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Important Safety Information – BAERVELDT® Glaucoma Implants

INDICATIONS

For use in patients (with prior vitrectomy for Pars Plana) with medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to: neovascular glaucoma, aphakic/pseudophakic glaucomas, patients who have failed conventional surgery, congenital glaucomas and secondary glaucomas due to uveitis, epithelial downgrowth, etc.

WARNINGS

Do not use the device if sterile package integrity has been compromised. Do not resterilize the implant by any method. Do not reuse the implant. Do not store at temperatures above 45°C (113°F).

CONTRAINDICATIONS

Bacterial conjunctivitis, bacterial corneal ulcers, endophthalmitis, orbital cellulitis, bacteremia or septicemia, active scleritis and/or no light perception.

COMPLICATIONS/ADVERSE EVENTS

The complications during and after surgery include, but are not limited to: chorodial hemorrhage, hyphema, serous choroidal effusion, hypotony, flat anterior chamber, phthisis bulbi, retinal detachment, endophthalmitis, tube erosion, tube touch to cornea, tube block by iris or vitreous, bullous keratopathy, uveitis and diplopia.

BAERVELDT<sup>®</sup> BG 101-350 Glaucoma Implant

For use in patients (with prior vitrectomy for Pars Plana) with medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to: neovascular glaucoma, aphakic/pseudophakic glaucomas, patients who have failed conventional surgery, congenital glaucomas and secondary glaucomas due to uveitis, epithelial downgrowth, etc.

BAERVELDT® glaucoma implants are available in three models, all of which feature a larger surface area plate than competing single-quadrant devices.

This large surface area combines with a streamlined design to result in a proven surgical option for patients suffering from uncontrollable glaucoma.

Features

  • Large Surface Area Plates
  • Single-quadrant insertion
  • Patented bleb control mechanism
  • Decreased Bleb Height
  • Low Incidence of Motility Disorders
  • Low Edge Height
  • Smooth, tumble-polished, pliable silicone plate material1,6
  • Radiographic material1,6
  • Four fenestrations to promote fibrous adhesion, which may reduce bleb height1,3,5
  • An open drainage tube1,6,7,8
  • Fixation suture holes1,6
  • Recessed knot capability1

Benefits

  • Long-term intraocular pressure (IOP) control3,4
  • Easier implantation3
  • Reduced surgical time4
  • Less trauma2,4
  • Faster healing4

Features

Larger Surface Area

The design of BAERVELDT® glaucoma implants provides maximal surface areas for aqueous filtration and pressure relief. The BAERVELDT® 250 model is 115 mm2 larger than the single-plate Molteno®* 135.1

Large surface areas may be more effective in controlling long-term intraocular pressure (IOP) than smaller plates,3,4 and there may be fewer post operative, anti glaucoma medications needed.3,4

Single-Quadrant Insertion

Because the surface area of BAERVELDT® glaucoma implants are larger than other single-plate implants, the surgical implantation is limited to a single quadrant of the globe. Implanting devices such as the double-plate Molteno®* implant or the double-plate Ahmed®† implant involve two or more quadrants.3 Single-quadrant insertion is a technically simpler and faster technique that allows a large surface area plate to be installed with less trauma.2,4

BAERVELDT® glaucoma implants have flexible tie-off capability, which can be tight or loose to match complicated procedures.1

** MOLTENO is a trademark of Molteno, Anthony Christopher Bernard and AHMED is a trademark of New World Medical, Inc.

Patented bleb control mechanism

Unique fenestrations allow the growth of fibrotic tissue through the fenestrations, thereby 'riveting' the bleb to the sclera.1,3,5

  • Designed to control bleb height and volume3,5
  • Secures the plate in place5
  • Minimizes potential for ocular motility disturbances5

Echographic appearance of fenestrated BAERVELDT® plate (p) with underlying and overlying bleb (B), transverse B-scan. Arrow = fibrous tissue bridging bleb through fenestrations.

