March 16, 2020
Endologix Receives FDA Approval for Alto Abdominal Stent Graft System
March 16, 2020—Endologix Inc. announced that it has received FDA approval for the Alto abdominal stent graft system for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms.
Under the terms of approval, the first 100 patients after commercial launch will be included in a postapproval imaging study to determine consistency in device selection between Endologix’s internal imaging services and those of the implanting physicians.
Endologix stated that the Alto EVAR device features an ultra-low profile and a 7-mm aortic neck length indication, and that Alto is designed to enhance ease of use, improve acute outcomes, and preserve the long-term durability associated with patient-specific anatomically adaptive sealing. The company anticipates observing improved short-term outcomes relative to its Ovation iX system as a result of the design and manufacturing changes incorporated into Alto.
According to the announcement, FDA approval of the device is supported by data from the ELEVATE investigational device exemption (IDE) clinical study. Enrollment in the ELEVATE trial commenced in March 2017 and was completed in February 2018.