Description

The SUTURE PDS II ENDOLOOP by Ethicon is a specialized surgical tool designed to enhance the efficiency and effectiveness of endoscopic and laparoscopic procedures. This product features a pre-tied absorbable suture loop, crafted from PDS II (Polydioxanone), known for its biocompatibility and monofilament structure. The suture is mounted on a plastic applicator, facilitating precise ligation of tissue structures such as the appendix base, cystic duct, or vascular pedicles.

Key Features

• Material and Design: The suture is available in violet or undyed variants and comes in various sizes, ranging from USP 0 to 7/0. It offers lengths from 45 cm to 240 cm, accommodating different surgical needs. The applicator, made from Nylon 11 or Nylon 12, is available in lengths of 30.5 cm or 38 cm with an outer diameter of 3.9 mm.

• Absorption and Strength: The absorbable nature of the suture ensures complete absorption within 180 to 238 days, reducing the need for removal and minimizing foreign body reactions. It retains significant tensile strength over time, maintaining 50–80% at two weeks, 40–70% at four weeks, and 35–60% at six weeks, depending on the configuration.

• Sterility and Packaging: Each suture is sterile and intended for single use, supplied without a needle in the ENDOLOOP configuration. Packaging includes boxes of 12 units, ensuring readiness for multiple procedures.

Applications

The SUTURE PDS II ENDOLOOP is ideally suited for minimally invasive surgeries such as laparoscopic appendectomy, cholecystectomy, and various gynecological procedures. Its strong knot security and predictable handling characteristics make it suitable for deep tissue repairs, abdominal closures, and orthopedic applications where prolonged tissue support is beneficial.

Advantages

This device offers several advantages, including:

• Minimally Invasive Application: Allows for precise ligation with minimal surgical footprint.
• Predictable Absorption Profile: Ensures reliable performance over the healing period.
• High Biocompatibility: Reduces adverse tissue reactions, enhancing patient outcomes.

Regulatory Information

Classified as a Class III medical device under Council Directive 93/42/EEC, the SUTURE PDS II ENDOLOOP meets stringent regulatory standards, underscoring its quality and reliability in surgical settings.

Ethicon's commitment to innovation and quality is evident in this product, providing surgeons with a dependable tool for complex surgical environments. The SUTURE PDS II ENDOLOOP stands as a testament to advanced surgical technology, offering enhanced outcomes through superior design and material excellence.