Balloon Guide Catheters
EMBOGUARD Balloon Guide Catheter
Indications for Use
EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.
Key Specifications
- Dual lumen, braid-reinforced, variable stiffness catheter
- Eccentric inflation lumen
- Radiopaque marker on the distal end (Pt-Ir marker band, 1.3 mm from distal tip, length 0.031")
- Bifurcated luer hub on the proximal end
- Compliant balloon mounted on the distal end (polyblend material)
- Hydrophilic coating on the distal end of the device shaft
- Shaft outer diameter: 8F (2.8 mm)
- Shaft inner diameter: 6.6F (0.087")
- Tip shape: Straight
- Balloon inflation lumen: Non-coaxial
- Effective balloon length options: 85 cm, 95 cm
- Materials: Pebax blends (e.g., Pebax 3533 SA01 MED, Pebax 5533 SA01 MED), nylon, PTFE, polycarbonate, polyurethane, polyolefin, polyblend, stainless steel braid
- Colorants: CSRM016 Pigment Blue 36, CSRM037 Pigment Violet 23, CSRM035 Pigment Green 7, Techmer Blue/Black (PM50167E1)
- Additives: Irganox 1010, Tinuvin 622
- Accessories provided: Dilator (1), Rotating Hemostasis Valve (1), Peel Away Sheath (1), Luer-Activated Valve (1)
- Sterile, single-use device
- Sterilization method: Ethylene Oxide (EtO)
- Sterility assurance level: 10^{-6}
- Shelf life: 1 year
- Inner lumen liner forming process: Film cast forming
- Reinforced catheter shaft: Stainless steel braid
Description
EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.