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The Ex-Press™ Miniature Glaucoma Implant is intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.

The Ex-PRESS™ Miniature Glaucoma Implant device is a stainless steel tube with a blunt needle shaped penetrating tip at one end and a flat, angled flange at the opposite (distal) end. The device is 2.96mm in length and 0.4mm in diameter. The device consists of a tube whose purpose is to capture aqueous fluid from the anterior chamber of the eve and transport the fluid to the distal end and out of the device from which the fluid then moves into a conjunctival bleb. There are three transverse reserve openings near the proximal end of the device to serve as ports for aqueous fluid in case of occlusion of the primary opening. The flange at the distal end of the device serves as a reservoir and prevents intrusion into the eye. The spur along the bottom of the device prevents extrusion of the device and serves as an anchor. The material of the device is a medical grade stainless steel composition similar in characteristics to other medical implant devices for different indications for use. The device has a stainless steel wire embedded in the tube transverse to the shaft. The purpose of the wire is to restrict the flow passing through the tube. The device drains aqueous humor from the anterior chamber to relieve excessive intraocular pressure associated with glaucoma. The devices available are the R-30 and R-50 versions that represent different flow characteristics created by different wire diameters welded inside the device. The higher the R- number, the lower the resistance of the device to flow.

Here's a summary of the acceptance criteria and study details for the Ex-PRESS™ Miniature Glaucoma Implant, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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