BAERVELDT® Glaucoma Implants
BAERVELDT® Glaucoma Implants
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
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