Glaukos gets the OK from Japan for its iStent device designed to treat glaucoma


Orange County, California-based Glaukos announced that the approval indicates use of the device, along with cataract surgery, makes it the first micro-invasive glaucoma surgery in Japan. The device is inserted into the eye using a small corneal incision through the Schlemm’s canal. Using this method allows the eye to continue draining fluid and relieving pressure.
Glaukos received pre-market approval for the iStent from the FDA back in 2012 – the first of its kind to do so in the United States, and according to the company’s website, this is actuall the smallest device to be approved by the FDA thus far.
Glaucoma is the second leading cause of blindness worldwide…..
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Source: Med City News
About iStent:  Connecting Patients to the Promise of Micro Invasive Glaucoma Surgery
iStent is the first MIGS device that improves your eye’s natural fluid outflow to safely lower eye pressure by creating a permanent opening in the trabecular meshwork. Proven safe and effective, the iStent Trabecular Micro-Bypass:

  • Is safely implanted during cataract surgery
  • Spares important eye tissue that is often damaged by traditional surgeries
  • Does not limit treatment options that could help maintain your vision in the future

iStent is the smallest medical device ever approved by the FDA. It is placed in your eye during cataract surgery and is so small that you won’t be able to see or feel it after the procedure is over. iStent is designed to create a permanent opening in your trabecular meshwork, and works continuously to improve the outflow of fluid from your eyes to help control eye pressure.
For patients with combined cataract and open-angle glaucoma, iStent reduces introcular pressure (IOP) by improving aqueous humor outflow. Inserted through a 1.5-mm corneal incision, iStent is the only FDA-approved device for the treatment of mild to moderate open-angle glaucoma.
“Bypassing the source of resistance and improving the functionality of the conventional outflow system is an ideal approach to managing OAG.”
Tom Samuelson, MD