Patented fenestrations promote tissue growth, riveting the bleb to the sclera and potentially reducing bleb height by as much as 50 percent.3,5

Decreased Bleb Height

Patented fenestrations are designed to minimize bleb height and volume, which helps to reduce ocular motility disturbances. Four exclusive fenestrations were added to the design of the plate. These fenestrations allow ingrowth of fibrous tissue. This connects the upper and lower walls of the blebs limiting their height. The fibrous adhesions between the sclera and the inner surface of the bleb may minimize bleb height by securing the inner surface of the bleb closer to the underlying sclera.1,3,5

Low Incidence of Motility Disorders

In a published review of 50 patients, four cases (8%) experienced ocular motility disturbance. None of the patients with motility disturbance had received an implant with fenestrated plates.5

Low Edge Height

Three different sizes of BAERVELDT® glaucoma implants can meet a variety of clinical demands. Implants are tumble-polished, soft, and flexible. BAERVELDT® glaucoma implants also feature low edge height with a low implant profile of 0.84 mm, for excellent globe fit.1,6

Surgical Procedures

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References

  1. Device comparison in glaucoma drainage. May 2000. Abbott Medical Optics Inc., Santa Ana, CA.
  2. Heuer DK, Lloyd MA, Abrams, DA, et al. Which is better? One or two? A randomized clinical trial of single-plate versus double-plate Molteno implantation for glaucomas in aphakia and pseudophakia. Ophthalmology. 1992;99:1512-1519.
  3. Lloyd MA, Baerveldt G, Fellenbaum PS, et al. Intermediate-term results of a randomized clinical trial of the 350 - versus the 500 mm2 Baerveldt Implant. Ophthalmology. 1994;101:1456-1464.
  4. Fellenbaum PS, Sidoti P, Heuer DK, Minckler DS, Baerveldt G, Lee PP. Experience with the Baerveldt implant in young patients with complicated glaucomas. J Glaucoma. 1995;4:91-97.
  5. Hodkin MJ, Goldblatt WS, Burgoyne CF, Ball SF, Insler MS. Early clinical experience with the Baerveldt implant in complicated glaucomas. Am J Ophthalmol. 1995;120:32.
  6. Baervelt package insert. October 2000. Abbott Medical Optics Inc., Santa Ana, CA.
  7. Minckler DS. Perspectives on glaucoma drainage implants. Ophthalmol Clin North Am. 1995;8:383-391.
  8. Prata JA Jr, Mermoud A, LaBree L, Minckler DS. In vitro and in vivo flow characteristics of glaucoma drainage implants. Ophthalmology. 1995;102:894-904.
  9. Siegner SW, Netland PA, Urban RC Jr, et al. Clinical experience with the Baerveldt glaucoma drainage implant. Ophthalmology. 1995;102:1298-1307.
  10. Britt MT, LaBree LD, Lloyd MA, et al. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results. Is bigger better? Ophthalmology. 1999;106:2312-2318.
  11. Krishna R, Godfrey DG, Budenz DL, et al. Intermediate-term outcomes of 350-mm2 Baerveldt glaucoma implants. Ophthalmology. 2001;108:621-626.
  12. Kansal S, Moster MR, Kim D, Schmidt CM Jr, Wilson RP, Katz LJ. Effectiveness of nonocclusive ligature and fenestration used in Baerveldt aqueous shunts for early postoperative intraocular pressure control. J Glaucoma. 2002;11:65-70.

Comparison Matrix

  BAERVELDT® 250 mm2
BG103-250 Implant
BAERVELDT® 350 mm2
BG101-350 Implant
BAERVELDT® 350 mm2 Pars Plana BG102-350 Implant
Surface Area 250 mm2 350 mm2 350 mm2
Material Smooth, tumble-polished, pliable medical grade silicone Smooth, tumble-polished, pliable medical grade silicone Smooth, tumble-polished, pliable medical grade silicone
Single Quadrant Insertion Yes Yes Yes
Radiographic Material Yes Yes Yes
Bleb Control Mechanism 4 Fenestrations 4 Fenestrations 4 Fenestrations
Designed for Posterior Chamber Placement No No Yes
Drainage Mechanism Open Tube Open Tube Open Tube with Hoffmann Elbow
Indications Medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to:
  • neovascular glaucoma; aphakic/pseudophakic glaucomas; failed conventional surgery, congenital glaucoma;
  • secondary glaucoma due to uveitis, epithelial downgrowth
Medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to:
  • neovascular glaucoma; aphakic/pseudophakic glaucomas; failed conventional surgery, congenital glaucoma;
  • secondary glaucoma due to uveitis, epithelial downgrowth
Patients with prior vitrectomy Medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to:
  • neovascular glaucoma; aphakic/pseudophakic glaucomas; failed conventional surgery, congenital glaucoma;
  • secondary glaucoma due to uveitis, epithelial downgrowth
Fixation Suture Holes Yes Yes Yes
Recessed Knot Capability Yes Yes Yes
Contraindications Include bacterial conjunctivitis, bacterial corneal ulcers, endophthalmitis, orbital cellulitis, bacteremia or septicemia, active scleritis and/or no light perception.
Potential Complications Reported complications during and after surgery include, but are not limited to: choroidal hemorrhage, hyphema, serous choroidal effusion, hypotony, flat anterior chamber, phthisis bulbi, retinal detachment, endophthalmitis, tube erosion, tube touch to cornea, tube block by iris or vitreous, bullous keratopathy, uveitis, and diplopia.
 

