In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests. 

Fun fact: January is National Glaucoma Awareness Month! Maybe you already knew that, and if you did, great! If not, we’ve got you covered. We are going to do our best to bring even more awareness to glaucoma, and as we do in every Medical Device Monday, we’ll feature a medical device that’s been around for a while that is specific to glaucoma patients called the iStent inject®.

To start off, glaucoma is a progressive eye condition that causes damage to the optic nerve of the eye which frequently leads to vision damage and ultimately blindness when left completely untreated. The optic nerve is essentially the telephone line from the eye to the brain, responsible for transmitting impulses to the brain from the retina. There is a fluid in the eyes that helps maintain the shape of the eye, and normally, the fluid drains on its own and is absorbed into the bloodstream. However, when that fluid is unable to drain, pressure builds up in the eye, and the optic nerve becomes compressed and leads to cell death. There is currently no complete cure for glaucoma, however, there are medical devices that help slow the degeneration and drain the liquid buildup. Enter, the iStent inject®.

iStent inject by Glaukos, is one of the medical devices that is FDA approved to help patients with glaucoma. The iStent inject is one of the world’s smallest medical devices that can be implanted in the human body (look closer at that image of the penny and you’ll see it in front of Lincoln’s nose). iStent inject is used in conjunction with cataract surgery to reduce the eye pressure that leads to vision loss and is indicated only for patients with mild to moderate primary open-angle glaucoma. [FYI: open-angle glaucoma is the most common type of glaucoma, and is when the drainage canals become clogged even though the angle in your eye where iris and cornea meet are normal. This is different from angle-closure glaucoma, where the drainage pathways are blocked by the iris.] Typically, glaucoma mainly affects adults around 40 years and older (although it is possible for children and infants to have it), and iStent inject is only approved for adults at this time.

The iStent inject creates two permanent openings between the front of your eye and its natural drainage pathway to increase the flow of fluid (via tiny tubes, or stents), improving and maintaining the overall outflow of fluid to create a lower pressure. Once implanted, the patient should not be able to see or feel the medical device in their eye. The iStent inject is one of the many ways that medical devices, science, technology all help to decrease patient discomfort and help patients with a debilitating disease like glaucoma! Glaukos has every right to consider changing their tag line for the iStent inject to “I swear, it’s for my glaucoma.”

Additional Reading:

  1. More info about the iStent inject device from Glaukos

  2. FDA approval letter for P170043

  3. Video of the iStent inject being implanted (not for people who don’t like videos of eyes being poked!)

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