the United States. The primary endpoint of the study is the 30-day Major Adverse Event (MAE) rate. The 30-day results from the LUCY study are anticipated to be presented at a medical meeting in the summer of 2017. The LUCY Study is led by an advisory board whose members include: Chairperson Jennifer Ash, M.D., of the Christie Clinic Vein and Vascular Center and assistant clinical professor of surgery at the University of Illinois College of Medicine in Urbana-Champaign; and Members Venita Chandra, M.D., clinical assistant professor of surgery-vascular surgery at the Stanford School of Medicine; Monica Hunter, M.D., of the Birmingham Heart Clinic at St. Vincent’s in Birmingham, Ala.; Eva Rzucidlo, M.D., of McLeod Vascular and associate professor of surgery at the Geisel School of Medicine in Dartmouth; and Ageliki Vouyouka, M.D., associate professor of surgery and radiology at Mount Sinai Hospital.
“Women have historically been underrepresented in EVAR clinical trials," Chandra said. "One factor precluding women has been that traditional EVAR devices have been unable to accommodate the anatomic variances found in women, such as smaller access vessels and more challenging proximal aortic necks, compared to their male counterparts. The LUCY study is the first prospective study evaluating EVAR in a female population and it will make an important contribution to understanding the management and outcomes of women and other patients with similar anatomy.”
“Retrospective analyses of women treated with traditional EVAR devices have consistently shown that women tend to have greater morbidity and mortality from EVAR intervention. Our preliminary analysis of the patients who have completed their 30-day follow-up visits suggest that women in the LUCY Study derived similarly favorable benefits from the Ovation Platform’s ultra-low profile delivery system and unique proximal sealing ring as compared to their male counterparts," Ash added. "We look forward to completing the patient follow-up and presenting the analysis at an upcoming meeting.”
“The completion of enrollment in the LUCY study is another milestone in our efforts to continue building the clinical evidence in support of our portfolio of AAA products. It highlights our commitment to developing technologies that can improve clinical outcomes for AAA patients, including populations such as women that have historically been underserved with existing technologies," said John McDermott, CEO of Endologix. "I would like to thank the clinical investigators and trial sites for their participation and support of this important clinical study.”
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, 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.
