Gel stent approved in Canada

AqueSys announced that Health Canada has approved its XEN Gel Stent, a minimally invasive subconjunctival stent to treat primary open-angle glaucoma.

“AqueSys has reinvented the approach to sub-conjunctival outflow. It’s the same space surgeons have trusted for close to 100 years, but we’ve never had a minimally invasive procedure to get access to it. This offers the advantage of a simpler and safer way of doing a well-recognized procedure,” said Iqbal “Ike” Ahmed, MD, assistant professor and research director at the Kensington Eye Institute at the University of Toronto. “The mechanism of action of the XEN allows for a target pressure in the low teens, which makes it suitable for a broad range of glaucoma stages. I’ve used it with and without cataract surgery with similar efficacy.”

Canadian distributor Salient Medical Solutions is expected to begin shipping the device in Canada immediately.

The gel stent received the CE mark in Europe in 2014. It is an investigational device in the United States, where it has not yet received regulatory approval.