SERALENE non-absorbable blue (6/0) HR-12 needle of 75 CM box of 24 sutures - Serag & Wiessner (LO07340C) - Delynov

What is SERALENE non-absorbable blue (6/0) suture?

SERALENE from the brand Serag-Wiessner is a synthetic and non-absorbable surgical suture material. This device is presented as a monofilament made from polyvinylidene fluoride. Its monobloc structure gives it a smooth surface, limiting bacterial adhesion and facilitating passage through tissues. For increased visibility during the operative act, the thread is dyed blue (solvent blue, colour index nº 61568). This specific model has a USP 6/0 calibre and a thread length of 75cm, packaged in boxes of 24 units under reference LO07340C.

What are the clinical indications for this device?

This blue non-absorbable suture is intended for soft tissue approximation or for performing ligatures requiring permanent support. Its mechanical properties and biocompatibility allow its use in high-precision fields such as microsurgery, ophthalmology, as well as for interventions on the central circulatory and nervous systems. In oral and implant surgery, it is particularly suited to periodontal microsurgery techniques where the finesse of the 6/0 calibre is required. Polyvinylidene fluoride threads can also be used as stay sutures or as marking means during specific procedures.

What are the technical characteristics of the HR-12 needle?

The SERALENE 6/0 suture is equipped with a technical needle referenced HR-12 by Serag-Wiessner. According to the nomenclature, the HR code designates a 1/2 circle curvature needle with a round point. This specific profile is particularly indicated for deep sutures and ligatures, allowing precise penetration without excessive cutting effect on the surrounding soft tissues. The number 12 indicates a needle length of 12 mm, which, combined with the 6/0 calibre, makes it a choice instrument for delicate interventions requiring high maneuverability in restricted spaces.

What are the contraindications for using this suture?

The use of SERALENE is formally contraindicated in patients with a known allergy to polyvinylidene fluoride or to the solvent blue dye (nº 61568). As with any implanted foreign body, the manufacturer specifies that prolonged contact of this device with the biliary or urinary tracts can promote the formation of calculi. The choice of this material must always result from an analysis of the technical characteristics of the thread in relation to the specific requirements of the surgical technique employed and the healing needs of the patient.

What are the precautions related to the non-absorbable nature of the thread?

Being a non-absorbable suture, SERALENE does not undergo degradation by hydrolysis or proteolysis. It maintains its mechanical strength over the long term. During implementation, the surgeon must take into account the specificities of the monofilament for knot construction to ensure their security. This material complies with the requirements of the European Pharmacopoeia for sterile non-absorbable sutures (fila non resorbilia sterilia). Unlike absorbable threads, a subsequent intervention may be necessary for the removal of stitches, except in cases where the thread is used as permanent support for body structures.

Who is the manufacturer and what standards are respected?

This medical device is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. The product benefits from a Class III regulatory classification, corresponding to the most strictly controlled implantable medical devices. It complies with current European standards, as evidenced by its CE1014 marking. Manufacturing respects the monographs of the European Pharmacopoeia concerning non-absorbable sutures. Each box of 24 sutures is delivered sterile and ready to use, guaranteeing optimal traceability and safety for complex 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.