The Foqus PGCL 5.0 Circular Needle 5 Piece set is a highly specialized medical-surgical product, designed to offer safety, precision and reliability during suturing procedures. This set includes five circular needles equipped with 5.0 gauge PGCL (Poliglecaprone 25) thread, a type of absorbable synthetic suture material appreciated in surgery for its excellent mechanical properties and post-operative management. Ideal for operations on delicate tissues that require a minimally traumatic approach, the set ensures high performance in both outpatient and hospital settings. Circular needles offer smooth passage through tissue, minimizing the risk of damage and ensuring optimal aesthetic results. Each component of the set is made to maintain stability and reduce wire memory, allowing easy handling even in high precision situations. The five-piece package makes the Foqus PGCL 5.0 set particularly convenient for surgeons and healthcare workers who wish to procure ready-to-use sterile instruments, underlining their practicality both for single procedures and for intensive use in operating rooms and veterinary or human clinics.
Therapeutic Indications
The Foqus PGCL 5.0 suture set with circular needle is indicated for closing surgical incisions, suturing soft tissues and making internal stitches in numerous branches of medicine, such as general, plastic, aesthetic, gynecological and veterinary surgery. The PGCL material is particularly recommended for applications where temporary resistance of the thread is required which allows the time necessary for the physiological healing of the tissue, without the need for subsequent removal. It is also used in minimally invasive procedures in which the low traumatic capacity of the needle and the softness of the thread reduce inflammatory reactions to a minimum and facilitate rapid post-surgery recovery. The use of circular needles ensures precise penetration into the tissues and minimizes the risk of lacerations, while the 5.0 calibration guarantees an optimal balance between suture tightness and flexibility, allowing effective closure even of anatomical areas that are difficult to access. Recommended for subcutaneous sutures, reconstructive plastic closures, intestinal and urological anastomoses, as well as in various emergency situations where the speed and effectiveness of the repair are fundamental to avoid future complications and ensure optimal healing evolution.
Composition
Active ingredient: The suture material contained in Foqus PGCL 5.0 Circular Needle is made up of Poliglecaprone 25, a monofilament synthetic fiber subjected to advanced sterilization to ensure maximum safety of use. This polymer is the result of a copolymerization between glycolide and ε-caprolactone, which gives the thread excellent mechanical properties, high levels of initial elasticity and progressive loss of resistance proportionate to the tissue healing process.
Needles: Each needle is made of high-strength surgical steel, designed to maintain its sharpness and offer gentle yet effective penetration. The circular shape is ideal for piercing and separating tissues without cutting them, promoting precise closure and reducing the possibility of secondary damage.
Excipients: Not applicable for medical devices of this type. Each set is packaged in a sterile atmosphere and latex-free, to minimize allergic reactions and increase patient safety.
Contraindications
The use of PGCL sutures is contraindicated in patients who exhibit known hypersensitivity or allergy to the synthetic materials (Poliglecaprone 25) used in the device. The set must not be used for procedures that require prolonged retention of the material, where mechanical support is necessary beyond the period of maximum resistance of the wire (which normally reduces significantly in the weeks following implantation). It is also not recommended in tissues or in areas of high tension where the risk of dehiscence is high, such as muscle bundles in tension or segments subject to considerable mechanical stress. Do not use on patients with immunodeficiency conditions or in the presence of serious local infections, since the accelerated degradation of the thread could lead to insufficient sealing of the suture or complications following inflammatory reactions. Avoid use in ocular procedures or cardiovascular tissues, unless specifically indicated by the experienced surgeon. In case of adverse events such as swelling, persistent pain, redness or discharge from the suture site, contact medical personnel promptly.
