Endologix Begins Study of ALTO Abdominal Stent Graft System

Endologix LLC has enrolled the first patient in the JAGUAR study to compare outcomes for the company’s ALTO Abdominal Stent Graft System to other commercially available endovascular aneurysm repair (EVAR) devices for the treatment of abdominal aortic aneurysm (AAA).
 
JAGUAR (ObJective Analysis to GaUge EVAR Outcomes Through Randomization in a Real-world Population) is a prospective, randomized, multi-center study that will enroll approximately 450 patients at up to 60 sites worldwide. The study is designed for at least 300 patients to be randomly allocated to the ALTO cohort and 150 to the comparator group. All patients will be followed through five years. Results from the study will be independently adjudicated by a third party.
 
“The availability of compelling clinical evidence for EVAR devices is crucial for making informed treatment decisions and improving patient outcomes,” said Jean Panneton, M.D., vascular surgeon with Sentara Vascular Specialists who treated the patient at Sentara Norfolk General Hospital.
 
JAGUAR has two primary endpoints: a clinical endpoint and an imaging endpoint. The clinical endpoint is a composite of aneurysm-related complications and consists of freedom from device-related interventions, conversion to open surgery, Type | and III endoleaks, clinically significant device migration, aneurysm enlargement, occlusion, aneurysm rupture and aneurysm-related death. The imaging endpoint is related to proximal neck dilation over time and allows for early insight into mechanisms of graft failure.
 
“Endologix is committed to investing in clinical evidence,” said Prof. Matt Thompson, chief medical officer of Endologix. “JAGUAR joins our LEOPARD study as the only two randomized clinical trials designed to evaluate comparative endograft performance. We believe that this real-world study will provide valuable insights to inform EVAR treatment decisions and improve patient outcomes.”
 
Featuring a unique, patented, sealing technology, the ALTO Abdominal Stent Graft System is the latest generation of therapies for AAA patients. ALTO utilizes a low-profile delivery system and, unlike standard EVAR devices, features an exclusive Adaptive Sealing Technology that molds in-situ to the patient’s specific aortic neck anatomy.
 
Endologix LLC is a global medical device company dedicated to improving patients’ lives by providing therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes various 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. Excellent clinical outcomes will be achieved through meticulous attention to product design, manufacturing, and training, all backed by clinical evidence. Endologix’s abdominal aortic aneurysm (AAA) products are built on one of two platforms: Traditional minimally invasive endovascular aneurysm repair (EVAR) and endovascular aneurysm sealing (EVAS), which is investigational product. Endologix’s current commercial EVAR products include the AFX 2 device and the ALTO Abdominal Stent Graft System. Endologix became a private company, wholly owned by Deerfield Management on Oct. 1, 2020. The company has offices and manufacturing sites in Irvine and Santa Rosa, Calif.