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Compatibility and durability of the gel stent material
Vanessa Vera1, Arsham Sheybani2, William Wustenberg3
1Glaucoma Department, Unidad Oftalmológica de Caracas, Miranda, Venezuela.
Expert Review of Medical Devices
|May 26, 2022
Summary
The XEN Gel Stent, made of gelatin, offers a durable and biocompatible solution for creating a permanent connection to reduce eye pressure. Real-world data supports its safety and effectiveness in glaucoma treatment.
Area of Science:
- Ophthalmology
- Biomaterials Science
Background:
- The XEN Gel Stent is a medical device utilizing gelatin, a material known for its firmness and tissue-conforming properties.
- It is designed to establish a permanent outflow pathway from the anterior chamber to the subconjunctival space.
Purpose of the Study:
- To evaluate the biocompatibility and durability of the XEN Gel Stent material.
- To review real-world clinical experience with the XEN Gel Stent.
Main Methods:
- Review of preclinical validation testing data.
- Analysis of published literature on study outcomes.
- Compilation and discussion of surgeon experiences.
Main Results:
- Preclinical testing indicates acceptable biocompatibility and durability.
- Published literature and surgeon experiences corroborate the safety profile.
- The XEN Gel Stent functions as a stable, nondegradable, permanent implant.
Conclusions:
- The XEN Gel Stent demonstrates a favorable biocompatibility and durability profile.
- The device provides a reliable, long-term solution for managing intraocular pressure.
- Combined evidence supports the XEN Gel Stent as a safe and effective treatment option.
