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Ophthalmology:
Våra terapiområden

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      • XEN logotype
      XEN45 Directions for Use
      Mode of Action Video
      XEN63 Directions for use

      Mastering XEN™, 6-steps.1,2

      Plan XEN location before​ making incisions.

      Advance needle through sclera.

      Continue to advance​ the needle.

      Deliver XEN™ through​ gentle actuation of slider.

      Confirm XEN™ position in sub-conjunctival space and anterior chamber.

      Confirm significant bleb​ with priming.

      XEN™ troubleshooting1,2

      Troubleshooting deployment

      Implant repositioning

      XEN™ Surgical techniques1,2​

      The challenge of fibrosis

      ​Subconjunctival tissue can sometimes form postoperatively and trap the XEN implant in tenons.​

      The area involved in filtration becomes limited due to mechanical obstruction. This can lead to further fibrosis and an increased IOP. Normally this would require postoperative needling to free the implant and allow restoration of the flow.

      Primary needling

      The XEN ab interno implantation combined with intraoperative needling after implantation is a technique often referred to as primary needling. ​

      ​The purpose is to rupture tissue adhesion ensuring a low and diffuse bleb. A 30G needle is used to sweep above and below the stent.​ The objective is a free and mobile implant, reducing the need for postoperative needling and unnecessary clinic visits.​

      Needling overview

      Primary needling, Dr Nathan Kerr​.

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      Read more about glaucoma

       

      Abbreviated DFU XEN Gel Implant.1,2​

       

      XEN INJECTOR​
      The XEN Injector is a single use mechanical delivery system for the XEN Gel Implant. The Gel Implant is preloaded in the XEN Injector which houses the Gel Implant during insertion and delivery into the eye. The XEN Injector allows the surgeon to advance and deliver the Gel Implant to the desired location.​

      INDICATIONS​
      The XEN Gel Implant is intended to reduce intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed.​

      ​CONTRAINDICATIONS​
      The XEN Gel Implant is contraindicated under the following circumstances or conditions: Angle closure glaucoma, previous glaucoma shunt/valve in the target quadrant, presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant, active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis), active iris neovascularization or neovascularization of the iris within six months of the surgical date, anterior chamber intraocular lens, presence of intraocular silicone oil, vitreous present in the anterior chamber, impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure), known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde), history of dermatologic keloid formation.​

      WARNINGS​
      The following may occur in conjunction with the use of the XEN Gel Implant: Gel Implant migration, Gel Implant exposure or extrusion, ​
      Gel Implant blockage, choroidal effusion or hemorrhage, hypotony maculopathy, bleb related complications, choroidal detachment, conjunctival perforation, conjunctivitis, eye injury, fibrosis, high intraocular pressure, inflammation/irritation, irido-corneal touch, iridodialysis/iris rupture, iritis, lack of effectiveness, lacrimation, low intraocular pressure, malignant glaucoma, ocular pain, vision abnormalities, vision loss or endophthalmitis and other known complications of intraocular surgery (e.g., flat or shallow chamber, ​hyphema, corneal edema, macular edema, retinal detachment, vitreous hemorrhage, uveitis).​

      ​PRECAUTIONS​

      1. The XEN Gel Implant and Injector should be carefully examined in the operating room prior to use​

      2. The patient’s IOP should be monitored postoperatively. If the IOP is not adequately maintained after surgery, a therapeutic regimen or further intervention to reduce IOP should be considered.​

      3. In order to minimize trauma to the eye and associated complications, it is essential that the Gel Implant is placed in the proper subconjunctival location.​

      4. If increased resistance is observed at any time during the implantation procedure, stop the implantation procedure and use a new Injector.​

      ​

      References and abbreviations

      1. XEN63 Directions For Use 5501-001 May-2019. ​

      2. XEN45 Directions For Use 5507-001 Dec-2019.​

      SE-XEN-240017 v. 1.0 November 2024