Válvulas Ahmed modelos.

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Transcript of Válvulas Ahmed modelos.

Page 1: Válvulas Ahmed modelos.
Page 2: 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.

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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

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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™

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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

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• 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

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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

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• 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

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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

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• 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

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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

Page 12: Válvulas Ahmed modelos.

• 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

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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

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• 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

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• 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

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•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

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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

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• 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

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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

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• 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

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• 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

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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

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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

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• 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

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• 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

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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

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