Endologix's Ventana System Studied for Treatment of Juxtarenal and Pararenal AAAs

January 31, 2012—Endologix, Inc. (Irvine, CA) announced the beginning of enrollment in the company's clinical trial to evaluate the Ventana fenestrated stent graft system for the endovascular repair of juxtarenal and pararenal abdominal aortic aneurysms (AAAs) in the United States. Matthew Eagleton, MD, performed the trial's first procedure, which was proctored by National Principal Investigator Daniel G. Clair, MD.

Dr. Eagleton commented, “We are excited to be the first investigational site to enroll a patient in the Ventana trial using this innovative new stent graft technology. This trial will offer participation to patients with abdominal aortic aneurysms that extend near or involve the renal arteries—patients who are not treatable with any of the approved endovascular aneurysm repair devices.”

He continued, “The Ventana stent graft is designed with movable fenestrations for in vivo adjustment to match the specific location of a patient's renal arteries along the aorta, which is essential to addressing the anatomical challenges of these aneurysms. The Ventana system performed well, and postprocedure imaging showed that the stent graft completely sealed the aneurysm and maintained blood flow to the kidneys.”

Dr. Clair added, “The Ventana system is the first integrated, off-the-shelf endovascular stent graft device system in a multicenter, prospective clinical trial for patients with juxtarenal and pararenal AAAs. The experience with our first Ventana patient in the United States highlighted the fenestration movement, ease of use, and aneurysm sealing attributes of the device and, more importantly, provided a minimally invasive treatment option for a patient that previously could not be offered an approved endovascular option. We look forward to begin treating patients at other clinical trial sites in the near future.”

According to Endologix, the multicenter, prospective, single-arm Ventana clinical trial was approved by the US Food and Drug Administration under an investigational device exemption to enroll 122 patients at up to 25 clinical sites in the United States. The trial is intended to support a future premarket approval application to the US Food and Drug Administration to provide reasonable assurances of safety and effectiveness for the Ventana system for the endovascular repair of juxtarenal and pararenal aneurysms in selected patients. The trial's primary endpoints will evaluate safety (major adverse events) at 30 days and effectiveness (treatment success) at 1 year, with continuing follow-up to 5 years.