The MicroShunt is the first minimally invasive device for the treatment of mild, moderate, and severe POAG that promises to sustain IOP below 15 mm Hg and eliminate eye drop medications for most patients. It is also the only device in a randomized, controlled trial versus trabeculectomy.
“What we see in studies outside the United States is that the acute hypotony rate is a fraction of what you see with trabeculectomy, and chronic hypotony just isn’t there,” said Russ Trenary, president and CEO. “For the glaucoma surgeon, having an alternative to trabeculectomy is going to be wonderful, not just in the operating room, but postoperatively.”
The device is made of SIBS, used in more than a million cardiac patients over 15 years and as an investigational ophthalmic product for more than eight years.
A pooled analysis of over 300 patients with baseline IOP of 23 mm Hg and 3 medications showed an IOP of less than 15 mm Hg and 60% of patients are completely off glaucoma medications. The device can be used with or without cataract surgery and is expected to last the lifetime of the patient.
The Hydrus Microstent is the only device that dilates and reconstructs Schlemm’s canal. About 3,000 of the devices have been implanted and results of a pivotal U.S. trial are due later in 2017.
“We have tremendous confidence,” said Brett Trauthen, chief scientific officer. “In a smaller version of this pivotal trial published in 2015, 80% of patients showed at least a 20% drop in diurnal IOP after 2 years. That is the highest absolute response rate ever reported in a MIGS study.”
The device is introduced using a metal cannula that incises the trabecular meshwork (TM) and advances into the canal. Surgeons report placement is easy to verify and there have been no reports of device migration or loss.
The next step is a 24-hour IOP monitor attached to the stent. Working prototypes report through an iPhone and are in active development.
The device is also a potential platform for drug delivery. Ivantis is developing an ophthalmic-eluting stent using the same coating used on drug-eluting coronary stents.