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Safety and Biocompatibility

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.

Designed for Patient Outcomes

The EX-PRESS® Glaucoma Filtration Device is biocompatible when placed under a scleral flap in the human eye. Not only is implantation of the device less invasive compared with a trabeculectomy, but the surgical-grade stainless steel it’s made with has a history of over 30 years of biocompatibility.

Proven BiocompatibilitySee more

Surgical-grade stainless steel has been in use in ORs for more than 30 years. In the EX-PRESS® Glaucoma Filtration Device, it has been shown to produce:

  • Minimal inflammation and fibrin formation1
  • Minimal scarring reactions1

MRI SafetySee more

The biocompatibility of the EX-PRESS® Glaucoma Filtration Device also extends to MRIs. The EX-PRESS® Glaucoma Filtration Device labeling states MRI of the head is permitted, however not recommended, in the first two weeks post implantation.2

Additionally, MRI images of the orbit and brain were evaluated to determine if the EX-PRESS® Glaucoma Filtration Device affected imaging of the optic nerve and visual pathways. The study concluded that:

  • Brain imaging was good quality3
  • Optic nerve imaging was sufficient for radiologic evaluation3

Post-op OutcomesSee more

Because the EX-PRESS® Glaucoma Filtration Device’s implantation doesn’t require invasive procedures like sclerectomy and iridectomy, patients can expect a more rapid recovery.4 And because the device promotes controlled drainage, patients usually experience lower rates of hypotony.4

There’s also a significant reduction in the risk of:

  • Inflammation
  • Pigment release
  • Bleeding from the iris
  • Vitreous prolapse

Fewer complications and a more predictable healing process mean fewer post-op visits.5

Percentage of Patients on Intraocular Pressure Medications

Percentage of glaucoma patients on IOP medications after glaucoma filtration surgery.

The EX-PRESS® Glaucoma Filtration Device reduces the need for IOP-lowering medications at all postoperative visits up to five years through surgery.6

Patients' Intraocular Pressure Before and After Surgery

Glaucoma filtration patients' IOP before and after surgery.

In a five-year study, EX-PRESS® Glaucoma Filtration Device patients experienced significantly lower IOP rates compared with trabeculectomy patients for up to three years, with no significant difference at years four and five.6

Complications and Adverse EventsSee more

Clinical trials have indicated some adverse events with an occurrence rate above 5%. These complications and adverse events associated with the EX-PRESS® Glaucoma Filtration Device include:2

  • Glaucoma filtration surgery
  • Device removal
  • Revision of bleb without antimetabolites
  • Device-Iris touch
  • Hyphema <2 mm
  • Shallow anterior chamber
  • Hypotony
  • Revision of bleb with antimetabolites
  • Tenon cyst
  • Corneal complication
  • Anterior chamber reformation
  • Device exposure

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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.