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

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. EXP11707SK. EX-PRESS® Device Brief Statement.

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

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  1. 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 EXP11707SK

  2. 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. EXP11707SK

  3. A move toward standardization EXP11707SK

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  6. 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 EXP11707SK

  7. EX-PRESS® Device EXP11707SK

  8. 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 EXP11707SK

  9. EX-PRESS® Device Challenge • 58 yo. Accountant • IOP 24 in spite of maximum tolerated medical therapy and SLT laser • -12.0 myope • pseudophakic EXP11707SK

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  11. 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 EXP11707SK

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  14. OOPS! What can go wrong? EXP11707SK

  15. OOPS! What can go wrong? EXP11707SK

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  17. Oh boy! EXP11707SK

  18. Blew the thin area near the needle tract open with iris prolapse ! EXP11707SK

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  20. You always have options, which is why the comfort level with the EX-PRESS® device is so high EXP11707SK

  21. 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. EXP11707SK

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  23. Thank you EXP11707SK

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