03.04.15
AqueSys Inc., a developer of minimally invasive stent technology for the treatment of glaucoma, has completed enrollment in the U.S. investigational study of the XEN 45 Gel Stent. According to the company, the technology under review is the first glaucoma device designed to achieve similar intraocular pressure (IOP) reduction as traditional subconjunctival trabeculectomy and tube-shunt procedures through a minimally invasive technique with less associated surgical and post-operative risk.
The study, a prospective, multicenter single-arm clinical trial conducted at 12 sites within the United States, is designed to evaluate the safety and performance of the AqueSys XEN 45 Gel Stent in subjects with refractory glaucoma where previous glaucoma treatments were not effective. The company will collect 12-month data on all subjects and submit the data to the U.S. Food and Drug Administration to seek market clearance.
“Enrollment was completed within the study’s prescribed timeframe. We are pleased to achieve this milestone and look forward to obtaining all of the results and pursuing U.S. market clearance,” said Ron Bache, CEO of AqueSys. “With commercialization going very well in Europe and our recent approval in Canada, the XEN Gel Stent is well positioned for success in the U.S.”
The XEN Gel Stent is implanted using a disposable injector with a small 27-gauge needle pre-loaded with the stent. Once in place, the soft, permanent gelatin stent is designed to minimize known complications related to synthetic materials. The proprietary stent technology uses physics to control aqueous fluid flow to lower IOP significantly, yet protect against the hypotony (too low of pressure) associated with current subconjunctival procedures.
“My initial impression of the XEN 45 Gel Stent, based on my experience as a clinical investigator in a trial for patients with refractory glaucoma, is excitement. I eagerly await adding it to my clinical practice,” said William J. Flynn, M.D., a glaucoma specialist in private practice in San Antonio, and a clinical professor of ophthalmology at the University of Texas Health Science Center at San Antonio. “The XEN 45 stent procedure is unique among glaucoma surgeries; it is minimally invasive yet results in an effective filtering bleb that is safer and more comfortable for patients.”
AqueSys is privately held and based in Aliso Viejo, Calif.
The study, a prospective, multicenter single-arm clinical trial conducted at 12 sites within the United States, is designed to evaluate the safety and performance of the AqueSys XEN 45 Gel Stent in subjects with refractory glaucoma where previous glaucoma treatments were not effective. The company will collect 12-month data on all subjects and submit the data to the U.S. Food and Drug Administration to seek market clearance.
“Enrollment was completed within the study’s prescribed timeframe. We are pleased to achieve this milestone and look forward to obtaining all of the results and pursuing U.S. market clearance,” said Ron Bache, CEO of AqueSys. “With commercialization going very well in Europe and our recent approval in Canada, the XEN Gel Stent is well positioned for success in the U.S.”
The XEN Gel Stent is implanted using a disposable injector with a small 27-gauge needle pre-loaded with the stent. Once in place, the soft, permanent gelatin stent is designed to minimize known complications related to synthetic materials. The proprietary stent technology uses physics to control aqueous fluid flow to lower IOP significantly, yet protect against the hypotony (too low of pressure) associated with current subconjunctival procedures.
“My initial impression of the XEN 45 Gel Stent, based on my experience as a clinical investigator in a trial for patients with refractory glaucoma, is excitement. I eagerly await adding it to my clinical practice,” said William J. Flynn, M.D., a glaucoma specialist in private practice in San Antonio, and a clinical professor of ophthalmology at the University of Texas Health Science Center at San Antonio. “The XEN 45 stent procedure is unique among glaucoma surgeries; it is minimally invasive yet results in an effective filtering bleb that is safer and more comfortable for patients.”
AqueSys is privately held and based in Aliso Viejo, Calif.