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    Device makers swing for fence with new technologies

     

    InnFocus

    InnFocus has a simple goal, said Russ Trenary, president and CEO. It wants to treat the entire gamut of glaucoma, mild to severe, bringing IOP to 15 mm Hg or lower with a single device, the MicroShunt.

    “We want patients who are coming in with a high IOP on maximum medications and get them below 15 mm Hg so they don’t lose vision any longer,” Trenary said. “And be able to get these patients off their eye drops.”

    Early clinical data suggest it can be done. The MicroShunt uses a 70-µm lumen to tap the trabeculectomy aqueous drainage pathway. The key is the stent material, poly(styrene-block-isobutylene-block-styrene) or SIBS, that has more than 15 years of human use, including more than 8 years in ocular use, Trenary noted.

    News: Santen to acquire InnFocus, developer of glaucoma drainage implant

    The device meets American Glaucoma Society IOP goals even without cataract removal, Trenary said, with a greater than 40% IOP lowering from baseline on full medications to less than 15 mm Hg. International trials show more than 80% of eyes with an IOP of less than 15 mm Hg, more than 80% reduction in glaucoma medications to a mean of 0.6 medications per patient and more than 70% of patients free of glaucoma medications 3 years after implantation with no long-term, sight-threatening adverse events.

    The company enrolling patients for a phase III trial in the United States against trabeculectomy. A U.S. reimbursement code is already in place and the trabeculectomy trial is designed to meet pan European reimbursement requirements.

    “This is a game changer,” Trenary said. “We are the only device that will be able to say this is what happens compared to trabeculectomy.”

    MicroOptx

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