CE 2292 marking for the countourel portfolio of resorbable PDO threads (Croma Pharma)
Medical device classified and marketed in the EU/EEA under applicable medical device regulations for resorbable PDO threads
CE 2292 marking for the countourel portfolio of resorbable PDO threads (Croma Pharma)
Medical device classified and marketed in the EU/EEA under applicable medical device regulations for resorbable PDO threads
Nose tip lifting PDO thread (tensor thread)
Description
Countourel Jamber Tanxing 23G L / 60mm is a CE-marked, coiled (spiral) absorbable PDO lifting thread specifically designed for minimally invasive aesthetic reshaping of the nose. The thread has optimized elasticity for treating the nasal tip and is preloaded on an L-shaped 23G cannula (60 mm) to allow precise vertical placement and controlled lifting of the nose tip and nasal bridge. Supplied as a professional-use medical device, it is indicated for trained healthcare professionals performing non-surgical nose contouring procedures.
Bnefits
Coiled (spiral) thread specialized for lifting and reshaping the nose tip
Optimized elasticity designed for targeted treatment of the nasal tip region
Enables minimally invasive reshaping of the nose with no surgical rhinoplasty
Allows heightening and straightening of the nasal bridge and refining nasal contour
Absorbable PDO thread that provides structural support while stimulating collagen
CE-marked medical device within the countourel PDO thread portfolio
Supplied on an L-shaped cannula to facilitate accurate vertical placement and controlled lifting
Indications
Minimally invasive aesthetic reshaping of the nose
Nose tip lifting procedures
Heightening and straightening of the nasal bridge
Refinement and reshaping of the nasal tip contour in suitable patients
Adjunct to non-surgical rhinoplasty techniques performed by trained medical professionals
Each thread supplied preloaded on an L-shaped 23G, 60 mm cannula
Single-use sterile packaging to reduce contamination risk and maintain stability until opening
Usage
For professional use only: implantation must be performed exclusively by trained and qualified healthcare professionals experienced in PDO thread techniques and nasal procedures.
Use in accordance with the manufacturer’s Instructions for Use (IFU) and local regulations for medical devices.
Select appropriate patients after full medical history, examination, and informed consent, ensuring indication suitability for minimally invasive nasal reshaping.
Prepare and disinfect the nasal treatment area following standard aseptic technique and institutional protocols.
Insert the L-shaped 23G, 60 mm cannula according to the IFU, typically with vertical placement patterns suited for nose tip lifting and nasal bridge contouring.
Adjust thread position to lift and support the nasal tip and/or bridge as planned; then withdraw the cannula while leaving the PDO thread in place.
Gently contour and smooth the treated area externally, according to professional judgement, to optimize final nose shape.
Dispose of all used cannulas and packaging as medical sharps/waste in accordance with local regulations.
Provide patients with post-procedure care instructions (e.g., avoiding trauma, excessive pressure, or strenuous activity around the nose as recommended in the IFU).
Contraindications
Use in patients who are unsuitable for minimally invasive thread lifting procedures as determined by a qualified healthcare professional.
Active or local infection, inflammation, or skin disease at or near the intended insertion sites.
Known hypersensitivity or allergy to PDO (polydioxanone) or any component of the device.
Severe coagulation disorders or current clinically significant anticoagulant/antiplatelet therapy that cannot be managed appropriately for the procedure.
Uncontrolled systemic disease or significant autoimmune/connective tissue disorders where wound healing may be impaired, as assessed by the treating physician.
Pregnancy and breastfeeding, unless the treating physician determines otherwise in line with local guidelines and risk–benefit assessment.
History of keloid or hypertrophic scarring where thread implantation may pose additional risk, at the discretion of the practitioner.
Any contraindications or warnings listed in the official Instructions for Use supplied by the manufacturer.
Adverse Effects
Common, usually transient reactions such as localized pain, tenderness, erythema, swelling, or bruising at the insertion sites.
Minor bleeding or hematoma formation along the cannula or thread trajectory.
Temporary asymmetry, irregularity, or palpability of the thread, which may improve as tissues settle and heal.
Risk of infection at the insertion sites if aseptic technique or aftercare is inadequate.
Inflammatory reactions, nodules, or dimpling in the treated area.
In rare cases, more significant complications may occur, such as thread migration, extrusion, or prolonged pain; all potential risks and adverse events should be consulted in the manufacturer’s IFU and managed by a qualified healthcare professional.
Storage Conditions
Store in accordance with the manufacturer’s Instructions for Use and local regulations for sterile medical devices.
Keep in the original, sealed sterile packaging until immediately before use.
Protect from excessive heat, moisture, and direct sunlight; avoid freezing.
Do not use after the expiry date printed on the packaging.
Do not use if the sterile blister or outer packaging is opened, damaged, or compromised.
Duration
Clinical effects from Jamber PDO threads are typically reported to last around 12\u201318 months, depending on patient factors, technique, and indication.
Onset
An immediate mechanical lifting and contouring effect is usually visible after thread placement, with additional progressive improvement over the following weeks due to collagen stimulation as the PDO thread is gradually resorbed.
