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AqueSys completes enrollment for clinical trial of Xen 45 gel stent

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AqueSys has completed enrollment in a U.S. investigational study of the Xen 45 gel stent, according to a press release.

The stent is designed to achieve IOP reduction through a minimally invasive technique using a disposable injector with a 27-gauge needle pre-loaded with the device.

The 12-month prospective multicenter single-arm clinical trial will evaluate the safety and performance of the stent among refractory glaucoma patients who have had previous ineffective treatments. AqueSys will then submit the data to the FDA to seek market clearance, the release said.

“We are pleased to achieve this milestone and look forward to obtaining all of the results and pursuing U.S. market clearance,” Ron Bache, CEO of AqueSys, said in the release. “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.”