Balloon Guide Catheters
Paragon 8F Balloon Guide Catheter
Indications for Use
The Paragon 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
Key Specifications
- Multi-lumen, braid-reinforced, variable stiffness catheter
- Radiopaque marker on the distal end
- Bifurcated luer hub on the proximal end
- Compliant balloon mounted on the distal end, 10 mm long
- Balloon maximum inflation volume: 0.6 mL
- Balloon diameter at maximum volume: 10 mm
- Through-lumen extends from center port of bifurcated luer hub to distal tip
- Hydrophilic coating on external distal segment, starting from proximal balloon bond and extending proximally 19 cm
- Working lengths: 85 cm and 95 cm (difference in proximal shaft segment)
- Distal flexible segment: 16 cm
- Balloon identical for both configurations
- Compatible with minimum 0.110 inch ID introducer sheaths
- Compatible with guidewires up to 0.038 inch OD
- Compatible with 6F catheters up to 0.085 inch OD
- Sterile, non-pyrogenic, single use only
- Labeled outer diameter: 8F (0.109 in)
- Labeled inner diameter: 0.087 in
- Tip shape: Straight
- Shaft outer layer materials: Pebax, Polyamide, Polyurethane
- Shaft inner layer material: PTFE
- Shaft reinforcement: Stainless steel braid
- Shaft construction: Single-wall lamination with four equally spaced 0.5 mm wide inflation lumens embedded in the wall forming a multi-lumen shaft
- Radiopacity: Distal tip has one radiopaque Pt-Ir marker band and stainless-steel reinforcement in the catheter shaft
- Coating: Hydrophilic coating
- Compliant balloon material: Low durometer (52A) polyurethane
- Hub material: Polyamide
- Strain relief material: Pebax
- Accessories provided: RHV (1), Peel-Away Sheaths (2), Three-Way Stopcocks (2), 1 mL Syringe (1), Extension Tubing (1)
- Radiopaque marker band location: 0.04 in from the distal tip edge
- Maximum balloon volume: 0.6 mL
- Sterilization method: Ethylene Oxide (EtO)
- Sterility assurance level: 10-6
- Shelf life: 12 months
- Packaging: Polyamide/Tyvek pouch, Polyethylene tubes, HDPE
Description
The Paragon™ 8F Balloon Guide Catheter (BGC) is a multi-lumen, braid-reinforced, variable stiffness catheter with 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. Balloon inflation and deflation can be facilitated through the side port of the bifurcated luer hub. The 10 mm long balloon can be inflated up to a maximum volume of 0.6 mL. At this volume, the balloon diameter is 10 mm. The through-lumen extends from the center port of the bifurcated luer hub to the distal tip. The external distal segment of the catheter shaft has hydrophilic coating to reduce friction during use. The coating starts from the proximal balloon bond and extends proximally for 19 cm in length. There are two Paragon 8F BGC configurations which have working lengths of 85 cm and 95 cm. The difference in device length resides in the proximal shaft segment only. The 16 cm distal flexible segment and the balloon are identical for both configurations. The Paragon 8F Balloon Guide Catheter is compatible with minimum 0.110 inch inner diameter (ID) introducer sheaths, guidewires up to 0.038 inch outer diameter (OD), and 6F catheters up to 0.085 inch OD. The Paragon 8F Balloon Guide Catheter is sterile, non-pyrogenic, and intended for single use only.