Description
Biosyn™ Monofilament Absorbable Suture by Medtronic, Inc. is a versatile surgical suture designed for effective soft tissue approximation and subcuticular skin closure. It is also suitable for ligation and ophthalmic surgery, though not recommended for cardiovascular or neurological procedures.
Composition
Crafted from Gylcomer 631, Biosyn™ is a synthetic polyester comprising:
- Glycolide (60%)
- Dioxanone (14%)
- Trimethylene Carbonate (26%)
This unique composition contributes to its absorbable monofilament structure.
Physical Characteristics
- Color Options: Available in violet for enhanced visibility and undyed for discretion.
- Size Range: Offers a variety of sizes from 1 to 5/0.
- Length Options: Comes in different lengths such as 45 cm and 75 cm.
- Needle Types: Includes reverse cutting and premium reverse cutting needles, made from Surgalloy stainless steel for superior performance.
Performance Features
Biosyn™ provides high initial and in-vivo tensile strength, maintaining this strength for approximately 21 to 30 days, aligning with critical wound healing periods. It fully absorbs in about 90 days, ensuring minimal long-term presence.
- Knot Security: Offers excellent knot security.
- Handling: Minimal memory for ease of handling, providing continuous and uniform tension during application.
Sterilization and Storage
- Sterilization: Conducted using ethylene oxide (ETO).
- Shelf Life: Five years when stored at 20–25°C with relative humidity below 65%.
- Storage Recommendations: Keep away from direct sunlight, store on wooden or plastic pallets at least 10 cm above the floor.
Safety and Regulatory Information
Biosyn™ is free from natural rubber latex and DEHP, enhancing its safety profile. It carries a CE mark, classified as Class IIb or III depending on jurisdiction, with a GMDN code of 45814.
Packaging
Available in boxes containing 1, 2, or 3 dozen sutures, accommodating various surgical needs. Multiple reference codes exist to specify configurations such as needle type, suture size, length, and color.
