What is Intella®?

Intella® is a dermal filler that is injected for facial soft tissue augmentation. It contains 55.7% calcium hydroxyapatite microspheres suspended in 20 mg/ml cross-linked sodium hyaluronate gel of non-animal origin. The lidocaine in this product also helps reduce pain during injection.

How is the mechanism of action of Intella®?

Intella® provides an immediate volumizing effect through hyaluronic acid. Additionally, the calcium hydroxyapatite microspheres form a scaffolding structure that stimulates fibroblasts to produce new collagen.

What are the indications of Intella®?

Intella® provides an immediate volumizing effect through hyaluronic acid. Additionally, the calcium hydroxyapatite microspheres form a scaffolding structure that stimulates fibroblasts to produce new collagen.

Ingredients

Each package contains two 1-ml sterile syringes, two 27G x 1.2″ sterile disposable needles, a manual, and a set of tracking labels (one for the patient and one for their file).

  • • Calcium hydroxyapatite microspheres with a diameter of 25–45 microns (55.7%)
  • • Cross-linked sodium hyaluronate gel (20 mg/ mL)
  • • Lidocaine hydrochloride (3 mg/mL)
  • • Phosphate buffer

What are the indications of Intella®?

Avoid using this product if you have hypersensitivity to the product components. Avoid using this product if you have an inflammation/irritation of the hair scalp, skin alteration, skin disease, infections or sequelae of streptococcal infections. Avoid using this product if you have an autoimmune disease history or if you are taking immunosuppressants or corticosteroids. Avoid using this product during pregnancy or breastfeeding. This product is not recommended for children or minors under 18 ages. If you are taking medication or have specific experience with particular drug reactions, consult your physician before the treatment.

How Intella® should be administered?

Different facial regions and severity of volume deficit affect the injection technique and volume of implant injected.

Insert the needle at an angle of 30° into the deep dermis. The bevel should be oriented downwards to minimize implant deposition into a more superficial plane. Palpate the region with your free hand to confirm insertion of the needle into the skin layer of interest. Superficial injection or deposition of large volumes of the implant may result in discoloration, nodules, or ischemia at the skin surface.
Inject the gel by applying mild continuous pressure on the plunger rod while slowly withdrawing the needle, thus forming a single uniform thread of injected gel inside the tissue (linear threading technique). When correcting deep folds, several threads should be layered in parallel lines beneath the fold. If larger volumes are required, such layers can be deposited on top of each other, the threads of each layer perpendicular to those in the underlying layer (cross hatching technique).
Substantial mechanical resistance to the injection of the implant may be resolved using the following measures: first, horizontally relocate the needle; second, inject from a different entry point; third, replace the needle or even the syringe.
Blanching may indicate injection into a superficial skin layer or into a blood vessel. In case of blanching, stop injecting and massage the area until color returns to normal.
If normal skin color does not return, the injection process should not be resumed. Vasodilatory or other measures should be considered.
Stop injection before pulling the needle out of the skin to avoid gel leakage into superficial skin layers.

Discard needle in appropriate biohazard waste bin.
Repeat the procedure if further correction is necessary, but only after thoroughly assessing the treated area and patient status.
After completing the injection, gently massage the treated area to ensure even distribution of the gel and to mold the gel to the tissue contour.

What are the advantages of Intella®?

  • A stable inseparable gel
  • a strong volumizing and lifting effect (immediate and long-lasting effect)
  • promotes the generation of natural collagen
  • biocompatible and biodegradable
  • susceptible to hyaluronidase

How is the storage condition of Intella®?

  • Store between 2 to 25℃.
  • Store away from sunlight, heat, and freezing.

What is the important safety information about Intella®?

  • For single use only. Do not resterilize.
  • Only the fluid path and syringe contents are sterile.
  • To be used as supplied. Modification of the product may negatively impact its sterility and performance.
  • For use under sterile conditions only.
  • Must be used prior to the expiration date printed on the package.
  • Do not use if the package is open or has been tampered with.
  • Do not use if device damage (e.g., cracked or broken syringe barrel, open syringe cap, or plunger stopper) is suspected. Discard any damaged device. The medical practitioner must be familiar with the device and the implantation procedure and technique. In using the device, clinical judgment must be made regarding its application. In all cases, sound medical practice is to be followed by the user.
  • Use with caution in patients with a history of herpes or recent dental treatments or infection. Use with caution in patients currently on immunosuppressive therapy.
  • Use with caution when injecting in proximity to other implanted dermal fillers.
  • Use with caution when injecting into the marionette line and oral commissures. Do not overcorrect to prevent material migration into the lips.
  • Allow at least 4 weeks between ultrasound-based treatments, laser or peeling treatments, and use of this product.
  • Intella® injection may be accompanied by mild discomfort; administration of anesthetics should be considered.
  • As with all transcutaneous procedures, injection of Intella® carries a risk of infection. To reduce this risk, common practice of such procedures should be followed.
  • Intella® should not be used in patients under treatment with substances that can prolong bleeding (e.g., aspirin, anticoagulants, thrombolytics, anti-inflammatories, ACE inhibitors) as increased bruising and bleeding may occur.
  • Intella® must not be injected into tissues that may be harmed by the volumizing properties of dermal fillers.
  • Intella® must not be injected into or via scar, cartilage, compromised, infected, or inflamed tissues.
  • Do not over-inject. Over-injection may result in mechanical damage to the tissue.
  • Hyaluronic acid and quaternary ammonium salts (e.g., benzalkonium chloride) are incompatible. Contact must be avoided.