Endologix Receives FDA Approval for Alto Abdominal Stent Graft System
ENDOLOGIX (ELGX)
Last endologix earnings: 2/19 04:01 pm
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Source: Business Wire
IRVINE, Calif.--(BUSINESS WIRE)--Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that it has received approval from the United States 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 intra-proc
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