When you approach something new in medicine, with no outside frame of reference or comparators, it can take a lot of effort to shift the industry mindset and, eventually, the treatment algorithm.
When Glaukos brought to market the iStent® Trabecular Micro-Bypass for the treatment of mild-to-moderate open-angle glaucoma in 2012, they weren’t just introducing ophthalmologists to a new device, but rather an entirely new category of glaucoma surgery.
As the first microinvasive glaucoma surgery (MIGS) implant, iStent faced an uphill battle. With a dedicated approach to educating both ophthalmologists and patients, a mountain of peer-reviewed studies documenting its safety and efficacy, and a company dedicated to refining and improving its technologies, the iStent family of technologies has now been implanted in more than 1 million procedures worldwide, far exceeding any other MIGS procedure or device.
One of the things that helped cement the iStents place in the management of glaucoma is the benefit it brings to patients with mild to moderate glaucoma. MIGS helps to fill the middle ground between drops and invasive surgery. The minimally invasive procedure can safely and effectively lower IOP in patients with mild-to-moderate disease, potentially slowing down the number of patients progressing to an advanced stage of glaucoma. Because the product is indicated for use at the time of cataract surgery, the treatment of patients with mild-to-moderate glaucoma can fall to general ophthalmologists and cataract surgeons, and glaucoma specialists can then focus more on those patients who have advanced disease.
The iStent has now been in use for more than a decade and its safety and efficacy has long been established. With more than 200 peer-reviewed articles published on iStent technology, there is no doubt that these devices work, and they work well.
The confidence behind the utilization of the product adds to its continued growth.
Today, more surgeons than ever are adopting MIGS into their practice due in part to the continued education surrounding these procedures and an increasing portfolio of available MIGS devices.
The latest in the iStent family—the iStent infinite—builds off previous iStent technology, with several big differences that have the potential to change glaucoma management in a way similar to the first iStent in 2012.
It’s been previously established1 that two stents are more efficacious than one and three stents are more efficacious than two. The first stent does the majority of the IOP reduction, but when a second stent is added, there is an additional incremental benefit. And if a third stent is added, there is another incremental benefit.
The iStent infinite will keep the same wide flange as the current iStent inject W but there will be an added stent for a total of 3. The injector system of the iStent inject will also allow an unlimited number of shots, an upgrade from the 4 shots allowed with the iStent inject.
Another major difference is that unlike previous generations, iStent infinite isn’t indicated for a specific stage of disease, but rather for patients who have failed both medical and surgical intervention or therapy. It also has a standalone indication, so it isn’t tied to being implanted alongside cataract surgery.
As the concept of interventional glaucoma—the mindset of intervening earlier in the disease progression—begins to evolve, iStent infinite, with its broad indications, offers an avenue for many more patients to forego additional drops that rarely deliver their intended benefits and undergo proven surgical intervention before requiring a more invasive filtering surgery.
The MIGS revolution may have started with iStent, but with each subsequent device—iStent inject, iStent inject W, and the forthcoming iStent infinite— the treatment landscape has changed for glaucoma patients.
Reference
Katz LJ, Erb C, Carceller A, et al. Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication. Clin Ophthalmol. 2015;9:2313–2320.
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