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COUNTOUREL BARBED 19G W 90mm (16 pcs)

COUNTOUREL BARBED 19G W 90mm (16 pcs)

Countourel

Aesthetic medical device
  • Part of the Countourel CE 2292 PDO thread portfolio from Croma Pharma.
  • Class III CE Marked medical device for aesthetic tissue elevation.
  • Manufactured to meet European Medical Device Regulation (MDR) requirements, including MDR compliance highlighted in distributor information.
  • Individually blister Packed threads to reduce contamination risk and maintain product stability after opening the box.
  • Intended solely for use by trained healthcare professionals in accordance with applicable regulations and clinical guidance.
Absorbable PDO barbed lifting threads

Description

COUNTOUREL BARBED 19G W / 90mm (16 pcs) are absorbable polydioxanone (PDO) barbed tensor threads from the Countourel portfolio by Croma-Pharma. Each sterile, single-use device consists of a PDO thread with molded notches arranged as spiral 360° cogs, preloaded on a 19G W-shaped 90 mm cannula. The barbed design provides strong anchoring, fixation and tissue elevation, making these threads suited for non-surgical lifting, scaffolding and repositioning of facial and body tissues. They are commonly used for lifting of the middle and lower third of the face, facial and body contour correction, and eyebrow elevation. Countourel threads are part of Croma’s CE 2292 PDO thread range, manufactured in compliance with the EU Medical Device Regulation (MDR) and intended strictly for use by trained healthcare professionals.

Bnefits

  • Spiral 360° molded cogs provide strong anchoring, fixation and tissue elevation.
  • Designed for scaffolding and repositioning of soft tissue in aesthetic procedures.
  • Absorbable PDO threads enable non-surgical lifting of face and body areas.
  • Provides immediate mechanical tightening and lifting once implanted.
  • Helps improve facial contours in the mid and lower face, jawline and neck when used appropriately.
  • Suitable for eyebrow elevation and selected body contouring applications.
  • High tensile strength and optimized notch design enhance lifting capacity and durability of results.
  • Unique molding technology produces stable, durable notches with even distribution for consistent performance.
  • Individually blister-packed cannula threads help reduce contamination risk and improve handling.
  • Manufactured in compliance with MDR requirements, within a CE 2292 PDO thread portfolio from an established aesthetic manufacturer.

Indications

  • Non-surgical lifting and repositioning of sagging tissues in the middle and lower third of the face.
  • Facial contour correction, including jawline definition and lower facial reshaping, as judged appropriate by the treating practitioner.
  • Lifting and tightening of selected neck and lower face areas.
  • Facial and body contouring in suitable body regions as part of an individualized treatment plan.
  • Eyebrow elevation and lateral brow lift when performed with appropriate technique by a trained professional.
  • Creation of a subcutaneous support and scaffolding effect to improve skin firmness and facial structure.

Composition

  • Thread material: polydioxanone (PDO), a biodegradable synthetic polymer widely used in surgical sutures.
  • Thread type: barbed PDO thread with molded notches using 360° spiral thread technology for tissue fixation.
  • Cannula: W-shaped cannula, gauge 19G, length 90 mm.
  • Thread characteristics (for this model): thread length approximately 160 mm, USP diameter 3-0.
  • Sterile, single-use device supplied with each PDO thread preloaded on its cannula.

Formulation

  • Absorbable PDO (polydioxanone) barbed lifting thread medical device.
  • Molded spiral 360° cogs along the thread for circumferential grip and repositioning of tissue.
  • Preloaded on a 19G W-shaped, 90 mm cannula to aid insertion into the subcutaneous plane.
  • Part of the Countourel CE 2292 range of PDO threads by Croma-Pharma.
  • Class III CE-marked medical device manufactured to comply with EU Medical Device Regulation (MDR) requirements.
  • Intended exclusively for professional use by appropriately trained healthcare practitioners.

Packaging

  • Box containing 16 sterile Countourel Barbed PDO threads.
  • Each thread individually blister-packed and preloaded on a 19G W-shaped 90 mm cannula.
  • Product reference: 39475; HS/customs code indicated as 90183900 on distributor listings.
  • Packaging designed to protect sterility and stability, with each unit intended for single use only.
  • Shelf life indicated by the manufacturer/distributor as 2 years under recommended storage conditions.

Usage

  • For professional use only: implantation must be performed exclusively by qualified, specifically trained healthcare professionals experienced in PDO thread techniques and familiar with Croma Countourel guidance.
  • Use strict aseptic technique and follow the official Instructions for Use (IFU) supplied with the product for patient selection, anatomical planning, insertion vectors and post-treatment care.
  • Typically the preloaded 19G W-shaped cannula is introduced into the subcutaneous tissue or appropriate deep plane along pre-planned vectors in the mid and lower face, neck or other indicated regions, then the barbed thread is positioned to create tissue lifting and fixation.
  • Once satisfactory repositioning and tension are achieved, the cannula is withdrawn and any excess thread is trimmed at the entry point according to the IFU.
  • The number of threads and placement pattern should be tailored to the individual patient’s anatomy and aesthetic goals.
  • After treatment, patients are generally advised to avoid intense facial movements, strong mechanical pressure or massage in the treated area for a period defined by the practitioner, and to follow all aftercare instructions.
  • The device is single-use only; do not resterilise or reuse. Do not use if the sterile packaging is damaged or opened prior to use.

Contraindications

  • Use in patients who are pregnant or breastfeeding is generally not recommended unless a medical professional determines otherwise.
  • Known hypersensitivity or allergy to polydioxanone (PDO) or any component of the device.
  • Active infection, inflammation or skin disease at or near the intended treatment site.
  • Severe systemic illness, uncontrolled autoimmune disease, coagulation disorders or other conditions that in the opinion of the treating practitioner make thread lifting inappropriate.
  • Insertion through compromised, ulcerated or severely damaged skin at the treatment site.
  • Use in patients who are unable or unwilling to comply with post-treatment instructions, as determined by the treating practitioner.

Adverse Effects

  • Expected transient local reactions such as redness, swelling, bruising, tenderness or mild pain at insertion points and along the thread path.
  • Possible contour irregularities, dimpling, palpable or visible threads, asymmetry or dissatisfaction with the aesthetic outcome.
  • Potential for infection, inflammatory reactions, hematoma, or prolonged edema or pain at treated sites.
  • Rare but serious complications may include nerve or vessel injury, thread exposure, or significant inflammatory responses, requiring appropriate medical management.
  • All risks, side effects and potential complications should be discussed with the patient before treatment, and adverse events should be managed in line with clinical best practice and the manufacturer’s IFU.

Storage Conditions

  • Store in the original packaging to preserve sterility and protect the device from physical damage.
  • Keep in a clean, dry place away from direct sunlight, excessive heat and humidity.
  • Observe any temperature and storage conditions specified on the packaging and in the IFU.
  • Do not use the product after the expiry date indicated on the packaging.
  • Do not use if the sterile blister or outer packaging is opened, damaged or compromised before use.

Duration

PDO threads are gradually resorbed by the body over several months; while absorption time and longevity depend on thread type and patient factors, the mechanical lifting effect is immediate and the aesthetic benefits typically persist beyond the full resorption period as a result of collagen stimulation. The exact expected duration of effect should be discussed with the treating healthcare professional.

Onset

Immediate mechanical tightening and lifting following thread placement, with additional progressive improvement over time due to collagen stimulation in the treated tissues.

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