The US Food and Drug Administration (FDA) has approved Endologix Alto Abdominal Stent Graft System designed to expand the endovascular aneurysm repair (EVAR) for treating affected patients.
The approval comes from the regulatory submission by the company that includes the ELEVATE Investigational Device Exemption (IDE) clinical study.
In the ELEVATE study, researchers tested the safety and effectiveness of the Alto system in 75 patients at up to 12 centres in the US.
The company notes that the first 100 patients after the commercial launch of the device will be included in a post-approval imaging study, under approval terms, determining consistency in device selection between the company’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 commercialisation.
“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.
“However, as we expect Ovation iX to remain commercially available for a period of time subsequent to the Alto launch, we will also be updating our previous 2018 safety communication as it relates to the Ovation iX system.”
FDA approval should serve as a landmark for the company as it seeks to introduce a portfolio of devices to address the current unmet needs of EVAR.
Endologix CEO John Onopchenko said: “We believe Alto’s ultra-low profile and its 7mm aortic neck length indication give it the broadest applicability of any endograft in the US.”