DEFINISSE DOUBLE NEEDLES THREADS 23 cm RELIFE/ 6
DEFINISSE
Medical deviceResorbable barbed suspension threads for facial soft tissue lifting and contouring
Certifications
- Class III resorbable synthetic surgical medical device under applicable European medical device regulations.
- CE Marked device (e.g. CE 0373) indicating conformity with relevant safety and performance standards for medical devices.
- Manufactured under a certified Quality Management System compliant with medical device standards such as ISO 13485.
- Supplied sterile with validated sterilisation and packaging processes and with appropriate traceability labelling (reference, lot number, EAN/UPC).
- Professional Use Only product, to be employed in accordance with local regulations governing medical devices and aesthetic medical procedures.
- Class III resorbable synthetic surgical medical device under applicable European medical device regulations.
- CE Marked device (e.g. CE 0373) indicating conformity with relevant safety and performance standards for medical devices.
- Manufactured under a certified Quality Management System compliant with medical device standards such as ISO 13485.
- Supplied sterile with validated sterilisation and packaging processes and with appropriate traceability labelling (reference, lot number, EAN/UPC).
- Professional Use Only product, to be employed in accordance with local regulations governing medical devices and aesthetic medical procedures.
Resorbable barbed suspension threads for facial soft tissue lifting and contouring
Description
DEFINISSE DOUBLE NEEDLES THREADS -23 cm by RELIFE (Menarini Group) are sterile, resorbable, monofilament barbed suspension sutures made of poly(L-lactide-co-ε-caprolactone) [P(LA-CL)]. Each support thread has bidirectional, converging notches (barbs) along a 23 cm notched segment and is mounted at both ends on straight stainless-steel needles for insertion. These Class III medical devices are designed for remodeling and lifting of the malar area, jawline and facial oval, providing a rapid, minimally invasive and natural-looking tissue repositioning option for patients with moderate facial sagging, without resorting to traditional surgical facelift. Threads are supplied as six individually pouched sutures per box and are intended exclusively for use by trained medical specialists in facial thread-lift techniques.
Bnefits
- Resorbable monofilament barbed threads designed to lift and support sagging facial soft tissues.
- Bidirectional and converging notches along a 23 cm notched segment provide strong and stable tissue engagement in opposing directions.
- Dual straight-needle configuration (one needle at each end of the thread) facilitates converging vector placement and secure anchoring.
- Provides immediate mechanical lifting with progressive tissue remodelling during thread resorption.
- Allows contour remodelling of the malar region, jawline and facial oval without traditional open surgery.
- Biodegradable P(LA-CL) material avoids the need for suture removal and is gradually replaced by fibrous tissue.
- Unique and patented suture design with barbs optimised in length, density and angle to deliver both lifting and revitalising effects.
- Supplied sterile in individual sachets for each thread, supporting aseptic technique in clinical practice.
- Part of the DEFINISSE thread portfolio, allowing personalised treatment plans in combination with ancorage and free-floating threads.
- EASY HANDLING AND QUICK RESULTS when used by appropriately trained aesthetic physicians.
Indications
- Remodelling and lifting of soft tissues in the malar (midface) areas.
- Remodelling and lifting along the jawline.
- Redefinition of the facial oval (lower-face contour).
- Treatment of moderate facial soft-tissue ptosis suitable for minimally invasive thread-lift procedures.
- Professional use in aesthetic medicine, dermatologic surgery and plastic surgery settings for facial soft-tissue suspension and contouring.
Composition
- Monofilament resorbable support thread made of poly(L-lactide-co-ε-caprolactone) [P(LA-CL)], a synthetic, biocompatible copolymer.
- Bidirectional and converging barbs (notches) engineered along a 23 cm central segment of the thread to grip soft tissues.
- Two straight stainless-steel needles (one at each end of the support thread) for insertion and passage through tissues; for the 23 cm notched length version, needle length is approximately 150 mm each as per range specifications.
- Sterile medical-grade packaging materials (individual pouches / trays) designed to maintain sterility and protect the needles and thread configuration.
Formulation
- Class III resorbable synthetic surgical medical device (suture / suspension thread).
- Monofilament barbed support thread with bidirectional, converging notches (cogs) along a 23 cm notched segment.
- Material: poly(L-lactide-co-ε-caprolactone) [P(LA-CL)].
- Bi-directional barbs oriented to provide opposing traction and stabilisation of lifted tissue.
- Each end of the thread is equipped with a straight stainless-steel needle for converging insertion paths.
- Absorbable over time, with mechanical support gradually diminishing as the polymer is resorbed and replaced by fibrous tissue.
- Supplied sterile and intended for single use only; must not be resterilised or reused.
Packaging
- Box containing 6 sterile DEFINISSE Double Needles support threads.
- Each thread is packaged in an individual sterile sachet / pouch, often mounted in a protective tray for safe handling and preservation of curvature.
