Transcript Clinical Experience With the EX-PRESS® Glaucoma Filtration

Clinical Experience With the
EX-PRESS® Glaucoma Filtration
Device
Thomas W. Samuelson, M.D.
Minnesota Eye Consultants
Minneapolis
EXP11748SK
®
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
EXP11729SK
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.
EXP11748SK
EXP11748SK
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)
EXP11748SK
Text
Journal of Glaucoma, April 2005
EXP11748SK
®
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
EXP11748SK
®
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
Source: EX-PRESS® glaucoma filtration device package insert
EXP11748SK
®
EX-PRESS
Device Guarded
Filtration Procedure
The same sclerostomy every time...
EXP11748SK
®
EX-PRESS
Guarded Filtration
Procedure
Standardized sclerostomy
Not Standardized trabeculectomy!
But...
Safer,
More elegant,
More reproducible,
Less invasive
EXP11748SK
video two
EXP11748SK
video three
EXP11748SK
Safety Improvements vs Efficacy Improvements
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
EXP11748SK
EXP11748SK
EXP11748SK
Why Not Tubes?
I love tubes...
But not as my first surgery in most
patients
EXP11748SK
Postop
Complications
Tube 34%
Trab 57%
EXP11748SK
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 lysis
EXP11748SK
We must reduce the
stagnation in glaucoma
surgery innovation!
EXP11748SK
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)
EXP11748SK
We spend a fortune meticulously
documenting disease progression
Visual fields, disc imaging, NFL imaging, angle imaging
EXP11748SK
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!
EXP11748SK
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!
EXP11748SK
• Thank-you so much!
EXP11748SK