Description
PDS II is a high-performance absorbable surgical suture crafted from synthetic monofilament polydioxanone. Designed for medical professionals, it offers prolonged tensile strength, making it ideal for complex surgical environments where long-term support is crucial.
Key Features
- Prolonged Tensile Strength: Retains approximately 70% of its strength at two weeks and 50% at four weeks, providing reliable support during critical healing phases.
- Minimal Tissue Reactivity: Reduces the risk of adverse tissue responses, promoting smoother recovery.
- Absorbability: Gradually absorbs over six months, eliminating the need for suture removal and enhancing patient comfort.
Intended Surgical Applications
PDS II is particularly suited for:
- Soft Tissue Approximation: Effective in high-tension areas and contaminated wounds.
- Cartilage Repair: Provides robust support where needed.
- Specialized Surgeries: Indicated for ophthalmic surgery and pediatric cardiovascular surgery, especially where tissue growth is anticipated.
Handling Characteristics
While its monofilament structure offers benefits such as reduced tissue drag, it also presents challenges in handling and knot security. Surgeons should be aware of these characteristics to ensure optimal use.
Regulatory Compliance
As an FDA Class II medical device, PDS II complies with stringent regulatory standards under 21 CFR §878.4840. It meets essential requirements for:
- Biocompatibility
- Sterility
- Performance Characteristics
These standards ensure that the suture aligns with the highest quality benchmarks, adhering to USP monographs for physical attributes like diameter and tensile strength.
Additional Considerations
The suture's color additives comply with regulatory guidelines, and its resorption profile is thoroughly tested to meet expected performance outcomes. Clinical studies are generally not required unless significant changes are made to its formulation or intended use.
PDS II stands as a reliable choice for surgeons seeking an absorbable suture with enduring strength and minimal tissue interaction, tailored for specialized surgical needs.
