The XEN Gel Stent is made of a permanent, soft, collagen-derived, gelatin about 6 mm long. Upon implantation, it creates a gentle, diffuse outflow of aqueous from the anterior chamber into the non-dissected tissue of the subconjunctival space. The ab-interno procedure requires no tissue dissection or suturing.
Although the device creates a bleb, there are not conjunctival incisions.
“It’s strong enough for severe disease, but is safe enough for mild disease,” Bache said. The device bypasses all the potential outflow obstructions and introduces a new, patent outflow pathway.
“One stent is enough to get the desired efficacy,” he said. With 3 years’ data (n=852), pressures were reduced to 13.2 mm Hg, a 40% reduction from best-medicated pressure readings. A study on the latest generation XEN 45 (n=570) resulted in average pressures in the 11-12 mmHg range, with a 40% reduction from best-medicated pressures.
Already approved in Canada and Europe, AqueSys plans to file for U.S. approval late next year.
Ron Bache is President and CEO of AqueSys, Inc. AqueSys is a venture capital backed medical device company focused on the development, and commercialization of innovative, safe, and effective implantable devices for the treatment of glaucoma.