The MicroShunt has just completed enrollment (n=75) in a pivotal study, and is the only device to be directly compared to trabeculectomy. The device has been used in humans for more than 12 years outside the U.S., with mean postop pressures below 14 mmHg. The pressure reduction seen at 3 months holds through 3 years.
“We simply don’t require cataract removal to get the results we’re achieving,” Trenary said. The device itself is 8.5 mm, with a 350 micron outer diameter and a 70 micron lumen.
An 82-patient study found pressures dropped from 23 mmHg to 10.9 mmHg, sustained through month 35. At all follow-up time points through 3 years (n=22), 80% of patients were below 14 mmHg and 73% completely medication-free. There were no unresolved adverse events. Results were compatible in a group of patients considered early stage as well, with pressures dropping from 24.7 mmHg to 11.6 mmHg at year 3.
Russ Trenary is President & CEO for InnFocus, Inc., an early stage company pioneering a microsurgical solution for glaucoma.
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