Introducer Shealth
Product Introduction – Introducer Sheath
The Introducer Sheath is a high-performance vascular access device designed for percutaneous insertion of diagnostic or interventional catheters. It provides a smooth, atraumatic pathway into vessels, minimizing insertion friction and tissue trauma. Available in short sheath (4–10Fr, 10cm) and long sheath (5–7Fr, 25cm) configurations, it supports a wide range of endovascular procedures. Manufactured under ISO 13485, holds CE certification, and complies with EU Class III medical device regulations. Features include a radiolucent hub, hemostasis valve, side port with extension line, and hydrophilic coating optional for enhanced kink resistance and maneuverability.
Key Features & Benefits
- Optimized Sheath ConfigurationsAvailable in two versatile series to meet diverse clinical needs:
- Short Sheath: 4Fr to 10Fr, 10 cm length – ideal for femoral, radial, and brachial access in routine diagnostic and interventional procedures.
- Long Sheath: 5Fr to 7Fr, 25 cm length – provides enhanced support and reach for deeper vessel navigation and complex interventions.
- Advanced Design for Superior Performance
- Radiolucent Hub: Ensures excellent fluoroscopic visibility while maintaining a low-profile design.
- Reliable Hemostasis Valve: Effectively prevents blood reflux and air embolism, allowing smooth catheter manipulation with minimal blood loss.
- Side Port with Extension Line: Facilitates convenient flushing, contrast injection, and pressure monitoring without interrupting the procedure.
- Smooth Tapered Dilator: Provides seamless transition from dilator to sheath, reducing insertion force and vessel wall trauma.
- Optional Hydrophilic Coating: Significantly reduces friction, enhances trackability, and improves kink resistance, especially in tortuous anatomy.
- Enhanced Kink Resistance & ManeuverabilityReinforced wall structure combined with high-quality materials ensures excellent flexibility and pushability while maintaining structural integrity during navigation through challenging vascular pathways.
- Patient Safety & ComfortAtraumatic tip design and ultra-smooth inner and outer surfaces minimize endothelial damage and insertion site complications, promoting faster patient recovery.
Quality & Regulatory Compliance
- Manufactured in strict accordance with ISO 13485 quality management system.
- CE Certified under EU MDR (Medical Device Regulation).
- Classified as EU Class III medical device, meeting the highest safety and performance standards for invasive vascular access devices.
- Biocompatible materials tested according to ISO 10993 standards.
Intended Use
The Introducer Sheath is indicated for percutaneous introduction of catheters and other interventional devices into the femoral, radial, or brachial arteries and veins during diagnostic and therapeutic endovascular procedures.
Available Sizes
- Short Sheath: 4Fr, 5Fr, 6Fr, 7Fr, 8Fr, 9Fr, 10Fr × 10 cm
- Long Sheath: 5Fr, 6Fr, 7Fr × 25 cm
(Other customized lengths and French sizes available upon request.)
This high-performance Introducer Sheath combines clinical reliability, procedural efficiency, and patient safety, making it an essential tool for modern interventional cardiology, radiology, and vascular surgery.
FAQs – Introducer Sheath
Q: What is the intended use of this introducer sheath?
A: It is used to introduce catheters, guidewires, or other interventional devices into peripheral or central vasculature during diagnostic or therapeutic procedures.Q: What sizes are available?
A: Short sheath: 4, 5, 6, 7, 8, 9, 10Fr – 10 cm length.
Long sheath: 5, 6, 7Fr – 25 cm length.
Custom lengths available upon request.Q: Does the sheath have a hemostasis valve?
A: Yes. All models are equipped with a tight-seal hemostasis valve to minimize blood loss and air embolism during device exchanges.Q: Is hydrophilic coating available?
A: Yes. An optional hydrophilic coating is available for reduced friction and smoother insertion, particularly recommended for tortuous or calcified vessels.Q: What is the regulatory status of this product?
A: It is CE marked under EU MDR Class III, the highest risk class for medical devices, and manufactured in compliance with ISO 13485.Q: Can this sheath be used for prolonged procedures?
A: Yes. The sheath is designed for short-term use during interventional procedures. Indwelling time should be determined by the clinician based on patient condition and procedural requirements.Q: Is the sheath radiopaque?
A: The sheath body is radiolucent, but the tip is radiopaque for precise visualization under fluoroscopy.Q: How is the product packaged and sterilized?
A: Supplied sterile via ethylene oxide (EO). Double-peel pouch packaging. Single-use only – do not resterilize. Shelf life: 3 years.Q: What should I do if I experience kinking during insertion?
A: Ensure the vessel path is adequately dilated and consider using the hydrophilic-coated version. If resistance persists, confirm sheath size compatibility with the vessel diameter.Q: Who do I contact in case of product complaint or adverse event?
A: Please report any serious incidents to the manufacturer and your local competent authority.
