Endologix, an Irvine, California-based healthcare technology company, has received FDA approval for its new abdominal stent graft solution.
The Alto Abdominal Stent Graft System is approved for the treatment of patients with infrarenal abdominal aortic aneurysms. The agency’s approval states that, after the product’s commercial launch, the first 100 patients must be included in a post-approval imaging study to confirm consistent results.
“We are thrilled to receive approval for the Alto system,” Matt Thompson, chief medical officer of Endologix, said in a prepared statement. “We have worked collaboratively with the FDA throughout the Alto premarket approval process, and we will be carefully monitoring intra-procedural events as Alto ramps to full commercialization.”
“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),” John Onopchenko, CEO of Endologix, said in the same statement. “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 7-mm aortic neck length indication give it the broadest applicability of any endograft in the U.S.”