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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®

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Presentation on theme: "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®"— Presentation transcript:

1 EXP11732SK

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 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. · 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. · This device is for single use only. · MRI of the head is permitted, however not recommended, in the first two weeks post implantation. · 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

3 Disclosures Consultant (+S) 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) Speaker Honoraria (S) – New World Medical EXP11732SK

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5 Glaucoma Surgery Trends Evolutionary improvements in trabeculectomy- like procedures Evolutionary improvements in trabeculectomy- like procedures – Canaloplasty – EX-PRESS ® glaucoma filtration device Increased use of long-tube shunts Increased use of long-tube shunts – Ahmed, Baerveldt glaucoma drainage devices New field “Minimally Invasive Glaucoma Surgery (MIGS)” New field “Minimally Invasive Glaucoma Surgery (MIGS)” – Safe, quick procedures with modest IOP-lowering – Use at time of cataract surgery Ike K. Ahmed, MD 5 EXP11732SK

6 Overview of Current MIGS Procedures Commercialized and in Development Commercialized Trabectome ECP Investigational* iStent † Hydrus ELT Cypass Aquesys Ike K. Ahmed, MD Schlemm’s Canal Suprachoroidal Space Subconjunctival Space 6 Cycloablation Not FDA Approved † Trademarks are the property of their respective owner. EXP11732SK

7 SubconjunctivalSchlemm’s CanalSuprachoroidal IOP Drop More PotentModerate Risk Slightly MoreLowest RiskLow 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 Ab-Interno MIGS Pathways Ready for Primetime? EXP11732SK

8 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 Ike K. Ahmed, MD 8 EXP11732SK Source: EX-PRESS® glaucoma filtration device package insert

9 Glaucoma Surgery Has traditionally been all about efficacy Has traditionally been all about efficacy Serious safety issues have promoted evolutionary improvements Serious safety issues have promoted evolutionary improvements Ike K. Ahmed, MD 9 EXP11732SK

10 Evolution of the Guarded Filtration Procedure Wound healing strategies Wound healing strategies Suture tension & laser suture lysis Suture tension & laser suture lysis Fornix-based flaps Fornix-based flaps Non-penetrating approaches Non-penetrating approaches EX-PRESS ® glaucoma filtration device EX-PRESS ® glaucoma filtration device Ike K. Ahmed, MD 10 EXP11732SK

11 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

12 EX-PRESS ® Glaucoma Filtration Device A Limbal Aqueous Device Made of rigid 316LVM stainless steel – same as cardiac stents Made of rigid 316LVM stainless steel – same as cardiac stents < 3mm long < 3mm long Internal lumen size – 50µm/200µm Internal lumen size – 50µm/200µm Biocompatible Biocompatible MRI of the head is permitted, however not recommended, in the first two weeks post implantation. MRI of the head is permitted, however not recommended, in the first two weeks post implantation. P-50 EXP11732SK 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 Jun; 12(3):275-80

13 EX-PRESS ® Device = Trabeculectomy Potent IOP lowering 1 Potent IOP lowering 1 Requires scleral flap for additional flow control Requires scleral flap for additional flow control – Although not as critical Requires functioning bleb, control of episcleral fibrosis Requires functioning bleb, control of episcleral fibrosis – Conjunctival health a factor – Wound healing modulation Ike K. Ahmed, MD 13 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 Jan; 16: EXP11732SK

14 EX-PRESS ® Device > Trabeculectomy No iridectomy required No iridectomy required Intraoperative maintenance of anterior chamber Intraoperative maintenance of anterior chamber Additional fluidic restriction (50um lumen) Additional fluidic restriction (50um lumen) Consistency Consistency Quieter eyes in early postoperative period 1 Avoidance of intraoperative malignant glaucoma or choroidals 1 Reduction of early postoperative hypotony 1 Ike K. Ahmed, MD 14 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 Jan; 16: EXP11732SK

15 EX-PRESS ® Device Rationale & Transition Hit low IOP target 1,2 Hit low IOP target 1,2 Enhanced predictability 1 Enhanced predictability 1 Minimize tissue disruption Minimize tissue disruption Improved safety 1 Improved safety 1 Quieter postoperative course 1 Quieter postoperative course 1 Quicker visual recovery 2 Quicker visual recovery 2 Reduction of postop visits 2 Reduction of postop visits 2 Improved bleb morphology 2 Improved bleb morphology 2 Ike K. Ahmed, MD 15 1) Maris PJ et al., J Glaucoma ) Good TJ, Kahook MY, AJO 2011 EXP11732SK

16 On-Label Indications (US) Open angle glaucoma Open angle glaucoma Failed medical and laser/surgical therapy Failed medical and laser/surgical therapy Anatomical factors Anatomical factors – Scleral thickness – Angle anatomy Ike K. Ahmed, MD 16 EXP11732SK

17 EX-PRESS ® Device Technique Pearls Anatomical landmarks Anatomical landmarks Scleral flap design and thickness Scleral flap design and thickness Device entry and angulation Device entry and angulation Postoperative bleb management Postoperative bleb management Ike K. Ahmed, MD EXP11732SK

18 Scleral Spur Sclera Blue-zone Cornea Surgical Limbal Anatomy EXP11732SK

19 AC Entry Entry should be just at anterior aspect of scleral spur, at posterior aspect of the limbal blue zone. EXP11732SK

20 Planning Scleral Flap Position & Size EXP11732SK

21 Identify Surgical Limbus Planned entry point for EX-PRESS® Device EXP11732SK

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23 3.5x2.5 mm Scleral Flap Ensure adequate flap overlap lateral and posterior to EX-PRESS® device to allow control of aqueous flow 1/2mm anterior gap to prevent excessive device compression EXP11732SK

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25 Enter at anterior scleral spur/posterior blue zone Parallel to iris plane - aided by rotation of eye downwards EXP11732SK

26 Parallel to Iris EXP11732SK

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28 Postop Management Bleb management Bleb management Laser suture lysis Laser suture lysis Needling Needling Steroids Steroids Ike K. Ahmed, MD 28 EXP11732SK

29 EX-PRESS ® Glaucoma Filtration Device An evolutionary improvement in trabeculectomy An evolutionary improvement in trabeculectomy Smaller incision, more standardized Smaller incision, more standardized Patient selection is much the same, although with improvement in safety and reproducibility, may be slightly broader (earlier intervention) Patient selection is much the same, although with improvement in safety and reproducibility, may be slightly broader (earlier intervention) Retains high efficacy Retains high efficacy Ike K. Ahmed, MD 29 EXP11732SK


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