Description

The ENDO GUIDEWIRE by ENDO-FLEX is a specialized medical device designed for precision in endoscopic and interventional gastroenterological procedures. This sterile, single-use guidewire is crafted to assist trained physicians in the accurate placement of diagnostic or therapeutic devices within hollow organs.

Material and Design

• Core Material: Available in nitinol and stainless steel, offering options for kink resistance and enhanced torque control.
• Surface Coating: Includes Teflon/PTFE and hydrophilic coatings to minimize friction, facilitating smooth navigation.

Tip Configurations

• Flexibility: Tips range from straight to curved, with shapes such as straight, angled, and J-formed.
• Visibility: Radiopaque markers enhance fluoroscopic visibility, while hydrophilic coatings provide seamless movement.

Shaft Options

• Variability: Comes in standard to super stiff configurations, with double-ended designs for versatile application.
• Coating: A smooth, homogeneous surface reduces friction and prevents blood drainage.

Dimensions

• Diameter: Options include 0.018", 0.020", 0.025", 0.035", 0.038", and 0.052".
• Length: Ranges from 100 cm to 600 cm, catering to diverse procedural needs.

Indications for Use

Ideal for procedures such as:

• Biliary and pancreatic duct access
• Biliary stone removal
• Pancreatic duct stenting
• Biliary stricture management

Contraindications

• Not suitable for cerebral vascular intervention or use in MR fields.
• Not intended for pediatric use in certain variants.

Handling Instructions

• Single Use: Do not reuse or resterilize.
• Storage: Keep dry, in original packaging, away from sunlight and chemicals.
• Inspection: Check packaging integrity and expiration before use.

Safety Precautions

• Professional Use: Intended for use by trained medical specialists.
• Potential Complications: Includes soft tissue injury, infection, and wire fracture.
• Packaging: Do not use if packaging is damaged or expired.

Disposal

Post-use, the guidewire should be disposed of according to medical waste protocols, as it cannot be effectively cleaned or sterilized.

Packaging and Identification

• Sterilization: Each guidewire is sterilized using ethylene oxide and individually packed.
• Barcode: Features a 2D barcode for easy identification, ensuring traceability and compliance with medical standards.