Distal Access Catheters
SOFIA PLUS Distal Access Catheter
Indications for Use
The SOFIA PLUS/Distal Access Catheters are indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries.
Key Specifications
- Single-lumen, flexible catheter with coil and braid reinforcement
- Distal segment steam-shapeable
- Hydrophilic coating (Hydak®) for navigation through vasculature
- Radiopaque marker (Platinum/Iridium) at distal end for fluoroscopy visualization
- Introducer sheath (Pebax) and shaping mandrel (stainless steel) provided
- Catheter size: 6F
- Inner diameter (ID): 0.070 inch (1.78 mm)
- Outer diameter (OD): 0.0825 inch (2.1 mm)
- Effective length: 115-135 cm
- Materials - Outer layer: polyurethane elastomer (Polyblend and Pellethane), polyether block amide (Pebax), polyamide (Grilamid)
- Materials - Inner layer: stainless steel braid/coil, PTFE, polyolefin elastomer
- Hub: Nylon
- Strain Relief: Polyurethane
- Tip configuration: Steam shapeable by user
- Guidewire compatibility: 0.035 inch
- Sterile and single use
- Sterilization method: Ethylene Oxide
- Packaging: HDPE dispenser tube, polyethylene packaging card, Tyvek® pouch, bleached sulfate carton box
- Kink resistance: No kinks at 1 cm, 4 cm, 12 cm, and 25 cm from distal tip around 0.025-0.040 inch pin gauges
- Torque strength: No breakage after 50 rotations
- Flow rate: Equivalent to or better than competitive devices at 100 psi and 300 psi with saline or contrast media
- Maximum infusion pressure: 300 psi
- Biocompatible: Non-cytotoxic, non-irritant, non-hemolytic, non-pyrogenic
Description
The SOFIA PLUS/Distal Access Catheters are a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.