Clinical Experience With theEX-PRESS® Glaucoma Filtration

Device

Thomas W. Samuelson, M.D.Minnesota Eye Consultants

Minneapolis

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EX-PRESS® Device Brief Statement

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.

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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Not always a disciple...

~ 2002

• Participated in certification course

• Never did a case...

• “The EX-PRESS® Device is Glaucoma Roulette”

~2007-2009

• Willing to take another look

2009 - 2011

• “Love the EX-PRESS® Device!”

• (Note FDA approval Mar 02, JOG paper under scleral flap April 2005)

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Text

Journal of Glaucoma, April 2005EXP11748SK

EX-PRESS® Glaucoma Filtration Device Procedure

Minimally invasive

Little if any shallowing of AC

No need to release traction suture

Less “open eye” risk: less SCH vulnerable

VIDEO 1

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EX-PRESS® Device Guarded Filtration Procedure

Minimally invasive...

No risk of iris prolapse

No risk of bleeding from ciliary body

More wound control

Less Induced Astigmatism

More posterior flow

EXP11748SKSource: EX-PRESS® glaucoma filtration device package insert

EX-PRESS® Device Guarded Filtration Procedure

The same sclerostomy every time...

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EX-PRESS® Guarded Filtration Procedure

Standardized sclerostomy

Not Standardized trabeculectomy!

But...Safer, More elegant,More reproducible,Less invasive

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video two

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video three

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EX-PRESS® device does not have to get better results to be safer/more controlled and more elegant.

A better experience for surgeon and, more importantly, for the patient

Safety Improvements vs Efficacy Improvements

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Why Not Tubes?

I love tubes...

But not as my first surgery in most patients

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Postop Complication

sTube 34%Trab 57%

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Incremental Improvements

The EX-PRESS® device is not the final answer in our quest for a standardized glaucoma operation

It is a good next step

Surgeons will make it better

There is a learning curve for post op care

Diffuse massage v focal massage

Earlier suture lysisEXP11748SK

We must reduce the stagnation in

glaucoma surgery innovation!

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What about the cost?

•Dear Patient ...

•“I am sorry. Society can’t afford to improve on the glaucoma surgery of 1980’s”

•(antimetabolite filtering era)

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We spend a fortune meticulously documenting disease progression

Visual fields, disc imaging, NFL imaging, angle imaging

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Our advances in imaging and in pharma are fabulous. But where is the investment in

our surgical treatment options?

Enough already, We need to move our surgical procedure forward!

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We have not invested in the surgical treatment of Glaucoma This is our time!

For the first time we have industry R & D resources focused on glaucoma. Some very smart people looking to help us!• If we ignore them, if we are satisfied with 1980s surgical methods, they will go elsewhere with their resources!

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•Thank-you so much!

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