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Transcript of Válvulas Ahmed modelos.
New World Medical, Inc. (NWMI) is a high tech medical device company whose goal is to help humanity lead a better life through improved technology and innovation. Presently NWMI’s focus is in the areas of ophthalmology, neuro-surgery, urology and rapid medical diagnostic tests such as, the detection of HIV.
The Ahmed Glaucoma Valve has been successfully demonstrated to work in all types of glaucoma cases, particularly neovascular, congenital and uvietic glaucoma.
New World Medical, Inc. manufactures and markets its own products. In the U.S. domestic market NWMI distributes its products through a team of sales representatives. In the international market the company has more than 35 exclusive distributors around the world. Along with its own products, NWMI is licensed as a tissue bank, selling human tissue such as sclera and pericardium.
The active R & D division of NWMI is intensely involved in developing new products through collaborations with a number of renowned medical universities and individual doctors, in the U.S. and abroad. These partnerships allow NWMI to develop products through a fi rst hand involvement in the medical device industry. Omar Ahmed has recently joined as Vice President, Director and COO of NWMI.
New World Medical Inc. was founded by Dr. A. Mateen Ahmed. Dr. Ahmed is also the President, CEO and the Chairman of the Board of Directors for the company. The vision of Dr. Ahmed and NWMI is to help the lives of people around the world. This has earned the company many accolades, including the “Have a Heart, International Goodwill and Understanding Award” given by Soroptimist International.
Mechanics of the Ahmed™ Glaucoma Valve
Venturi-Flo™The Venturi™ Effect
To reduce internal friction within the valve system, the Ahmed™ Glaucoma Valve (AGV™) utilizes a speciallydesigned, tapered trapezoidal chamber to create a Ven-turi effect to help aqueous fl ow through the device. As demonstrated by Bernoulli’s equation of hydrodynamic principle, the inlet velocity of aqueous entering the larger port of the Venturi chamber increases signifi cantly as it exits the smaller outlet port of the tapered chamber. In an AGV™ this increased exit velocity greatly helps in evacuating aqueous from the valve, thereby helping to reduce valve friction.
Non-Obstructive,Self-Regulating Mechanism
The Ahmed™ Glaucoma Valve has no obstruction in its path of fl uid fl ow. For the fl ow to be non-obstructive, a particle large enough to pass through the lumen of the tube, will easily pass through a much larger opening of the Venturi-Flow™ chamber. The elastic membranes help to regulate fl uid fl ow at all times, consistently by chang-ing their shape. The tension on these membranes is re-sponsible for reducing hypotony.
Fluid fl owing into section 1 = Fluid fl owing out of section 2
Section 1 P1
Section 2 P2 V2
V1
Product Index
Model Product
FP7 ................... Ahmed™ Glaucoma Valve Flexible Plate™
S2 ..................... Ahmed™ Glaucoma Valve
FP8 ................... Ahmed™ Glaucoma Valve Flexible Plate™ (Pediatric Size)
S3 ..................... Ahmed™ Glaucoma Valve (Pediatric Size)
FX1 ................... Ahmed™ Glaucoma Valve Flexible Bi-Plate™
B1 .................... Ahmed™ Glaucoma Valve Bi-Plate™
FX4 ................... Non-Valved Flexible Plate™
B4 .................... Non-Valved Plate
PC ..................... Pars Plana Clip™
TE ..................... Tube Extender™
Model Product
PC7 ................... Ahmed™ Glaucoma Valve Flexible Plate™ FP7 with Pars Plana Clip™
PC8 ................... Ahmed™ Glaucoma Valve Flexible Plate™ FP8 with Pars Plana Clip™
PS2 ................... Ahmed™ Glaucoma Valve S2 with Pars Plana Clip™
PS3 ................... Ahmed™ Glaucoma Valve S3 with Pars Plana Clip™
TI ...................... Tube Inserter™
Tissue
TSH ................... Sclera Hydrated
TPH ................... Pericardium Hydrated
TPD ................... Pericardium Freeze-Dried
Product Index
• Made of medical grade silicone
• Immediate reduction of intraocular pressure
• Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse
• Implanted in a true, single-stage procedure
• Tapered profi le for easy insertion
• Silicone plate
• Aqueous percolation holes
• Thinner Plate
Model FP7Ahmed™ Glaucoma Valve Flexible Plate™
Ordering Info:
Model: FP7 - Ahmed™ Glaucoma Valve
Materials:
Valved Plate Body: Medical Grade SiliconeDrainage Tube: Medical Grade SiliconeValve: Medical Grade Silicone, Elastomer Membrane
Nominal Specs:
Thickness: 0.9 mmWidth: 13.00 mmLength: 16.00 mmSurface Area: 184.00 mm2
Tube Length: 25.00 mmTube Inner Diameter: 0.305 mmTube Outer Diameter: 0.635 mm
FP7
FP7 Surgical ProcedureStep 1 Step 2 Step 3 Step 4
Step 5 Step 6 Step 7 Step 8
The steps illustrated here are
intended as a guideline only, and do
not represent recommended treat-
ment for any particular patient.
