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    BAERVELDT® Glaucoma Implants

    BAERVELDT® Glaucoma Implants

     
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    Instructional Guides

    Instructional Guides

    Instructional Guides

     

    Easing the Pressure

    The BAERVELDT® BG 103-250, BAERVELDT® BG 101-350 and BAERVELDT® Pars Plana BG 102-350 Glaucoma Implants

    Provide pressure control with a minimally invasive BAERVELDT® Glaucoma Implant. Its fenestration system is designed to control bleb height and volume while a patented larger surface area enhances IOP control.1,2 When traditional glaucoma therapy can’t help the rising IOP, provide control with a BAERVELDT® Glaucoma Implant.

    Large plate implants, such as BAERVELDT® Implants, facilitate aqueous outflow to help provide IOP control.3

    • Allows improved aqueous filtration
    • Maximizes pressure relief

    BAERVELDT® Implants only require single-quadrant insertion, allowing for better IOP control than competing implants.4,5

    The BAERVELDT® Implants’ patented bleb control mechanism allows fibrotic tissue growth through the fenestrations in the plate, controlling bleb height and volume.2,6

    • Minimizes the likelihood of ocular motility disturbances5
    • Helps ensure a low profile for better globe fit
     

    BAERVELDT® BG 103-250 Glaucoma Implant

    BAERVELDT® BG 101-350 Glaucoma Implant

    BAERVELDT® Pars Plana BG 102-350 Glaucoma Implant

    Surface Area:

    250 mm2

    350 mm2

    350 mm2

    Plate Length:

    22 mm

    32 mm

    32 mm

    Tube Length:

    32 mm

    32 mm

    7 mm

    Fenestrations:

    4

    4

    4

    Placement:

    Anterior chamber

    Anterior chamber

    Posterior chamber (Pars Plana)

    Drainage Mechanism:

    Open tube

    Open tube

    Open tube with Hoffman Elbow

    REFERENCES

    1. Gedde S, Schiffman J, Feuer W, et al. Treatment outcomes in the tube versus trabeculectomy study after one year of follow-up. Am J Ophthalmol.2007;143(1):9-22.
    2. 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(8):1456-1464.
    3. Gedde, S. et al. Treatment outcomes in the tube versus trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012;153(5).
    4. 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(10):1512-1519.
    5. 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(2):91-97.
    6. Hodkin MJ, Goldblatt WS, Burgoyne CF, Ball SF, Insler MS. Early clinical experience with the Baerveldt implant in complicated glaucomas. Am J Ophthalmol. 1995(1);120:32.
     

    INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR BAERVELDT® GLAUCOMA IMPLANTS

    Rx Only

    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.

    CONTRAINDICATIONS

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

    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). Johnson & Johnson Surgical Vision single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The reuse of/resterilization/reprocessing of single- use Johnson & Johnson Surgical Vision, Inc. medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. JJSV single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user.

    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.

    ATTENTION

    Reference the labeling for a complete listing of Indications and Important Safety Information.

    PP2021CT4043