What are the clinical indications and intended use?

SERAFIT from Serag-Wiessner is intended for surgical suturing and tissue closure. More specifically, the ligatures are used to close hollow organs. In dental and oral surgery, this material is suitable for procedures requiring tissue maintenance by an absorbable suture. The manufacturer specifies that the choice of material must be made by the user based on the required surgical techniques and the in vivo characteristics of the thread. This device is particularly indicated for interventions where natural absorption of the material is desired after the initial healing phase, thus avoiding a second intervention for stitch removal.

What are the contraindications for the use of this device?

The use of the SERAFIT suture is subject to important restrictions to ensure patient safety. It must not be used when stability of the suture material is required over a prolonged or long-term duration. Furthermore, this device is formally contraindicated in patients with known allergies to any of the product components, notably glycolic acid, calcium stearate, or polycaprolactone. The manufacturer also emphasizes that the use of absorbable sutures may prove inadequate in certain specific clinical contexts, making a prior assessment by the practitioner essential according to the patient's health status.

How does absorption occur and what are the precautions?

The absorption of SERAFIT occurs by hydrolysis in the tissues, transforming the polymer into glycolic acid which is then metabolized by the body. This process results first in a reduction of tension, then in a loss of mass of the thread. In vitro, the breaking strength loses approximately 60% of its initial value after 14 days. Total absorption is generally completed after approximately 90 days in vivo. Special precautions must be taken in patients with delayed healing or in tissues with low blood supply, as suture extrusion or delayed absorption are possible. It is recommended to read the instructions carefully before use.

SERAFIT absorbable violet (4/0) HR-17 needle 70 CM box of 24 sutures - Serag & Wiessner (6O153276) - Delynov

Q: What is the SERAFIT absorbable violet (4/0) suture?

The SERAFIT suture developed by Serag-Wiessner is a synthetic and absorbable surgical suture material. This medical device is presented as a braided multifilament, designed from a homopolymer of glycolic acid. To optimize its handling properties, the thread can be coated with calcium stearate with polycaprolactone or polyglycolic acid. This specific model has a 4/0 (USP) calibre and a thread length of 70 cm, packaged in a box of 24 units. Its braided structure ensures excellent flexibility during surgical handling, while its synthetic composition guarantees a predictable tissue reaction for practitioners in oral surgery and implantology.

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

The SERAFIT suture (reference 6O153276) is equipped with a technical needle of the HR-17 type. According to the nomenclature, the HR code designates a 1/2 circle round-bodied needle, specifically indicated for performing deep sutures and ligatures. The number 17 indicates a needle length of 17 mm. This configuration is ideal for the restricted spaces of the oral cavity, allowing dental surgeons increased precision when passing through soft tissues. The combination of a 70 cm thread and a 17 mm needle offers an optimal balance for various flap closure or periodontal surgery procedures.

Q: Who is the manufacturer and what standards are respected?

This suture is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. This medical device is classified as Class III, which corresponds to the highest level of regulatory requirement for surgical devices. It bears the CE1014 marking, attesting to its compliance with current European standards. As a high-tech product distributed by Delynov, SERAFIT meets the strict safety and performance requirements for implantable medical devices. Healthcare professionals must comply with the manufacturer's instructions and master the appropriate surgical techniques for the use of this synthetic absorbable suture material.

The SERAFIT suture by Serag-Wiessner GmbH & Co. KG is a monofilament synthetic medical device designed for progressive absorption in oral, periodontal, and implant surgery.

Absorption: Rapid, progressive absorption by hydrolysis.
Needle: HR-17 (17 mm), 1/2 circle, round tip.
Format: Thread length 70 cm, caliber 4/0 (USP).
Packaging: Box of 24 single-use sterile sutures.
Compliance: Medical device Class III, CE marking CE1014.
Manufacturer: Serag-Wiessner GmbH & Co. KG.

212.78 € 212.78 EUR 212.78 € Tax Included

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Sutures

What is the SERAFIT absorbable violet (4/0) suture?

SERAFIT from Serag-Wiessner is a synthetic, absorbable, multifilament surgical suture material. Its braided structure is composed of a glycolic acid homopolymer, offering flexible handling and knot security. This 4/0 calibre device comes in a violet color for optimal visibility during the operative procedure. Packaged in boxes of 24 units, this 70cm thread is a technical choice for practitioners looking for a reliable absorbable suture purchase. As a Class III device with CE1014 marking, it meets European safety requirements for temporary surgical implants.

What are the clinical indications for this suture?

This dental surgical suture is primarily indicated for soft tissue approximation and performing ligatures. In oral surgery and implantology, it is used to close extraction sites, secure flaps after implant placement, or during guided bone regeneration procedures. The manufacturer Serag-Wiessner specifies that SERAFIT is also suitable for closing hollow organs. Its use is relevant in clinical situations where natural resorption by the body is preferable to manual removal of the threads, thus facilitating post-operative follow-up in dental surgery.

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

The HR-17 needle equipping this SERAFIT suture has specific features for deep tissues. The 'HR' code designates a 1/2 circle round-bodied needle, a geometry designed to pass through tissues without excessive cutting effect, ideal for deep sutures and ligatures. The number '17' indicates a body length of 17 mm. This configuration is particularly suited to the restricted spaces of the oral cavity, allowing the surgeon to perform precise passes with a 1/2 circle curvature. It constitutes a technical alternative for practitioners accustomed to using an Optime equivalent in terms of maneuverability and dimensions.

What are the contraindications for the use of SERAFIT?

The use of SERAFIT from Serag-Wiessner involves specific contraindications defined by the manufacturer Serag-Wiessner GmbH & Co. KG. It must not be used when prolonged or permanent mechanical stability of the suture material is required, as its strength decreases progressively by hydrolysis. Furthermore, this device is strictly contraindicated in patients with a known allergy to any of its components, including glycolic acid or coating agents such as calcium stearate. Particular caution is recommended for patients with delayed healing or poor blood supply to the tissues, as this may lead to suture extrusion or delayed resorption.

How does resorption occur and what are the precautions?

Resorption of SERAFIT occurs by hydrolysis in the tissues, transforming the polymer into metabolizable glycolic acid. This process first results in a loss of tension: the breaking strength drops by approximately 60% compared to its initial value after 14 days (in vitro). Resorption of the thread mass is generally complete after approximately 90 days under in-vivo conditions. The practitioner must take these characteristics into account when choosing the material. It is advised to use this thread with caution in poorly vascularized areas. The user must imperatively master appropriate surgical techniques, as requirements vary according to the chosen clinical indication.

Who is the manufacturer and what standards are respected?

The SERAFIT suture is manufactured by Serag-Wiessner GmbH & Co. KG, a recognized manufacturer based in Germany. This medical device is classified as Class III, which corresponds to the highest level of requirement for implantable devices. It benefits from the CE1014 marking, guaranteeing its compliance with European safety and performance standards. Reference 6O153276 precisely identifies this 70cm model with HR-17 needle. Compliance with these strict standards ensures dental surgeons and implantologists a high-quality product for their daily dental surgery interventions, guaranteeing traceability and safety for the patient.

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.

Specifications

Manufacturer

Serag-Wiessner Suture Materials

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