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The Confidence of Lumenal Control

If you don’t already perform EX-PRESS® Glaucoma Filtration
Device implantations, what’s holding you back?

  I don’t think there is enough data to support it.

Actually, the EX-PRESS® Glaucoma Filtration Device has been implanted more than 125,000 times, and it has been studied extensively. Data shows that EX-PRESS® Glaucoma Filtration Device patients experienced significantly lower IOP rates compared with trabeculectomy patients for up to three years and similar rates at five years.1 They also experienced a reduced need for IOP-lowering medications at all postoperative visits within a five-year study period,1 a more rapid recovery2 and less early postoperative hypotony and choroidal effusions.2

   I’m not sure about how reimbursement works.

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

   I have concerns over biocompatibility and scarring.
   I’m worried that the device will interfere with MRIs.

Actually, the EX-PRESS® Glaucoma Filtration Device labeling states MRI of the head is permitted, though not recommended, in the first two weeks post implantation.4

   I don’t have any experience with the procedure.

Good news! While the EX-PRESS® Glaucoma Filtration Device is revolutionizing glaucoma surgery, it doesn’t require as much of a change for surgeons who are experienced with performing the trabeculectomy as you might expect. In fact, there are a number of similarities between the two procedures.

1. de Jong L, Lafuma A, Aguadé AS, Berdeaux G. Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma. Clin Ophthalmol. 2011;5:527-533.

2. Maris P, et al. Comparison of trabeculectomy with EX-PRESS miniature glaucoma device implanted under scleral flap. J Glaucoma. Jan 2007;16(1):14-19.

*Not all of the studies above involved the currently marketed P50 or P200 models. However, those models have similar performance to earlier models, which were included in some of these studies. See Directions for Use.

1. de Jong L, Lafuma A, Aguadé AS, Berdeaux G. Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma. Clin Ophthalmol. 2011;5:527-533.

3. Nyska A, et al. Biocompatibility of the EX-PRESS miniature glaucoma drainage implant. J Glaucoma. 2003;12(3):275-280.

*Not all of the studies above involved the currently marketed P50 or P200 models. However, those models have similar performance to earlier models, which were included in some of these studies. See Directions for Use.

4. EX-PRESS® Glaucoma Filtration Device Directions for Use.

*Not all of the studies above involved the currently marketed P50 or P200 models. However, those models have similar performance to earlier models, which were included in some of these studies. See Directions for Use.

Dynamic, Six-Point Engineering

Thanks to proven six-point engineering — based on extensive research and development — the EX-PRESS® Glaucoma Filtration Device’s Lumenal Control optimizes flow dynamics in ways a trabeculectomy can’t. Standardizing the lumenal structure through which aqueous humor flows yields a consistent, more predictable filtration.

See the innovative six-point engineering up close.

Tour the innovation that is six-point Lumenal Control.

See the innovative six-point engineering up close.

Regulated IOP Means More Control

One of the key differences between EX-PRESS® Glaucoma Filtration Device implantation and the trabeculectomy is that the EX-PRESS® Glaucoma Filtration Device procedure offers less variability in anterior chamber depth.

During a trabeculectomy, the anterior chamber can flatten or collapse before closure of the scleral flap. However, the anterior chamber usually remains well-formed throughout the EX-PRESS® Glaucoma Filtration Device implantation procedure, decreasing potential for complications. The device’s lumen provides a standardized opening for aqueous humor flow while also providing some resistance, which appears to add further stability to the anterior chamber during surgery and the early post-op period.

Enjoy the Benefits of Lumenal Control

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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.