EX-PRESS ® Glaucoma Filtration Device

Report
Glaucoma Surgery
®
& The EX-PRESS Device
Ike K. Ahmed, MD
EXP11732SK
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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Disclosures
• Consultant (+S)
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Alcon
Allergan
Aquesys
AMO
Carl Zeiss
Clarity
Endooptiks
Eyelight
Glaukos
iScience
Ivantis
Pfizer
Transcend
• Research Grants • Speaker Honoraria (S)
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Alcon®
Allergan
Aquesys
Carl Zeiss
iScience
Merck
Pfizer
SOLX
Visiogen
– New World Medical
Ike K. Ahmed
EXP11732SK
Glaucoma Surgical
Options
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Glaucoma Surgery Trends
• Evolutionary improvements in trabeculectomylike procedures
– Canaloplasty
– EX-PRESS® glaucoma filtration device
• Increased use of long-tube shunts
– Ahmed, Baerveldt glaucoma drainage devices
• New field “Minimally Invasive Glaucoma Surgery
(MIGS)”
– Safe, quick procedures with modest IOP-lowering
– Use at time of cataract surgery
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Ike K. Ahmed, MD
EXP11732SK
Overview of Current MIGS Procedures
Commercialized and in Development
Commercialized
• Trabectome
• ECP
Schlemm’s Canal
Cycloablation
•Not FDA Approved
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•† Trademarks are the property of their respective owner.
Investigational*
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iStent†
Hydrus
ELT
Cypass
Aquesys
Schlemm’s Canal
Suprachoroidal Space
Subconjunctival Space
Ike K. Ahmed, MD
EXP11732SK
Ab-Interno MIGS Pathways
Subconjunctival
Schlemm’s Canal
Suprachoroidal
IOP Drop
More Potent
Moderate
Moderate
Risk
Slightly More
Lowest Risk
Low
Ease of Use
Easy to Perform
+/- Gonio
Somewhat more Difficult
Requires Gonio View
Easiest to Perform
+/- Gonio
Potential
Issues
?Bleb Issues
?Episcleral Healing
?Hypotony
?Uncertainty of
Placement
?EVP Floor
?Distal Outflow Status
?Angle Bleeding
?Variable IOP Drop
?Fibrosis in SCS
Other
Features
Familiarity
Ability to modulate
postop healing
Physiologic
?Titratable
Potential
Ready for Primetime?
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Patient Profiles: New Procedures
Trab-type Procedures
EX-PRESS® Device
• Moderate-advanced disease
• Progressing normal pressure
glaucoma
• Open Angle
• Low IOP target (i.e.,
<13mmHg)
• Intolerant to meds and failed
SLT/ALT
Source: EX-PRESS® glaucoma filtration device package insert
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Ike K. Ahmed, MD
EXP11732SK
Glaucoma Surgery
• Has traditionally been all about efficacy
• Serious safety issues have promoted
evolutionary improvements
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Ike K. Ahmed, MD
EXP11732SK
Evolution of the Guarded Filtration
Procedure
• Wound healing strategies
• Suture tension & laser
suture lysis
• Fornix-based flaps
• Non-penetrating
approaches
• EX-PRESS® glaucoma
filtration device
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Ike K. Ahmed, MD
EXP11732SK
What Differentiates one Filter from
the Next in My Experience
Intraoperative
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AC shallowing
Tissue trauma
Bleeding
Length of procedure
Postoperative
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Hypotony
Shallow/flat AC
Choroidals
Hyphema
Bleb leak
Bleb encapsulation
Bleb dysthesia
IOP control
Visual recovery
Postop interventions
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EX-PRESS® Glaucoma Filtration Device
A Limbal Aqueous Device
• Made of rigid 316LVM stainless steel – same as cardiac
stents
• < 3mm long
• Internal lumen size – 50µm/200µm
• Biocompatible
• MRI of the head is permitted, however not
recommended, in the first two weeks post implantation.
Source: EX-PRESS® glaucoma filtration device package insert
P-50
A Nyska, Y. Glovinsky, M. Belkin, and Y. Epstein. Biocompatibility of the EX-PRESS® miniature glaucoma drainage implant. J
Glaucoma. 2003 Jun; 12(3):275-80
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EX-PRESS® Device = Trabeculectomy
• Potent IOP lowering1
• Requires scleral flap for additional flow control
– Although not as critical
• Requires functioning bleb, control of episcleral
fibrosis
– Conjunctival health a factor
– Wound healing modulation
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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Ike K. Ahmed, MD
EXP11732SK
EX-PRESS® Device > Trabeculectomy
• Quieter eyes in early
postoperative period1
• Avoidance of
intraoperative
malignant glaucoma
or choroidals1
• Reduction of early
postoperative
hypotony1
• No iridectomy
required
• Intraoperative
maintenance of
anterior chamber
• Additional fluidic
restriction (50um
lumen)
• Consistency
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; 16:1419.
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Ike K. Ahmed, MD
EXP11732SK
EX-PRESS® Device Rationale & Transition
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Hit low IOP target1,2
Enhanced predictability1
Minimize tissue disruption
Improved safety1
Quieter postoperative course1
Quicker visual recovery2
Reduction of postop visits2
Improved bleb morphology2
1) Maris PJ et al., J Glaucoma 2007
2) Good TJ, Kahook MY, AJO 2011
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Ike K. Ahmed, MD
EXP11732SK
On-Label Indications (US)
• Open angle glaucoma
• Failed medical and laser/surgical therapy
• Anatomical factors
– Scleral thickness
– Angle anatomy
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Ike K. Ahmed, MD
EXP11732SK
EX-PRESS® Device Technique Pearls
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Anatomical landmarks
Scleral flap design and thickness
Device entry and angulation
Postoperative bleb management
Ike K. Ahmed, MD
EXP11732SK
Surgical Limbal Anatomy
Cornea
Blue-zone
Scleral Spur
Sclera
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AC Entry
Entry should be just at anterior aspect of scleral spur, at
posterior aspect of the limbal blue zone.
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Planning Scleral Flap Position & Size
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Identify Surgical Limbus
Planned entry point for EX-PRESS® Device
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3.5x2.5 mm Scleral Flap
1/2mm anterior gap to prevent excessive device compression
1.0
0.5
1.0
1.0
2.5
3.5
Ensure adequate flap overlap lateral and posterior to EX-PRESS® device
to allow control of aqueous flow
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Enter at anterior scleral spur/posterior blue zone
Parallel to iris plane - aided by rotation of eye downwards
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Parallel to Iris
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Postop Management
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Bleb management
Laser suture lysis
Needling
Steroids
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Ike K. Ahmed, MD
EXP11732SK
EX-PRESS® Glaucoma Filtration Device
• An evolutionary improvement in
trabeculectomy
• Smaller incision, more standardized
• Patient selection is much the same, although
with improvement in safety and
reproducibility, may be slightly broader (earlier
intervention)
• Retains high efficacy
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Ike K. Ahmed, MD
EXP11732SK

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