The use of any specific surgical
technique or maneuver is at the
sole discretion of the surgeon.
Surgeons should be familiar with
the use of glaucoma drainage
devices and post-operative care
considerations before implanting
any drainage device. Reference
papers and surgical video tapes
are available upon request.
FP7
• Immediate reduction of intraocular pressure
• Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse
• Implanted in a true, single-stage procedure
• Eliminates drainage tube ligature sutures,“rip-chord” sutures, occluding sutures
Model S2Ahmed™ Glaucoma Valve
Ordering Info:
Model: S2 - Ahmed™ Glaucoma Valve
Materials:
Valved Plate Body: Medical Grade PolypropyleneDrainage Tube: Medical Grade SiliconeValve: Medical Grade Silicone, Elastomer Membrane
Nominal Specs:
Thickness: 1.9 mmWidth: 13.00 mmLength: 16.00 mmSurface Area: 184.00 mm2
Tube Length: 25.00 mmTube Inner Diameter: 0.305 mmTube Outer Diameter: 0.635 mm
S2
S2 Surgical ProcedureStep 1 Step 2 Step 3 Step 4
Step 5 Step 6 Step 7 Step 8
The steps illustrated here are
intended as a guideline only, and do
not represent recommended treat-
ment for any particular patient.
The use of any specific surgical
technique or maneuver is at the
sole discretion of the surgeon.
Surgeons should be familiar with
the use of glaucoma drainage
devices and post-operative care
considerations before implanting
any drainage device. Reference
papers and surgical video tapes
are available upon request.
S2
• Made of medical grade silicone
• Used for Pediatrics or small globes
• Immediate reduction of intraocular pressure
• Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse
• Implanted in a true, single-stage procedure
• Eliminates drainage tube ligature sutures,“rip-chord” sutures, occluding sutures
• Thinner Plate
Model FP8Ahmed™ Glaucoma Valve Flexible Plate™
Ordering Info:
Model: FP8 - Ahmed™ Glaucoma Valve Small
Materials:
Valved Plate Body: Medical Grade SiliconeDrainage Tube: Medical Grade SiliconeValve: Medical Grade Silicone, Elastomer Membrane
Nominal Specs:
Width: 9.60 mmLength: 10.00 mmSurface Area: 96.00 mm2
Tube Length: 25.00 mmTube Inner Diameter: 0.305 mmTube Outer Diameter: 0.635 mm
FP8
FP8 Surgical ProcedureStep 1 Step 2 Step 3 Step 4
Step 5 Step 6 Step 7 Step 8
The steps illustrated here are
intended as a guideline only, and do
not represent recommended treat-
ment for any particular patient.
The use of any specific surgical
technique or maneuver is at the
sole discretion of the surgeon.
Surgeons should be familiar with
the use of glaucoma drainage
devices and post-operative care
considerations before implanting
any drainage device. Reference
papers and surgical video tapes
are available upon request.
