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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

      A less invasive ab interno MIBS which may bridge the gap between drops and traditional surgery1–5

      • XEN™ is the only ab interno micro-incisional filtration procedure that uses the trabeculectomy outflow pathway.1,2,6,7
      • XEN™ is a 6 mm gelatin implant, biocompatible and tissue-conforming.1,2,4
      • XEN™ is a class III Medical Device, CE2797.1,2​
      • Using the XEN micro-incisional procedure, the XEN™ implant is delivered via an ab interno approach, through a small corneal incision.1,2​
      • By avoiding subconjunctival dissection, XEN™ provides further options in patients for future corrective surgeries.1,2,8​

      There are two different XEN™ implants; XEN45 and XEN63, both with the same procedure and injector.1,2​

      XEN45

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      XEN63

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      The greater lumen diameter of XEN63 was designed to further decrease outflow resistance and improve the outflow of aqueous humour.1,2,9​

      Injector

      XEN™ Mode of Action

      eye
      Contact our XEN Surgical Specialist
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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.​

      3. Terminology and Guidelines for Glaucoma. Fifth edition. EGS. 2020. ​

      4. Vera, V.I., Horvath, C. (2014). XEN Gel Stent: The Solution Designed by AqueSys®. In: Samples, J.R., Ahmed, I.I.K. (eds) Surgical Innovations in Glaucoma. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-8348-9_17

      5. Ahmed II. MIGS and the FDA: What's in a Name? Ophthalmology. 2015 Sep;122(9):1737-9.​

      6. Pereira ICF, van de Wijdeven R, Wyss HM, et al. Conventional glaucoma implants and the new MIGS devices: a comprehensive review of current options and future directions. Eye (Lond). 2021 Dec;35(12):3202-3221. ​

      7. Manasses DT, Au L. The New Era of Glaucoma Micro-stent Surgery. Ophthalmol Ther. 2016 Dec;5(2):135-146. ​

      8. Vera, V. Ahmed, I. Stalmans, I. et al. US Ophthalmic Review. Gel Stent Implantation—Recommendations for Preoperative Assessment, Surgical Technique, and Postoperative Management. 2018;11(1):38–46.​

      9. Sheybani A, Reitsamer H, Ahmed II. Fluid Dynamics of a Novel Micro-Fistula Implant for the Surgical Treatment of Glaucoma. Invest Ophthalmol Vis Sci. 2015 Jul;56(8):4789-95.​

         

      SE-XEN-240015 v. 1.0 December 2024