Endologix recently announced that it has received approval from the US Food and Drug Administration (FDA) for the Alto abdominal stent graft system (Alto).
The company received approval based on its regulatory submission that includes the ELEVATE investigational device exemption (IDE) clinical study. Pursuant to the terms of approval, the first 100 patients after commercial launch will be included in a post-approval imaging study to determine consistency in device selection between Endologix’s internal imaging services and those of the implanting physicians.
“We are thrilled to receive approval for the Alto system,” commented Matt Thompson, chief medical officer of Endologix. “We have worked collaboratively with the FDA throughout the Alto premarket approval (PMA) process, and we will be carefully monitoring intraprocedural events as Alto ramps to full commercialisation.”
He continued: “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.”
“Alto approval is a critical landmark for Endologix as we seek to introduce a portfolio of devices to address the current unmet needs of endovascular aneurysm repair (EVAR),” commented John Onopchenko, chief executive officer of Endologix. “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.”