Expert Comments / IOP Reduction

The Baerveldt® glaucoma implant is popular because it affords the combination of one-quadrant installation and a large surface area.10

Britt MT et al. Ophthalmology. 1999;106(12):2312-2318.

The 350 mm2 Baerveldt® Glaucoma Implants are a safe and effective treatment for intermediate-term intraocular pressure (IOP) control in patients with refractory glaucoma.

Baerveldt® glaucoma implants are an effective and safe surgical procedure for glaucoma refractory to other surgical or medical management methods.11

Krishna R et al. Ophthalmology. 2001;108(3):621-626.

Both the nonocclusive ligature and the fenestration methods [used with the Baerveldt® glaucoma implant] provide desirable decreases in IOP in the immediate postoperative period and 3 months postoperatively.12

Kansal S et al. J Glaucoma. 2002;11(1):65-70.

"The Baerveldt® glaucoma implant is effective in lowering the IOP in patients with intractable glaucomas. Hypotony and other complications are common, which also have been reported in other nonvalved glaucoma drainage implants. However, the majority of these complications did not affect surgical outcome."9

Siegner SW et al. Ophthalmology. 1995;102(9):1298-1307.

The Baerveldt® glaucoma implant is indicated for use in patients with medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to: neovascular glaucoma; aphakic/pseudophakic glaucomas; failed conventional surgery, congenital glaucoma; and secondary glaucoma due to uveitis, epithelial downgrowth, etc.

Contraindications include bacterial conjunctivitis, bacterial corneal ulcers, endophthalmitis, orbital cellulitis, bacteremia or septicemia, active scleritis and/or no light perception.

Reported complications during and after surgery include, but are not limited to: choroidal hemorrhage, hyphema, serous choroidal effusion, hypotony, flat anterior chamber, phthisis bulbi, retinal detachment, endophthalmitis, tube erosion, tube touch to cornea, tube block by iris or vitreous, bullous keratopathy, uveitis, and diplopia.

Watch Surgical Video Clips

 

  1. Suture traction, paracentesis and viscoelastic
  2. Incision and identification of lateral and superior rectus muscle
  3. Implantation
  4. Suturing of shunt
  5. Ligating of the tube
  6. Trim and insert the tube in the anterior chamber
  7. Suturing of graft
  8. Close incision

Important Safety Information – BAERVELDT® Glaucoma Implants

INDICATIONS

For use in patients (with prior vitrectomy for Pars Plana) with medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to: neovascular glaucoma, aphakic/pseudophakic glaucomas, patients who have failed conventional surgery, congenital glaucomas and secondary glaucomas due to uveitis, epithelial downgrowth, etc.

WARNINGS

Do not use the device if sterile package integrity has been compromised. Do not resterilize the implant by any method. Do not reuse the implant. Do not store at temperatures above 45°C (113°F).

CONTRAINDICATIONS

Bacterial conjunctivitis, bacterial corneal ulcers, endophthalmitis, orbital cellulitis, bacteremia or septicemia, active scleritis and/or no light perception.

COMPLICATIONS/ADVERSE EVENTS

The complications during and after surgery include, but are not limited to: chorodial hemorrhage, hyphema, serous choroidal effusion, hypotony, flat anterior chamber, phthisis bulbi, retinal detachment, endophthalmitis, tube erosion, tube touch to cornea, tube block by iris or vitreous, bullous keratopathy, uveitis and diplopia.



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