EX-PRESS® Device in Clinical Practice New York September, 2011

Marlene R. Moster MDProfessor of Ophthalmology

Thomas Jefferson School of MedicineWills 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 conjunctivaVirgin eyes with deep chambers and open angles that have failed medications and SLT/ALT and need surgical glaucoma careEyes that have had failed triples but with enough room temporal or nasal to put in the

EX-PRESS® DevicePatients 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 iridectomyWith 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. AccountantIOP 24 in spite of maximum tolerated medical therapy and SLT laser-12.0 myopepseudophakic

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80 y.o homemaker

Had cataract surgery with a 3 piece IOL 19 years ago

Vision always 20/20, PseudoexfoliationIOP always normal, one drop of timololPresented with decreased vision of 20/400IOP of 40mmHgLens 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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Oh boy!

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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 armamentariumClinical studies have shown that it is safe and effective1 If there is scarring, it can be needledOne 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. EXP11707SK

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THANK YOU

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