March 30, 2017
Endologix's ELEVATE IDE Clinical Trial Begins Patient Enrollment
March 31, 2017—Endologix, Inc. has announced that the company’s Expanding Patient Applicability with Polymer Sealing Ovation Alto Stent Graft (ELEVATE) IDE clinical study has begun enrollment and treatment of its first patients. According to the company, ELEVATE IDE aims to evaluate the safety and effectiveness of the Ovation Alto Abdominal Stent Graft System for the repair of infrarenal abdominal aortic aneurysms (AAAs).
The clinical trial has been approved to enroll 75 patients at up to 12 centers in the United States, reports the company. Steve Henao, MD, Chief of the Division of Vascular Surgery at New Mexico Heart Institute, performed the first procedure in the clinical trial.
According to Endologix, the Ovation Alto employs conformable O-rings with CustomSeal polymer that have been repositioned near the top of the endograft, which provides a seal just below the renal arteries. The device is the most recent addition to Endologix’s Ovation platform of abdominal stent graft systems, which the company notes have proven clinical outcomes as reported in the Ovation global pivotal trial and European Post-Market Registry.
The study’s principal investigator, Sean Lyden, MD, commented in the company’s announcement, “We are excited to start treating patients in the ELEVATE IDE trial. The polymer technology in the device allows for active sealing in the aortic neck. The polymer sealing ring has proven durability in maintaining aneurysm exclusion to 5 years as reported in the Global Ovation Pivotal Trial. The repositioning of the sealing ring to 7 mm below the top of the fabric will allow treatment of more challenging and complex anatomies in this trial." Dr. Lyden is Chairman of the Department of Vascular Surgery at Cleveland Clinic
Ovation Alto is an investigational device and currently not approved in any market. Endologix anticipates the Ovation Alto will be available in the United States in 2019.