The SOLX® Gold Shunt - IOP Reduction without a BLEB
The SOLX® Gold Shunt is the first biocompatible, 24-karat gold implant that uses the eye's natural pressure differential (uveal scleral outflow) to reduce Intraocular Pressure (IOP) without a bleb. It is approximately 3 mm wide, 6 mm long; it is about the thickness of a human hair. The Gold Shunt's thin structure is designed for implantation through a single micro-incision. It contains numerous micro-channels that bridge the anterior chamber and the suprachoroidal space, controlling aqueous outflow to reduce IOP. The shunt is virtually undetectable by the patient and is intended to last indefinitely.
The SOLX® Gold Shunt GMS Plus is the only model currently available. The outside dimensions are the same as the original Gold Shunt, however, the internal architecture incorporates a greater outflow facility (i.e., lower flow resistance) that provides lower intra-ocular pressure (IOP) with minimal glaucoma medications.
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| Figure 1. The complete SOLX GMS Plus device |
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| Figure 2. Illustration of the internal architecture in an exploded view of the device, highlighting flow resistance channels. The flow resistance is now 40 times greater than in previous gold shunt models. |
IOP reduction in the GMS Plus is determined by a combination of the pressure differential between the anterior chamber (AC) and the suprachoroidal space (SCS), and the flow resistance of the gold shunt that is used to communicate these two spaces. The pressure differential between the spaces has been demonstrated to be consistent across the full range of IOP1.
The revised internal architecture of the device does not present a significant change in overall design, components, method of manufacture, or intended use of the device, nor does it constitute a change in design, material, composition, or manufacturing process that would significantly affect the safety and effectiveness of the device.
Effectiveness: IOP reduction of 45.6% with SOLX® Gold Shunt GMS Plus
