DEFINISSE FREE FLOATING THREADS 12 cm RELIFE/ 6
DEFINISSE
Medical deviceResorbable barbed suspension threads for facial soft tissue repositioning
Certifications
- Class III resorbable synthetic surgical medical device under applicable European medical device legislation.
- CE Marked device (e.g., CE 0373) demonstrating conformity with essential requirements for safety and performance.
- Manufactured under an ISO 13485 Compliant Quality Management System (QMS) or equivalent medical device quality standard as implemented by RELIFE / Menarini.
- Supplied sterile with validated sterilisation and packaging processes, single Use only, with full traceability (reference, lot, EAN/UPC) for patient records.
- Professional Use Only product to be used according to local regulations governing medical devices and aesthetic medical procedures.
- Class III resorbable synthetic surgical medical device under applicable European medical device legislation.
- CE Marked device (e.g., CE 0373) demonstrating conformity with essential requirements for safety and performance.
- Manufactured under an ISO 13485 Compliant Quality Management System (QMS) or equivalent medical device quality standard as implemented by RELIFE / Menarini.
- Supplied sterile with validated sterilisation and packaging processes, single Use only, with full traceability (reference, lot, EAN/UPC) for patient records.
- Professional Use Only product to be used according to local regulations governing medical devices and aesthetic medical procedures.
Resorbable barbed suspension threads for facial soft tissue repositioning
Description
DEFINISSE FREE FLOATING THREADS -12 cm RELIFE/ 6 by RELIFE (Menarini Group) are sterile, resorbable, monofilament barbed suspension threads made of poly(L-lactide-co-ε-caprolactone) [P(LA-CL)]. These free floating threads are bidirectional and converging, with a notched (barbed) length of 12 cm, and are supplied in individual sterile pouches. Designed for REPOSITIONING FOR REJUVENATION, they are indicated for soft tissue repositioning and facial contour enhancement. As part of the DEFINISSE thread range, these threads provide minimally invasive lifting and revitalising effects by engaging soft tissues with their patented barbs, helping to lift and hold sagging tissues to refresh facial appearance and define contours. They are Class III synthetic surgical medical devices, CE-marked, and intended exclusively for professional use by physicians trained in facial thread techniques.
Bnefits
- Resorbable monofilament support threads designed to reposition and support soft tissues for facial rejuvenation.
- Bidirectional and converging barbs provide stable multidirectional tissue engagement for lifting and repositioning.
- Notched (barbed) length of 12 cm allows targeted use in specific facial areas requiring subtle repositioning.
- Unique, patented barbed suture design (length, density, angling of barbs) delivers both lifting and revitalising effects.
- Absorbable P(LA-CL) material offers a non-allergenic composition and avoids the need for thread removal.
- Supports a refreshed appearance and more defined facial contours by lifting soft, sagging tissues.
- Supplied in individual sterile pouches to facilitate aseptic handling and precise use in clinical settings.
- Can be combined with other DEFINISSE threads (ancorage and double needle) for tailored, multi-level facial remodelling plans.
- Minimally invasive technique that can provide natural-looking rejuvenation without traditional surgical facelift.
- Professional-only product ensuring that treatments are performed by trained specialists for safety and optimal outcomes.
Indications
- Soft tissue repositioning for facial rejuvenation (REPOSITIONING FOR REJUVENATION).
- Lifting and supporting mildly to moderately sagging facial tissues in suitable areas as determined by the physician.
- Refinement of facial contours (e.g., midface, jawline, lower face) where free floating bidirectional threads are appropriate.
- Adjunctive use alongside other aesthetic treatments (e.g., fillers, energy-based devices) as part of a comprehensive facial remodelling plan by trained professionals.
- Use in patients who are candidates for thread lifting but do not wish to undergo traditional surgical facelift procedures.
Composition
- Monofilament resorbable thread made of poly(L-lactide-co-ε-caprolactone) [P(LA-CL)], a synthetic, biocompatible copolymer.
- Bidirectional and converging barbs (notches) engineered along a 12 cm notched length for anchorage and lifting of soft tissues.
- Non-allergenic composition based on poly-lactic-caprolactone as described for DEFINISSE free floating threads.
- Sterile packaging materials (individual pouches and any internal supports) designed to maintain sterility and preserve thread integrity until use.
Formulation
- Class III resorbable synthetic surgical medical device (suture / support thread).
- Absorbable, monofilament, hanging barbed thread with bidirectional and converging barbs.
- Notched length: 12 cm for this specific product presentation.
- Material: poly(L-lactide-co-ε-caprolactone) [P(LA-CL)], also referred to as poly-lactic-caprolactone.
- Free floating threads: designed as support threads without fixed anchorage needles described in the product text; used for repositioning soft tissues via bidirectional barbs.
- Part of the DEFINISSE thread range, which also includes ancorage and double needle barbed threads.
- Supplied sterile, single-use only; must not be resterilised or reused.
Packaging
- Outer carton labelled as DEFINISSE FREE FLOATING THREADS -12 cm RELIFE/ 6.
