EX-PRESS® Device

Report
EX-PRESS® Device in Clinical Practice
New York September, 2011
Marlene R. Moster MD
Professor of Ophthalmology
Thomas Jefferson School of Medicine
Wills Eye Institute Philadelphia, Pa
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EX-PRESS® Device Brief Statement
CAUTION: Federal 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.
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 surgeon should be familiar with the instructions 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.
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A move toward standardization
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Other Considerations
Pseudophakes with temporal incisions and
virgin superior conjunctiva
Virgin eyes with deep chambers and open
angles that have failed medications and SLT/ALT
and need surgical glaucoma care
Eyes that have had failed triples but with
enough room temporal or nasal to put in the
EX-PRESS® Device
Patients who you would rather not put in a tube
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EX-PRESS® Device
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What is the difference?
A trabeculectomy removes a piece of the
cornea/trabecular meshwork which is followed by
an iridectomy
With the EX-PRESS® device, there is no removal of
tissue, and an iridectomy is not necessary
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EX-PRESS® Device Challenge
58 yo. Accountant
IOP 24 in spite of maximum tolerated
medical therapy and SLT laser
-12.0 myope
pseudophakic
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80 y.o homemaker
Had cataract surgery with
a 3 piece IOL 19 years ago
Vision always 20/20, Pseudoexfoliation
IOP always normal, one drop of timolol
Presented with decreased vision of 20/400
IOP of 40mmHg
Lens sinking inferiorly but still in the correct
plane
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OOPS! What can go wrong?
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OOPS! What can go wrong?
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Blew the thin area near the
needle tract open with iris
prolapse !
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You always have options, which is why the
comfort level with the EX-PRESS® device is so
high
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In Summary
The EX-PRESS® device is another good option
in our surgical armamentarium
Clinical studies have shown that it is safe and
effective1
If there is scarring, it can be needled
One can always put in a larger tube down the
road if it should fail
1. P. J. G. Maris, K Ishida, P A Netland. Comparison of Trabeculectomy with Ex-PRESS miniature Glaucoma Device Implanted
Under Scleral Flap. J Glaucoma. 2007 Jan; 16:14-19.
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THANK YOU
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