Alto system’s approval was based on data from the ELEVATE investigational device exemption clinical study
The US FDA’s Center for Devices and Radiological Health (Credit: The U.S. Food and Drug Administration)
Endologix has secured approval from the US Food and Drug Administration (FDA) for its Alto abdominal stent graft system.
The FDA approval of Alto system was based on data from the ELEVATE investigational device exemption (IDE) clinical study.
To meet the terms of the approval, the first 100 patients after the commercial introduction will be included in a post-approval imaging study to assess consistency in device selection between Endologix’s internal imaging services and those of the implanting physicians.
Endologix chief medical officer Matt Thompson said: “We have worked collaboratively with the FDA throughout the Alto premarket approval (PMA) process, and we will be carefully monitoring intra-procedural events as Alto ramps to full commercialization.
“We anticipate observing improved short-term outcomes relative to the Ovation iX Abdominal Stent Graft System (Ovation iX) as a result of the design and manufacturing changes incorporated into Alto.”
Endologix focuses on development of devices for endovascular aneurysm repair
The approval of Alto is a significant step for the company, as it is focusing on the development of devices to better address the current unmet requirements of endovascular aneurysm repair (EVAR).
Alto is said to be a differentiated EVAR device, which provides better design features that will help advance ease of use, improve acute outcomes, and protect the long-term durability linked with patient-specific anatomically adaptive sealing.
Endologix CEO John Onopchenko said: “Alto is a differentiated EVAR device that offers significant design features that we believe will enhance ease of use, improve acute outcomes, and preserve the long-term durability associated with patient-specific anatomically adaptive sealing.
“We believe Alto’s ultra-low profile and its 7mm aortic neck length indication give it the broadest applicability of any endograft in the U.S.”
Endologix is engaged in the development and manufacturing of minimally invasive treatments for aortic disorders. It mainly works on the development of endovascular stent-grafts to treat abdominal aortic aneurysms (AAA).
In June last year, the company announced the reinstatement of CE mark for its Nellix endovascular aneurysm sealing system.