- Contains 6 sterile resorbable barbed threads made of P(LA-CL), each in an individual sachet (bag).
- Carton includes product reference number 8033439173146 and EAN13 8033439173146, with UPC 90183900.
- Instructions for Use (IFU) included, with detailed information on indications, contraindications, insertion techniques, precautions and adverse events, intended for trained physicians.
- Labelling displays brand (RELIFE DEFINISSE MENARINI GROUP), CE marking (e.g., CE 0373), device class, sterile and single-use symbols, lot number and expiry date.
Usage
- For professional use only in a medical setting by physicians (e.g., dermatologists, plastic surgeons, aesthetic medicine specialists) who have completed specific training in DEFINISSE thread techniques and facial anatomy.
- Before use, read the full Instructions for Use (IFU) and verify package integrity, sterility and expiry date; do not use if the sterile barrier is compromised.
- Perform a complete patient assessment, including medical history, medications, contraindications, aesthetic goals and suitability for thread lifting.
- Obtain informed consent detailing benefits, risks, alternatives and post-procedure expectations.
- Cleanse and disinfect the treatment area thoroughly using appropriate antiseptic measures, and mark insertion points and trajectories according to the planned soft tissue repositioning vectors.
- Open the sterile sachet in an aseptic field and handle the thread using sterile gloves and instruments only.
- Introduce the free floating thread according to the technique described in the IFU (e.g., using an introducer needle or cannula system, depending on the specific configuration) to position the barbed segment within the soft tissue along predetermined vectors.
- Ensure that the bidirectional barbs are correctly oriented and engaged in the tissue so that soft tissues are held and repositioned in the desired direction.
- After placement, gently adjust tension and mould tissues externally as needed to refine contour and symmetry, following IFU guidance and clinical judgement.
- Provide the patient with written post-procedure instructions, including recommendations to avoid strenuous facial movements, massages, dental procedures, excessive heat/cold exposure and sleeping positions that may compromise threads for a specified period.
- Schedule follow-up appointments for assessment, management of potential adverse effects and evaluation of treatment outcomes.
- Use threads strictly once; discard any unused or partially used threads in accordance with local regulations for medical sharps and biohazard waste.
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.
- Presence of active infection, inflammation or dermatologic disease (e.g., acne, dermatitis, rosacea flare, herpes) at or near the intended treatment site.
- Systemic infection or significant systemic illness at the time of the planned procedure.
- Severe coagulation disorders, uncontrolled bleeding diathesis or anticoagulant / antiplatelet therapy where the risk of bleeding or bruising is considered unacceptable by the treating physician.
- History of keloid or hypertrophic scarring in areas planned for thread insertion, when the risk is deemed significant.
- Autoimmune or connective tissue disorders or other systemic conditions that significantly impair wound healing, unless a specialist determines use is appropriate.
- Pregnancy and breastfeeding, due to insufficient safety data for these populations in aesthetic thread-lift procedures.
- Patients with unrealistic expectations, body dysmorphic disorder or other psychological conditions that would make them unsuitable candidates for aesthetic procedures.
- Any general contraindication to minimally invasive aesthetic interventions as determined by the treating physician.
Adverse Effects
- Common local reactions such as pain, tenderness, erythema, swelling and bruising at insertion points and along the thread trajectory.
- Localised haematoma or ecchymosis due to blood vessel injury during insertion.
- Temporary irregularities, dimpling or puckering of the skin, particularly in early post-treatment stages.
- Palpable or visible threads, especially in patients with thin skin or superficial placement; may require massage, adjustment or, rarely, removal.
- Infection along the thread path or at entry/exit points, which may require antibiotics and, in some cases, thread removal.
- Foreign-body or inflammatory reactions, including nodules or granuloma-like formations, requiring medical evaluation and possible treatment.
- Thread migration, partial extrusion, or breakage necessitating corrective measures or removal.
- Neurovascular injury, such as temporary or persistent sensory changes or vascular compromise, if critical structures are inadvertently affected.
- Scarring or persistent changes in skin texture at insertion sites or along the thread course.
- As with all invasive aesthetic procedures, rare but serious complications can occur and must be managed promptly by experienced clinicians.
Storage Conditions
- Store in the original unopened packaging in a clean, dry environment at controlled room temperature as specified on the carton.
- Protect from direct sunlight, excessive heat, humidity and freezing temperatures to maintain device integrity.
- Do not use if the sterile packaging is opened, damaged or otherwise compromised.
- Do not resterilise or reuse; product is sterile and intended for single use only.
- Keep out of reach of unauthorised persons and in line with local regulations for storage of Class III medical devices.
Duration
Provides an immediate repositioning effect after placement, with clinical outcomes generally lasting many months while the P(LA-CL) threads remain structurally intact. Over time, the threads are resorbed and replaced by fibrous tissue, with duration of effect dependent on patient factors, treatment area, technique and lifestyle.
Onset
Immediate visible repositioning and lifting of soft tissues following correct placement and tensioning of the threads, with further refinement over the subsequent weeks as tissue adapts and fibrous support develops.
