ALISO VIEJO, Calif.--(BUSINESS WIRE)--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.
About Salient Medical Solutions
Salient Medical Solutions is the exclusive Canadian distributor of the XEN Gel Stent. Since its foundation, Salient has been committed to improving Canadian healthcare by introducing new and emerging medical technologies to the healthcare industry.
About AqueSys, Inc.
AqueSys, Inc. is the first ophthalmic device company to focus exclusively on the treatment of glaucoma by re-envisioning sub-conjunctival outflow with a minimally invasive stent for the reduction of intraocular pressure. Backed by more than a decade of research and recent commercialization in European markets, the safety and efficacy of the company’s proprietary technology supports glaucoma surgeons and patients in the management of intraocular pressure to arrest the progression of vision loss associated with glaucoma. Privately held and headquartered in Southern California, AqueSys is working to change the treatment of glaucoma to benefit patients, physicians and payors around the world through the research, development, manufacturing and commercialization of its minimally invasive glaucoma stents. Additional information about the XEN Gel Stent can be found at www.aquesys.com.
Caution: In the United States, the XEN Gel Stent is an investigational device and is limited by Federal (United States) law to investigational use.