| 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, Schiff man 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 fi ve 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, infl ammation, 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 eff usion, hypotony, fl at 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.
PP2023OTH5520
