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Frequently Asked Questions

Which of my patients are candidates for surgery with the EX-PRESS® Glaucoma Filtration Device? See more

The EX-PRESS® Glaucoma Filtration Device is indicated for open-angle glaucoma patients for whom medication and other conventional surgical treatments have failed, including patients who have previously undergone unsuccessful trabeculectomies.

How does the device's efficacy compare to that of the trabeculectomy? See more

Clinical studies have shown that the EX-PRESS® Glaucoma Filtration Device's implantation procedure effectively maintains steady pressure in the anterior chamber during surgery, and the device's post-op IOP-lowering capability is comparable to the trabeculectomy.1 EX-PRESS® Glaucoma Filtration Device patients also enjoy a decrease in the need for IOP-lowering medication in the long-term, compared with trabeculectomy patients.2

What is Lumenal Control? See more

The Lumenal Control of the EX-PRESS® Glaucoma Filtration Device was developed through extensive research and realized through precise six-point engineering. By filtering aqueous humor flow from the anterior chamber into a subconjunctival bleb through a standardized lumen, the EX-PRESS® Glaucoma Filtration Device yields predictable, repeatable results. Learn more about Lumenal Control.

How does the device's complications rate compare to the trabeculectomy? See more

Not only do EX-PRESS® Glaucoma Filtration device patients experience lower rates of hypotony and choroidal effusion versus trabeculectomy patients,1 but they also average faster recovery rates and fewer post-op visits.3 Read more about the EX-PRESS® Glaucoma Device safety profile.

Have physicians implanting the EX-PRESS® Glaucoma Filtration Device reported any occurrences of corneal decompensation? See more

Corneal decompensation is not an adverse event generally associated with the EX-PRESS® Glaucoma Filtration Device.

How does the EX-PRESS® Glaucoma Filtration Device control postoperative intraocular pressure?See more

Like the trabeculectomy, the EX-PRESS® Glaucoma Filtration Device diverts aqueous humor flow from the anterior chamber to a bleb in the subconjunctival space. Where the methods differ is in the EX-PRESS® Glaucoma Filtration Device's standardized lumen — which maintains uniform aqueous humor outflow — and the dual inlet, which allows for continued drainage even in the event of blockage of the tip.

Is the EX-PRESS® Glaucoma Filtration Device biocompatible?See more

Yes. The device is made of surgical-grade stainless steel, a biocompatible material that has been in use in ORs for more than 30 years. The device has been shown to produce minimal inflammation and scarring.4

Can a patient with an implanted EX-PRESS® Glaucoma Filtration Device safely undergo an MRI?See more

The EX-PRESS® Glaucoma Filtration Device labeling states MRI of the head is permitted, though not recommended, in the first two weeks post implantation.5

Do surgeons who implant the EX-PRESS® Glaucoma Filtration Device receive reimbursement?See more

Use of the EX-PRESS® Glaucoma Filtration Device is covered by Medicare, as well as most commercial payers.

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See Important Product Information for:
EX-PRESS® Glaucoma Filtration Device +

EX-PRESS® Glaucoma Filtration Device

CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.

GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor’s discretion.

CLINICAL STUDY INFORMATION: A clinical study was performed with the EX-PRESS® Glaucoma Filtration Device versions R-30 and R-50. The study was a prospective, open-label multi-center study of 113 open angle glaucoma patients with a follow-up period of one year. Results indicated an 80.4% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP reduction greater than 20% from baseline with or without medications. Results indicated a 75.9% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP of less than 21 mmHg with or without medications. The mean IOP reduction at one year was 33.8%. The percentage reduction from baseline was greater than 28% for the R-30 version and greater than 40% for the R-50 version.

The overall average number of glaucoma medications dropped significantly from 1.55 pre-operative to 0.52 medications at one-year postoperative.

The clinical study was not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor’s discretion. The most commonly reported adverse events included the need for further filtering surgery, device explantation, bleb revision and iris touch. Reasons for device explantation included flat anterior chamber with hypotony, device exposure from erosion, and poor efficacy. Other adverse events such as, but not limited to, corneal and retinal complications, uveitis, and significant reduction in visual acuity, may occur as well.

CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist:

  • Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
  • Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
  • Patients diagnosed with angle closure glaucoma.

WARNINGS/PRECAUTIONS: The use of this device is contraindicated if one or more of the following conditions exist:

  • The surgeon should be familiar with the directions for use.
  • The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised.
  • This device is for single use only.
  • MRI of the head is permitted, however not recommended, in the first two weeks post implantation.

ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.

EX-PRESS® Glaucoma Filtration Device

CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.

GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor’s discretion.

CLINICAL STUDY INFORMATION: A clinical study was performed with the EX-PRESS® Glaucoma Filtration Device versions R-30 and R-50. The study was a prospective, open-label multi-center study of 113 open angle glaucoma patients with a follow-up period of one year. Results indicated an 80.4% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP reduction greater than 20% from baseline with or without medications. Results indicated a 75.9% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP of less than 21 mmHg with or without medications. The mean IOP reduction at one year was 33.8%. The percentage reduction from baseline was greater than 28% for the R-30 version and greater than 40% for the R-50 version.

The overall average number of glaucoma medications dropped significantly from 1.55 pre-operative to 0.52 medications at one-year postoperative.

The clinical study was not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor’s discretion. The most commonly reported adverse events included the need for further filtering surgery, device explantation, bleb revision and iris touch. Reasons for device explantation included flat anterior chamber with hypotony, device exposure from erosion, and poor efficacy. Other adverse events such as, but not limited to, corneal and retinal complications, uveitis, and significant reduction in visual acuity, may occur as well.

CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist:

  • Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
  • Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
  • Patients diagnosed with angle closure glaucoma.

WARNINGS/PRECAUTIONS: The use of this device is contraindicated if one or more of the following conditions exist:

  • The surgeon should be familiar with the directions for use.
  • The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised.
  • This device is for single use only.
  • MRI of the head is permitted, however not recommended, in the first two weeks post implantation.

ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.