Description

The ENDO GUIDEWIRE by ENDO-FLEX is a specialized medical device engineered for precision and reliability in endoscopic procedures, particularly during Endoscopic Retrograde Cholangiopancreatography (ERCP). Its primary function is to facilitate wire-guided cannulation, allowing for the accurate introduction and placement of diagnostic or interventional devices within the biliary and pancreatic ducts.

Key Features

• Material Composition: The guidewire features a nitinol core, known for its exceptional kink resistance and flexibility, ensuring smooth navigation through complex anatomical pathways.
• Tip Design: Available in various configurations, the guidewire's tip is crafted from flexible plastic and comes in straight or curved forms. The hydrophilic coating on the tip significantly reduces friction, enhancing maneuverability.
• Coating and Color Options: The body of the guidewire is coated in colored plastic, with options including violet-white, violet-yellow, and green, aiding in easy identification.

Specifications

• Diameter and Length Variability: The guidewire is available in diameters ranging from 0.018" to 0.038" and lengths from 100 cm to 600 cm, providing versatility to meet diverse clinical requirements.
• Shaft Stiffness: It offers multiple shaft stiffness options—standard, stiff, extra stiff, and super stiff—allowing customization based on procedural needs.
• Radiopacity: Excellent radiopacity ensures clear visibility under fluoroscopic guidance, crucial for precise placement.

Variants

ENDOGUIDE H (Hydrophilic)

• Features a hydrophilic surface and a kink-resistant nitinol core.
• Available in multiple tip flexibilities and shaft stiffnesses.
• Double-ended configuration for specific diameters.

ENDOGUIDE SELINGER

• Fully coated with polished ends to prevent blood drainage.
• Available in stainless steel or PTFE-coated surfaces.
• Offers straight or J-formed tip configurations.

ENDOGUIDE DOUBLE ENDED SELINGER

• Double-ended design with distinct tip forms on each end.
• Coated in stainless steel or PTFE for enhanced performance.

ENDOGUIDE MOVABLE

• Similar features to SELINGER with complete coating and polished ends.

Intended Use

The ENDO GUIDEWIRE is intended for single use and is supplied sterile. It is designed for selective cannulation, catheter introduction, and device exchange during endoscopic pancreatico-biliary procedures. Placement is confirmed under fluoroscopic guidance, and gentle manipulation is advised to prevent damage.

Safety and Precautions

• Avoid using metal entry needles with MR-compatible variants.
• Do not use alcohol or solvent-containing solutions on the hydrophilic coating.
• Ensure compatibility with other devices to prevent procedural complications.

Regulatory Status

The ENDO GUIDEWIRE is CE marked as a class III device in Europe, FDA 510(k) cleared in the USA, and registered with Health Canada, affirming its compliance with major regulatory standards. It is ideally suited for use in hospitals and clinics specializing in ERCP and related endoscopic procedures, providing healthcare professionals with a reliable tool for effective patient care.