AqueSys, Inc.
World’s First Minimally Invasive Sub-conjunctival Stent Modernizes the Traditional Glaucoma Procedure Resulting in Highly Effective IOP Reduction and Improved Safety
AqueSys, Inc., the developer of minimally invasive stent technology for the treatment of glaucoma, announced today that the company received a Class 3 Medical Device License for the XEN Gel Stent from Health Canada, allowing the device to be sold in Canada. AqueSys has chosen Salient Medical Solutions as the Canadian distributor and commercialization is expected to begin immediately. The XEN Gel Stent is intended to reduce intraocular pressure (IOP) in patients with primary open angle glaucoma where previous medical treatments have failed.
Glaucoma affects more than 400,000 Canadians and 67 million people worldwide according to the Glaucoma Research Society of Canada. The CNIB (Canadian National Institute for the Blind) identifies glaucoma as the second leading cause of vision loss in Canada and, importantly, more than 250,000 Canadians have primary open-angle glaucoma, the most common form of the disease.
Primary open angle glaucoma gradually reduces peripheral vision without other symptoms. If the IOP remains high, the optic nerve destruction can progress until all vision is lost. The XEN Gel Stent is the first glaucoma device to achieve similar IOP reduction as traditional sub-conjunctival trabeculectomy and tube shunt procedures through a minimally invasive technique with less associated surgical and post-operative risk.
“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, M.D., assistant professor and research director at the Kensington Eye Institute, 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.”
AqueSys began commercial activities in Europe in 2014, where it has CE mark, and more than 1800 XEN Gel Stents have been implanted to date. “AqueSys is pleased to introduce the XEN Gel Stent technology to Canadian ophthalmologists which will enable them to deliver gold standard efficacy to their patients through a minimally invasive, standardized procedure,” said Ron Bache, CEO of AqueSys.