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    MIGS driving the device market

     

    AqueSys

    The Xen gelatin stent finished enrollment on its first IDE study in the United States and is enrolling patients for its second IDE trial. Clinical trial data collected on the soft gelatin stent are uniformly encouraging.

    “We reduce IOP toward the mid-teens and we are getting significant reductions in glaucoma medication use,” said Barbara Niksch, vice president for clinical and regulatory affairs. “Once we get a month out from implantation, pressures are stable. In the longer term, we are seeing low- to mid-teen IOPs plus continuing medication reduction.”

    Xen is a soft, compressible and tissue-conforming stent, designed to mitigate traditional implant issues. The device and its pre-loaded injector can be used with or without cataract surgery. The stent creates an ab interno bleb and drains aqueous using the subconjunctival outflow pathway. Mean IOP drops about 30% from baseline in early generation devices and close to 40% using the latest version plus mitomycin C.

    “This is direct subconjunctival outflow that bypasses all potential outflow obstructions,” she said. “There is absolute certainty of outflow and a single implant delivers the desired efficacy. Our international studies demonstrate success in all stages of glaucoma.”

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