EXP11732SK. EX-PRESS® Device Brief Statement CAUTION: Federal law restricts this device to sale by...
-
Upload
bernardo-leuty -
Category
Documents
-
view
225 -
download
1
Transcript of EXP11732SK. EX-PRESS® Device Brief Statement CAUTION: Federal law restricts this device to sale by...
Glaucoma Surgery& The EX-PRESS® Device
Ike K. Ahmed, MDEXP11732SK
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.
EXP11706SK EXP11732SK
Disclosures• Consultant (+S)
– Alcon– Allergan– Aquesys– AMO– Carl Zeiss– Clarity– Endooptiks– Eyelight– Glaukos– iScience– Ivantis– Pfizer– Transcend
• Research Grants– Alcon®– Allergan– Aquesys– Carl Zeiss– iScience– Merck– Pfizer– SOLX– Visiogen
Ike K. Ahmed
• Speaker Honoraria (S)– New World Medical
EXP11732SK
Glaucoma Surgical Options
EXP11732SK
Ike K. Ahmed, MD5
Glaucoma Surgery Trends• Evolutionary improvements in trabeculectomy-
like 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
EXP11732SK
Ike K. Ahmed, MD
Overview of Current MIGS Procedures Commercialized and in Development
Commercialized• Trabectome
• ECP
Investigational*• iStent†
• Hydrus• ELT• Cypass• Aquesys
Schlemm’s Canal
Schlemm’s Canal
Suprachoroidal Space
Subconjunctival Space
6
Cycloablation
•Not FDA Approved•† Trademarks are the property of their respective owner. EXP11732SK
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 DifficultRequires 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
FamiliarityAbility to modulate
postop healingPhysiologic?Titratable Potential
Ab-Interno MIGS Pathways
Ready for Primetime?EXP11732SK
Ike K. Ahmed, MD8
Patient Profiles: New ProceduresTrab-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
EXP11732SKSource: EX-PRESS® glaucoma filtration device package insert
Ike K. Ahmed, MD9
Glaucoma Surgery• Has traditionally been all about efficacy• Serious safety issues have promoted
evolutionary improvements
EXP11732SK
Ike K. Ahmed, MD10
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
Enhanced SafetyPredictabilityMaintain efficacy
EXP11732SK
What Differentiates one Filter from the Next in My Experience
Intraoperative• AC shallowing• Tissue trauma• Bleeding• Length of procedure
Postoperative• Hypotony• Shallow/flat AC• Choroidals• Hyphema• Bleb leak• Bleb encapsulation• Bleb dysthesia• IOP control• Visual recovery• Postop interventions
EXP11732SK
EX-PRESS® Glaucoma Filtration DeviceA 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.
P-50EXP11732SK
Source: EX-PRESS® glaucoma filtration device package insert
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
Ike K. Ahmed, MD13
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.
EXP11732SK
Ike K. Ahmed, MD14
EX-PRESS® Device > Trabeculectomy• No iridectomy
required• Intraoperative
maintenance of anterior chamber
• Additional fluidic restriction (50um lumen)
• Consistency
• Quieter eyes in early postoperative period1
• Avoidance of intraoperative malignant glaucoma or choroidals1
• Reduction of early postoperative hypotony1
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.
EXP11732SK
Ike K. Ahmed, MD15
EX-PRESS® Device Rationale & Transition
• 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 20072) Good TJ, Kahook MY, AJO 2011
EXP11732SK
Ike K. Ahmed, MD16
On-Label Indications (US)• Open angle glaucoma• Failed medical and laser/surgical therapy
• Anatomical factors– Scleral thickness– Angle anatomy
EXP11732SK
Ike K. Ahmed, MD
EX-PRESS® Device Technique Pearls
• Anatomical landmarks• Scleral flap design and thickness• Device entry and angulation• Postoperative bleb management
EXP11732SK
Scleral Spur
Sclera
Blue-zone
Cornea
Surgical Limbal Anatomy
EXP11732SK
AC Entry
Entry should be just at anterior aspect of scleral spur, at posterior aspect of the limbal blue zone.
EXP11732SK
Planning Scleral Flap Position & Size
EXP11732SK
Identify Surgical Limbus
Planned entry point for EX-PRESS® DeviceEXP11732SK
EXP11732SK
3.5x2.5 mm Scleral Flap
Ensure adequate flap overlap lateral and posterior to EX-PRESS® deviceto allow control of aqueous flow
1/2mm anterior gap to prevent excessive device compression
3.5
2.5
1.0
1.0
1.0
0.5
EXP11732SK
EXP11732SK
Enter at anterior scleral spur/posterior blue zoneParallel to iris plane - aided by rotation of eye downwards
EXP11732SK
Parallel to Iris
EXP11732SK
EXP11732SK
Ike K. Ahmed, MD28
Postop Management• Bleb management• Laser suture lysis• Needling• Steroids
EXP11732SK
Ike K. Ahmed, MD29
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
EXP11732SK