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    MIGS driving the device market



    Many glaucoma drug and device manufacturers see IOP reductions in the 30% to 35% range. InnFocus prefers to deal in absolute values. That means a device that could reliably bring IOP down to 14 mm Hg or lower using an inert biomaterial, a shunt design that remains patent without hypotony or leaks and an antiproliferative drug to minimize the initial surgical insult. The result is the InnFocus MicroShunt.

    The shunt is made of styrene-isobutylene-styrene (SIBS), the same material used for Taxus-eluting coronary stents. The flexible 8.5-mm device has a 0.07-mm lumen, large enough to allow cells to pass and small enough to prevent hypotony.

    “Data from the Dominican Republic and France show an average IOP of 11.2 mm HG that is flat out beyond 2 years,” said Russ Trenary, president and CEO. “Our mean IOP reduction was 55% and 82% percent of eyes had an IOP under 14 mm Hg. We saw an 83% reduction in medication use and 89% of patients were off all glaucoma meds. There were no long-term, sight-threatening adverse events, no endophthalmitis, no chronic hypotony, no choroidal hemorrhage. Now we have to replicate those results in the United States.”

    A multicenter IDE trial began in 2013, he continued. The study will compared the InnFocus device to trabeculectomy with a 2-year follow up period.

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