5513-001: AbbVie Allergan XEN 45 Gel Stent Ophthalmic Implant, Glaucoma Treatment System

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AbbVie Allergan XEN Gel Stent

The Allergan XEN® Gel Stent is a minimally invasive surgical implant used to lower intraocular pressure (IOP) in patients with primary open-angle glaucoma or other forms of refractory glaucoma that have not responded adequately to medical therapy or previous surgical treatment.

It’s a soft, permanent tube—about 6mm long—made from porcine-derived gelatin cross-linked with glutaraldehyde to maintain shape and biocompatibility. The device is implanted through an ab interno (from inside the eye) or ab externo (from outside the eye) approach to create a channel that allows aqueous humor to drain from the anterior chamber to the subconjunctival space, bypassing the trabecular meshwork.

By providing this new outflow pathway, the XEN® Gel Stent helps reduce IOP while minimizing the amount of conjunctival and scleral dissection required compared to traditional filtering surgeries like trabeculectomy.

Product Code: 5513-001

• XEN 45 Gel Stent, Preloaded into a XEN Injector
• Length: 6mm

Sterilization

• Device Packaged as Sterile: Yes
• Requires Sterilization Prior to Use: No 
• Single-Use
• Disposable

Additional Details

• Company Name: Allergan, Inc.
• FDA Product Code: KYF
• FDA Product Code Name: Implant, Eye Valve 
• GMDN Term Code: 61127
• GMDN Term Name: Glaucoma Shunt
• GMDN Term Definition: A non-bioabsorbable, implantable ocular device intended to create an artificial drainage channel for diversion of aqueous humour from the anterior chamber of the eye to reduce intraocular pressure (IOP) as an alternative to, or after failed, trabeculectomy, for the management of uncontrolled glaucoma. It consists of a tube which is introduced into the aqueous body (typically via limbal entry) and a distal episcleral plate intended to support a reservoir of aqueous humour; the shunt does not contain a valve.

Allergan, an AbbVie company, is a global pharmaceutical and medical aesthetics leader known for developing innovative therapies and products across eye care, neurology, gastroenterology, and aesthetics. Headquartered in Irvine, California, Allergan is recognized for its portfolio of market-leading brands, including Botox®, Juvederm® dermal fillers, and a range of ophthalmic surgical and therapeutic solutions. In the surgical space, Allergan offers implants, devices, and biologics used in plastic surgery, ophthalmology, and reconstructive procedures. With a focus on scientific research, product safety, and physician partnership, Allergan serves healthcare providers and patients in more than 100 countries.