Xlumena Receives FDA Clearance for NAVIX Access Endoscopy Device

Xlumena, a privately held provider of innovative technology for gastroenterologists and interventional endoscopists, has received clearance from the US Food and Drug Administration to market its NAVIX Access Device, an advanced endoscopy system designed to enable secure access, dilation and delivery of guidewires for pseudocyst and abscess drainage procedures, according to an Xlumena news release.

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The NAVIX device consists of a multi-lumen catheter with a trocar, anchor and dilation balloons and two guidewire ports. Xlumena will initially make the device available to a select number of interventional endoscopy centers across the U.S., according to the release.

“We are pleased to introduce the NAVIX Access Device, the first in a line of revolutionary products under development, based on Xlumena’s Advanced Translumenal Therapy technology,” Michael Allen, president and CEO of Xlumena, said in the release. “We believe this is an important first step in providing the interventional endoscopist with innovative tools that will enable a broader reach within the specialty and take interventional endoscopy to a new therapeutic level.”

Read the Xlumena release on the NAVIX Access Device.

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