Xlumena, a California-based developer, manufacturer and marketer of image-guided therapeutic endoscopy devices for the gastroenterologist/interventional endoscopist, has received clearance from the FDA to market Navix Access Device.
Xlumena Navix Device is an endoscopy system, consisting of a multi-lumen catheter with a trocar, anchor and dilation balloons and two guidewire ports, designed to enable secure access, dilation and delivery of guidewires for pseudocyst and abscess drainage procedures.
Xlumena will initially make the Navix Access Device available to a select number of interventional endoscopy centers across the US. The clearance follows the Xlumena AXIOS translumenal gallbladder stent and delivery system receiving a humanitarian use designation by the FDA.
FDA clearance for the AXIOS stent and delivery system is pending.
Michael Allen, president and CEO of Xlumena, said: “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.”
Kenneth Binmoeller, medical director of the Interventional Endoscopy Center at California Pacific Medical Center in San Francisco, said: “Xlumena has accurately identified some of the technical challenges, the interventional endoscopists are struggling with, and is developing simple, elegant solutions with products such as the Navix Access Device.