Endologix Alto EVAR System to Be Evaluated in Randomized JAGUAR Study

September 29, 2021—Endologix LLC announced that the first patient has been enrolled in the JAGUAR study. The study will 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 aneurysms in a real-world patient population.

According to the company, JAGUAR is a prospective, randomized, multicenter 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 5 years. Results from the study will be independently adjudicated by a third party.

JAGUAR has two primary endpoints:

• The clinical endpoint is a composite of aneurysm-related complications, which include device-related interventions, conversion to open surgery, type I 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.

Jean Panneton, MD, a vascular surgeon with Sentara Vascular Specialists, treated the first patient in JAGUAR at Sentara Norfolk General Hospital in Norfolk, Virginia.

“The availability of compelling clinical evidence for EVAR devices is crucial for making informed treatment decisions and improving patient outcomes,” commented Dr. Panneton in the company’s press release.

Endologix noted that Alto, which is the company’s latest-generation abdominal stent graft system, utilizes a low-profile delivery system and features the company’s adaptive sealing technology that molds in-situ to the patient’s specific aortic neck anatomy. In July 2020, the company announced the United States launch of the device in July 2020 after receiving FDA approval in March 2020. The company subsequently received CE Mark approval and introduced the device in Europe and other international markets.