July 30, 2020
Endologix Launches the Alto Abdominal Stent Graft System in the United States
July 30, 2020—Endologix Inc. announced the United States commercial release and the first commercial implantation of the company's Alto abdominal stent graft system for the treatment of abdominal aortic aneurysms. Endologix announced FDA approval of the Alto endograft in March 2020.
According to the company, the Alto is a workhorse endograft with broad indications to treat the widest range of patients. The device features an anatomically adaptive sealing technology and 7-mm neck indication to provide a precise seal near the renal arteries.
In addition, Alto's low profile (15-F outer diameter) enables treating patients with small vessels and challenging access. An integrated balloon helps optimize the seal during the procedure.
Endologix noted that its core anatomically adaptive sealing technology has been studied in in the ELEVATE investigational device exemption (IDE) trial and the ENCORE database. ENCORE demonstrated favorable midterm durability evidenced by successful aneurysm exclusion and 5-year freedom from aneurysm-related mortality.
Sean Lyden, MD, National Primary Investigator for the ELEVATE IDE trial, performed the first commercial implant of the Alto endograft. Dr. Lyden is Chairman of the Department of Vascular Surgery, Cleveland Clinic in Cleveland, Ohio.
“This new endograft, as seen in the ELEVATE IDE trial, has allowed us to treat patients on label with short necks and challenging access without adjunctive devices or access routes,” commented Dr. Lyden in the company's announcement. “A device with a polymer sealing ring at 7 mm has expanded the number of patients that can be offered minimally invasive endovascular repair that are not treatable with other commercial infrarenal fixation devices.”