FP8
• Used for Pediatrics or small globes
• Immediate reduction of intraocular pressure
• Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse
• Implanted in a true, single-stage procedure
• Eliminates drainage tube ligature sutures,“rip-chord” sutures, occluding sutures
Model S3Ahmed™ Glaucoma Valve
Ordering Info:
Model: S3 - Ahmed™ Glaucoma Valve Small
Materials:
Valved Plate Body: Medical Grade PolypropyleneDrainage Tube: Medical Grade SiliconeValve: Medical Grade Silicone, Elastomer Membrane
Nominal Specs:
Width: 9.60 mmLength: 10.00 mmSurface Area: 96.00 mm2
Tube Length: 25.00 mmTube Inner Diameter: 0.305 mmTube Outer Diameter: 0.635 mm
S3
S3 Surgical ProcedureStep 1 Step 2 Step 3 Step 4
Step 5 Step 6 Step 7 Step 8
The steps illustrated here are
intended as a guideline only, and do
not represent recommended treat-
ment for any particular patient.
The use of any specific surgical
technique or maneuver is at the
sole discretion of the surgeon.
Surgeons should be familiar with
the use of glaucoma drainage
devices and post-operative care
considerations before implanting
any drainage device. Reference
papers and surgical video tapes
are available upon request.
S3
• Made of medical grade silicone
• Attachable on either right or left side
• Bi-Plate design allows for greater aqueous drainage
• Valve and Bi-Plate surface area: 364mm2
• Immediate reduction of intraocular pressure
• Unique, non-obstructive valve system to prevent exces-sive drainage, chamber collapse
• Implanted in a true, single-stage procedure
• Eliminates drainage tube ligature sutures,“rip-chord” sutures, occluding sutures
Model FX1Ahmed™ Glaucoma Valve Flexible Bi-Plate™
Ordering Info:
Model: FX1(Model FP7 with non-valved Plate)
Materials:
Valved Plate Body: Medical Grade SiliconeDrainage Tube: Medical Grade SiliconeValve: Medical Grade Silicone, Elastomer Membrane
Nominal Specs:
Valved Plate Non-Valved PlateWidth: 13.00 mm 12.20 mmLength: 16.00 mm 14.80 mmTube Length: 25.00 mm 25.00 mmSurface Area: 184.00 mm2 180.00 mm2
Tube Inner Diameter: 0.305 mm 0.305 mmTube Outer Diameter: 0.635 mm 0.635 mm
FX1
• Attachable on either right or left side
• Bi-Plate design allows for greater aqueous drainage
• Valve and Bi-Plate surface area: 364mm2
• Immediate reduction of intraocular pressure
• Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse
• Implanted in a true, single-stage procedure
• Eliminates drainage tube ligature sutures,“rip-chord” sutures, occluding sutures
Model B1Ahmed™ Glaucoma Valve Bi-Plate™
Ordering Info:
Model: B1(Model S2 with non-valved Plate)
Materials:
Valved Plate Body: Medical Grade PolypropyleneDrainage Tube: Medical Grade SiliconeValve: Medical Grade Silicone, Elastomer Membrane
Nominal Specs:
Valved Plate Non-Valved PlateWidth: 13.00 mm 12.20 mmLength: 16.00 mm 14.80 mmTube Length: 25.00 mm 25.00 mmSurface Area: 184.00 mm2 180.00 mm2
Tube Inner Diameter: 0.305 mm 0.305 mmTube Outer Diameter: 0.635 mm 0.635 mm
B1
•Made of medical grade silicone
• Used with existing implants
• Can be inserted in existing bleb
• Attachable on either right or left side
• Increases surface area of existing implant
• Can be placed over or under the muscle
• Easily sutured on sclera
Model FX4Flexible Non-Valved Plate
Ordering Info:
Model: FX4 - Non-valved Flexible Plate™
Materials:
Non-Valved Plate Body: Medical Grade SiliconeDrainage Tube: Medical Grade Silicone
Nominal Specs:
Width: 12.20 mmLength: 14.80 mmSurface Area: 180.00 mm2
Tube Length: 25.00 mmTube Inner Diameter: 0.305 mmTube Outer Diameter: 0.635 mm
Non-Valved Plate
End fi xed to the Valved Plate
FX4
FX4 Surgical ProcedureStep 1 Step 2 Step 3 Step 4
Step 5 Step 6 Step 7
The steps illustrated here are
intended as a guideline only, and do
not represent recommended treat-
ment for any particular patient.
