Endologix today said it received FDA approval for its Alto abdominal stent graft system.
The company said it received approval based on its regulatory submission that included results from its Elevate Investigational Device Exemption clinical study. Under the terms of the FDA approval, the first 100 patients after commercial launch will be included in a post-approval imaging study to determine the consistency in device selection between the company’s internal imaging services and implanting physicians.
“We are thrilled to receive approval for the Alto system,” chief medical officer Matt Thompson said in a news release. “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. 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.”
The Alto Abdominal Stent Graft System is an Ovation system for polymer endovascular aneurysm repair.
“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),” 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. We are committed to proving the superiority of this product over traditional undifferentiated EVAR grafts in a randomized clinical trial while remaining steadfastly focused on re-establishing durable, predictable growth through a continued focus on execution and evidence-driven differentiation.”