Safety of the drug for the species
The Foqus PGCL 5.0 Circular Needle is designed to guarantee maximum safety both in the human patient and in the veterinary field, thanks to its characteristics of reabsorbability and documented biocompatibility. The risk of adverse reactions is minimized thanks to the selection of hypoallergenic materials and rigorous sterility control during production. However, as with any medical suturing device, there is no possibility of completely excluding local inflammatory reactions or individual hypersensitivity reactions. The gradual nature of reabsorption modulates the loss of mechanical resistance, limiting the possibility of wound dehiscence and generating conditions favorable to the orderly healing of tissues. In any case, the doctor/surgeon must monitor the state of the suture, regularly checking the integrity of the material until its complete biodegradation. The risks deriving from cross-contamination or nosocomial infections are reduced to a minimum, thanks to the sterile packaging of every single needle and thread. The safety of use also extends to pediatric patients and fragile subjects, as long as the appropriate clinical indications and individual assessment of the case are respected.
Precautions
When handling Foqus PGCL 5.0 Circular Needle 5 Pieces, it is necessary to adopt the usual precautions typical of sterile and surgical environments: wear sterile disposable gloves, avoid contact of the suture material and needles with non-sterile surfaces to preserve sterility until use. Do not reuse sutures or needles under any circumstances to prevent possible contamination. Pay attention to the correct storage of the packages in a dry place protected from direct light, maintaining the room temperature and periodically checking that the integrity of the package is intact until opening. Do not use in case of damaged packaging. Make sure each needle is assembled correctly before use to avoid risks of breakage or intraoperative malfunctions. Promptly inform the personnel in charge if the validity of the product is approaching or has reached its expiry date. After use, dispose of needles and thread in sharps containers in accordance with current regulations regarding medical waste to prevent accidents and infectious transmission. Be careful when handling and pulling the wire to reduce the risk of unwanted breakage; use suitable tools when positioning and knotting the sutures. If administered to pediatric patients, carefully evaluate the risk/benefit balance, taking into account the general conditions and the type of intervention.
Method of administration
To correctly use Foqus PGCL 5.0 Circular Needle 5 Pieces, carefully remove the device from the sterile packaging only when you are ready to use it during surgery. Use aseptic techniques when handling the set, avoiding accidental contamination. Each circular needle is to be used according to the surgical suturing techniques indicated for the tissue and type of lesion to be repaired, using the PGCL thread in order to create efficient and well-distributed stitches, capable of supporting the physiological traction of the wound edges. The choice of the suturing technique, the distance between the stitches and the type of knot must be adapted to the specific clinical need, evaluating the depth and tension of the affected tissue. The thread must be passed delicately, avoiding excessive twisting or stretching which could compromise its tightness or cause damage to the sutured edges. Once the operation is completed, check the stability of the knots and make sure that no residues of steel material remain in the tissues. Dispose of waste material respecting safety procedures.
Treatment program
The Foqus PGCL 5.0 Circular Needle 5 Piece set is intended for single use only and adaptable to the extent and complexity of the surgical procedure undertaken. The duration of the presence of the suture in the tissue is regulated by the natural enzymatic degradation of the PGCL, which ensures adequate resistance for the first two weeks following implantation and gradual dissolution in the following weeks. The replacement or removal interval is not required, as it is a totally absorbable product; however, based on the extent of the lesion or incision, the doctor can schedule periodic checks to monitor the correct evolution of the healing and the possible onset of complications. For multiple interventions or on large surfaces, the use of multiple sets in succession can be foreseen as needed. The product is designed to guarantee operational continuity for the surgeon, thanks to the five pieces available in the package, which can be used consecutively without the need for changes during the same procedure, increasing the efficiency and speed of the operation.
Target species
The Foqus PGCL 5.0 Circular Needle 5 Pieces is suitable for use on human and animal patients, making it perfect for both general hospital surgery and applications in routine or specialist veterinary medicine. In the case of veterinary medicine, it can be used on dogs, cats and other domestic animals for cutaneous and subcutaneous sutures, orthopedic or reconstructive operations, as well as in companion and farm animal medicine in situations where safe healing is required and with minimal risk of tissue reaction. In the human context, the product finds application in interventions on adult and pediatric patients, thanks to the flexibility, delicacy and safety offered by the material. Before each use, the individual assessment of the clinical conditions and anatomical particularities must always be carried out by qualified medical or veterinary personnel.