The use of any specific surgical
technique or maneuver is at the
sole discretion of the surgeon.
Surgeons should be familiar with
the use of glaucoma drainage
devices and post-operative care
considerations before implanting
any drainage device. Reference
papers and surgical video tapes
are available upon request.
FX4
• Used with existing implants
• Can be inserted in existing bleb
• Attachable on either right or left side
• Increases surface area of existing implant
• Can be placed over or under the muscle
• Easily sutured on sclera
Model B4Non-Valved Plate
Ordering Info:
Model: B4 - Non-valved Plate
Materials:
Non-Valved Plate Body: Medical Grade PolypropyleneDrainage Tube: Medical Grade Silicone
Nominal Specs:
Width: 12.20 mmLength: 14.80 mmSurface Area: 180.00 mm2
Tube Length: 25.00 mmTube Inner Diameter: 0.305 mmTube Outer Diameter: 0.635 mm
Non-Valved Plate
End fi xed to the Valved Plate
B4
B4 Surgical ProcedureStep 1 Step 2 Step 3 Step 4
Step 5 Step 6 Step 7
The steps illustrated here are
intended as a guideline only, and do
not represent recommended treat-
ment for any particular patient.
The use of any specific surgical
technique or maneuver is at the
sole discretion of the surgeon.
Surgeons should be familiar with
the use of glaucoma drainage
devices and post-operative care
considerations before implanting
any drainage device. Reference
papers and surgical video tapes
are available upon request.
B4
• Provides for valve tube insertion into the pars plana
• Fully adjustable along length of tube
• Does not compromise integrity of valve tube
• Smooth curvature eliminates kinking
• Can be used with any drainage device
• Easily sutured on sclera
Model PCPars Plana Clip™
Ordering Info:
Model: PC - Pars Plana Clip™
Materials:
Clip: Medical Grade Silicone
Nominal Specs:
Width: 4.60 mmLength: 5.80 mmTube Inner Dia.: 0.635 mmPositioning Holes Dia.: 0.025 mm
Into Posterio
r Cham
ber
To Valve
PC
• Provides extra tube length for necessary cases
• Provides leak-proof junction between tubes
• Helpful in cases where drainage tube is cut too short
• Can be used with any drainage device
• Easily sutured on sclera
Model TETube Extender™
Materials:
Junction: Medical Grade SiliconeDrainage Tube: Medical Grade Silicone
Ordering Info:
Model: TE - Tube Extender™
Nominal Specs:
Width: 3.050 mmLength: 4.750 mmHeight: 1.140 mmTube Length: 24.13 mmTube Inner Diameter: 0.305 mmTube Outer Diameter: 0.635 mm2 Positioning Holes: 0.025 in dia.