- Outer carton labelled with product name (DEFINISSE DOUBLE NEEDLES THREADS -23 cm RELIFE/ 6), brand (RELIFE DEFINISSE MENARINI GROUP), reference number 8033439173139, EAN13 8033439173139 and UPC 90183900.
- Package insert / Instructions for Use (IFU) included, describing indications, contraindications, warnings, insertion technique and post-procedure guidance for trained physicians.
- Labelling indicates CE marking (e.g. CE 0373), device class (Class III), sterile status, single-use symbol, lot number and expiry date.
Usage
- For professional use only by physicians (e.g. dermatologists, plastic surgeons, aesthetic medicine specialists) trained and experienced in facial thread-lift techniques and anatomy.
- Before use, read the Instructions for Use (IFU) carefully and verify package integrity, sterility indicator, lot number and expiry date.
- Assess the patient’s medical history, indications and expectations; obtain informed consent including discussion of benefits, risks, alternatives and post-treatment care.
- Mark insertion and exit points and desired lifting vectors on the cleansed skin in the malar, jawline and facial oval areas, following the IFU and clinical judgement.
- Prepare the treatment area using appropriate antiseptic measures and maintain strict aseptic technique throughout the procedure.
- Open the sterile pouch and handle the thread and needles using sterile gloves and instruments only.
- Insert each straight needle according to the recommended technique, creating converging bidirectional paths to achieve mechanical lifting and anchorage of the soft tissue.
- After placement, adjust thread tension to achieve the desired lifting effect, then cut and position the thread ends in accordance with the IFU.
- Provide post-procedure instructions, such as avoiding vigorous facial movements, massage or pressure on the treated areas for a specified period, sleeping on the back, and avoiding extreme temperatures or strenuous exercise according to clinic protocol.
- Schedule follow-up visits to monitor healing, assess results and manage any adverse reactions or complications as necessary.
Contraindications
- Known hypersensitivity or allergy to poly(L-lactide-co-ε-caprolactone) [P(LA-CL)], polylactic acid, ε-caprolactone or any component of the device.
- Active or localised infection, inflammation or skin disease (e.g. acne, dermatitis, cellulitis, herpes) in or near the intended treatment area.
- Systemic infection, febrile illness or significant systemic inflammatory diseases at the time of treatment.
- Severe coagulation disorders, uncontrolled bleeding diathesis or use of anticoagulant / antiplatelet therapy when the risk is considered unacceptable by the treating physician.
- History of keloid or hypertrophic scarring in the areas to be treated, where thread placement may increase risk.
- Autoimmune or connective tissue diseases and other conditions that significantly impair wound healing, unless deemed appropriate by the treating physician.
- Pregnancy and breastfeeding, due to lack of sufficient safety data, unless otherwise allowed by local regulations and physician judgement.
- Patients with unrealistic expectations, psychological disorders (such as body dysmorphic disorder) or other factors making them unsuitable candidates for aesthetic thread-lift procedures.
- Any general contraindication to minimally invasive aesthetic procedures as determined by the treating physician.
Adverse Effects
- Common, usually transient post-procedure reactions such as pain, tenderness, swelling, bruising and erythema at insertion and along the thread path.
- Localised haematoma or ecchymosis due to vascular puncture during needle passage.
- Temporary irregularities, dimpling, puckering or asymmetry in the treated area, especially in the early post-treatment period.
- Palpable or visible threads or barbs under the skin, which may require massage, adjustment or, in rare cases, removal.
- Infection at the insertion sites or along the thread trajectory, which may require antibiotic treatment and/or thread removal.
- Inflammatory or foreign-body reactions, including nodules or granuloma-like reactions, that may necessitate medical management.
- Thread migration, extrusion or breakage, potentially requiring corrective procedures.
- Neurovascular injury (e.g. nerve irritation or vessel damage) if anatomical structures are inadvertently compromised during insertion.
- Scarring or persistent changes in skin texture at entry / exit points or along the thread course.
- As with all invasive aesthetic procedures, rare but serious complications may occur and require prompt expert evaluation and treatment.
Storage Conditions
- Store in the original unopened packaging in a clean, dry place at controlled room temperature as specified on the carton.
- Protect from extremes of temperature, moisture and direct sunlight to maintain material properties and packaging integrity.
- Do not use if the sterile barrier packaging is damaged, opened or shows signs of compromise.
- Do not resterilise or reuse; product is sterile and intended for single use only.
- Keep out of reach of unauthorised persons and store in accordance with local regulations for medical devices.
Duration
Provides an immediate lifting and contouring effect after insertion; the mechanical support and aesthetic results typically persist for many months while the P(LA-CL) threads remain structurally intact, with duration influenced by patient factors, treatment area and technique. The threads are gradually resorbed over time, with clinical effects decreasing progressively.
Onset
Immediate lifting and remodelling of the treated facial areas upon correct placement and tensioning of the threads, with additional refinement over subsequent weeks as tissue adaptation and fibrous encapsulation occur.
