SERAMON non-absorbable clear (4/0) HR-17 needle of 75 CM box of 24 sutures - Serag & Wiessner (MEO15341C) - Delynov

What is the non-absorbable SERAMON suture?

SERAMON is a synthetic, monofilament, and non-absorbable surgical suture material developed by the manufacturer Serag-Wiessner. This non-absorbable surgical thread is entirely composed of polytetrafluoroethylene (PTFE), a polymer recognized for its high biological inertness. Offered exclusively in a non-colored (colorless) version, it features a smooth surface that minimizes tissue trauma during thread passage. As a 4/0 monofilament suture, it avoids capillarity phenomena (wicking effect), thus reducing the risks of bacterial colonization along the suture thread. This device is packaged in boxes of 24 units to meet the needs of operating theaters and oral surgery practices.

What are the clinical indications for this suture thread?

This surgical suture is primarily indicated for soft tissue adaptation and performing ligatures in situations where a non-absorbable material is required by the practitioner. Its use extends to complex procedures, including interventions on the circulatory system and the central nervous system. In implant and periodontal surgery, the non-absorbable PTFE suture thread is appreciated for its dimensional stability and tissue tolerance. PTFE threads can also fulfill specific functions such as support threads or marking means during multi-stage surgeries. The choice of this 4/0 calibre with a 75cm needle allows for easy handling to secure flaps or stabilize tissue grafts.

What are the technical characteristics of the HR-17 needle?

The product MEO15341C is equipped with an HR-17 type needle. According to technical nomenclature, the code 'HR' designates a 1/2 circle round point needle, specifically designed for round needle surgical sutures. This geometry is ideal for deep sutures and ligatures, as the round point pushes tissues aside without cutting them, thus limiting bleeding at the puncture point. The number '17' indicates a needle body length of 17mm. Combined with a 75cm thread, this configuration offers the surgeon sufficient working length to perform several stitches or complex continuous sutures with constant precision, while ensuring fluid penetration into soft tissues.

What are the contraindications for the use of SERAMON?

The use of the SERAMON suture from Serag-Wiessner presents specific contraindications defined by the manufacturer. The device must absolutely not be used in patients with known or suspected allergies to any of its components, notably polytetrafluoroethylene (PTFE). Furthermore, the manufacturer specifies that there is not yet sufficient clinical experience to validate its use in microsurgery, ophthalmology, or for surgical interventions on peripheral nerves. It is therefore recommended that practitioners strictly comply with the intended indications and take into account the specific characteristics of the material before any implantation, in accordance with the instructions for use provided with the device.

How is the follow-up conducted for a non-absorbable PTFE suture?

As a 4/0 non-absorbable monofilament suture material, SERAMON does not undergo degradation by hydrolysis or enzymatic action in the body. It retains its tensile strength indefinitely, which is crucial for surgical sites subject to prolonged tension or requiring slow healing. Unlike absorbable sutures, this thread must be manually removed by the practitioner once clinical healing is achieved, unless it is used as a permanent support thread. During placement, particular attention must be paid to knot construction, as PTFE possesses a low friction coefficient. It is advisable to multiply the throws to ensure knot security and avoid any post-operative slippage.

Who is the manufacturer and what standards are respected?

The SERAMON suture is manufactured by Serag-Wiessner GmbH & Co. KG, a recognized manufacturer located in Naila, Germany. This medical device is classified as Class III, which corresponds to the highest regulatory requirement level for implantable devices. It benefits from the CE1014 marking, guaranteeing its compliance with the safety and performance requirements of the European Union. The suture materials comply with the European Pharmacopoeia (Ph. Eur.) monograph relating to sterile non-absorbable suture materials (fila non resorbilia sterilia). This compliance ensures dental surgeons and implantologists a high-quality, sterile, and rigorously controlled product for their daily surgical interventions.

State of the art

Modern synthetic sutures - absorbable or non-absorbable - are central to wound healing in oral surgery. Recent advances focus on reducing post-operative infections.