Tube from the Valve
TE
Models PC7 & PC8Ahmed™ Glaucoma Flexible Plate™ with Pars Plana Clip™
Ordering Info:
Model: PC7 (Model FP7 with Pars Plana Clip™)Model: PC8 (Model FP8 with Pars Plana Clip™)
Materials:
Valved Plate Body: Medical Grade SiliconeDrainage Tube: Medical Grade SiliconeValve: Medical Grade Silicone, Elastomer MembraneClip: Medical Grade Silicone
• Made of medical grade silicone
• Model FP7 and FP8 valves already integrated with Pars Plana Clip™
• Reduces preptime for posterior chamber insertions
• Clip is fully adjustable along tube length
• Easily sutured on sclera
• Clip allows the tube not to kink
Model PC7
Model PC8
PC7 & PC8
Models PS2 & PS3Ahmed™ Glaucoma Valve with Pars Plana Clip™
Ordering Info:
Model: PS2 (Model S2 with Pars Plana Clip™)Model: PS3 (Model S3 with Pars Plana Clip™)
Materials:
Valved Plate Body: Medical Grade PolypropyleneDrainage Tube: Medical Grade SiliconeValve: Medical Grade Silicone, Elastomer MembraneClip: Medical Grade Silicone
• Model PS2 and PS3 valves already integrated with Pars Plana Clip™
• Reduces preptime for posterior chamber insertions
• Clip is fully adjustable along tube length
• Easily sutured on sclera
• Clip allows the tube not to kink
Model PS2
Model PS3
PS2 & PS3
• Notched tip secures valve tube• Provides rigidity to valve tube for easy insertion into an-
terior or posterior chamber• Stainless steel• Serrated grip• Shorter tip helps to provide better view through micro-
scope• Very inexpensive• Re-usable• Can be used with any drainage device
Model TITube Inserter™
Ordering Info:
Model: TI - Tube Inserter™
TI
• Biocompatible human tissue• Gamma sterilized• 2.5 years shelf life• Nominal thickness 0.5 mm• Pretrimmed for ease of placement• Available Freeze Dried or Hydrated for immediate use• Cost effective• Available as full thickness sclera or pericardium• Available in all sizes• Can be used as occular tissue for other cosmetic uses• Used for leaking blebs
Human Allograft TissueSclera & Pericardium
Ordering Info:
TSH (Human Sclera)TPH (Hydrated Pericardium)TPD (Freeze Dried Pericardium)
TSH / TPH / TPD
Comparison of Ahmed™ Glaucoma Valve with Other Drainage Devices
Product
Ahmed™ Glaucoma Valve
Baerveldt
Molteno
Drainage Device
Model S3Model S2Bi-Plate
BG103-250BG-101-350BG103-425
Single PlateDouble Plate
Surface Area
96mm2
184mm2
364mm2
250mm2
350mm2
425mm2
135mm2
270mm2
Valved/Non-Valved
ValvedValvedValved
Non-ValvedNon-ValvedNon-Valved
Non-ValvedNon-Valved
Type
Success Rate(Lowering of IOP)
Visual Acuity(Improved or withinone Snellen Line)
Hypotony(Occurrence)
Success Ratewith Corneal Grafts
Ahmed™ Glaucoma Valve
95%
82%
8%
84.10%
Baerveldt
72%
62%
26%
54%
Molteno
60%
70%
14.60%
76%
Coleman AL, Mondino BJ, Wilson MR, Casey R. Clinical Experience with the Ahmed™ Glaucoma Valve Implant in Eye with Prior or Concurrent Penetrating Keratoplasties. American Journal of Ophthalmology 1997; 123:54-61
Hodkin MJ, Goldblatt WS, Burgoyne CF, Ball SF. Early Clinical Experience with the Baerveldt Implant in Complicated Glaucomas. American Journal of Ophthalmology 1995; 120:32-40Huang MC, Netland PA, Coleman AL, Siegner SW, et al. Intermediate-term Clinical Experience with the Ahmed™ Glaucoma Valve Implant. American Journal of Ophthalmology 1999;
127:27-33Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, et al. Intermediate Term Results of a Randomized Clinical Trial of the 350 versus the 500mm Baerveldt Implant.
Ophthalmology 1994; 101:1456-1464McDonnell PJ, Robin JB, Schanzlin DJ, Minckler D, et al. Molteno Implant for Control of Glaucoma in Eyes After Penetrating Keratoplasty. Ophthalmology 1988; 95:364-369Melmed S. Cahane M, Gutman I, Blumenthal M. Postoperative Complications After Molteno Implant Surgery. American Journal of Ophthalmology 1991; 1:319-322Mermoud A. Salmon JF, Straker C. Murray AND. Use of the Single Plate Molteno Implant in Refractory Glaucoma. Ophthalmologica 1992; 205:113-120