Description

DemeSILK Silk Sutures by DemeTECH are expertly crafted for surgical precision and reliability. These non-absorbable, multifilament sutures are made from fibroin, a protein derived from the domesticated silkworm, Bombyx mori. The unique composition provides exceptional handling and knot security, making them ideal for various surgical applications.

Features

• Braided Construction: The multifilament, braided structure enhances handling and ensures secure knotting, crucial for effective tissue approximation and ligation.
• Silicon Coating: Each suture is silicon-coated, allowing for smooth passage through tissue and increased ductility.
• Color Options: Available in both dyed black and undyed white, offering visibility options to suit different surgical needs.

Specifications

• Sizes: Offered in a range of sizes from USP 8-0 to 2 (Metric 0.5 to 7), accommodating diverse surgical requirements.
• Needle Variants: Available with or without attached needles, featuring various types such as reverse cutting and round bodied, in different shapes and lengths.
• Lengths: Common suture lengths include 45 cm, 75 cm, and 30 inches, varying by size and variant.

Indications

DemeSILK Sutures are suitable for general soft tissue approximation, ligation in surgical procedures, and ophthalmic surgeries. They are intended for long-term use, with gradual tensile strength loss over time, mostly within one year.

Handling and Performance

Upon implantation, the sutures may cause an acute inflammatory reaction, followed by encapsulation by fibrous connective tissue within 14 to 21 days. This characteristic ensures reliable performance in appropriate surgical settings.

Precautions

• Single Use: These sutures are sterile and intended for single use only. Reuse or resterilization is not recommended.
• Allergy Considerations: Not suitable for patients with known silk allergies.
• Storage: Store below 25°C, away from heat and moisture.

Contraindications

DemeSILK Sutures are not recommended where permanent tensile strength is required or for use in the heart, central circulatory, or central nervous systems. They are also contraindicated in urinary or biliary tracts due to potential stone formation.

Packaging

Each suture is supplied in sterile, pre-cut lengths, typically packaged in boxes of 12. The packaging is designed to maintain sterility and ensure convenient access during surgical procedures.

Regulatory Compliance

These sutures meet rigorous standards, including CE marking and compliance with the Medical Device Directive 93/42/EEC. They conform to USP and TGA standards, underscoring their quality and reliability in medical applications.