ELLANSE™ M

Product: ELLANSE™ M 2-1ml prefilled syringes
Active Compositions: PCL microspheres, gel carrier (Phosphate buffered saline, glycerin, carboxymethylcellulose.
Volume & Packaging: 2×1 ml syringes.
Manufacturer: AQTIS Medical BV.
Also Included: Contains 2×1 ml syringes, 4 27G x 3/4” needles, packaging insert.
Remarks: Steryl packaging.

Ellanse M is an absorbable soft tissue implant made of synthetic and latex-free polycaprolactone (PCL) microspheres. These microspheres are suspended in a carrier gel containing carboxymethylcellulose (CMC), glycerin and phosphate buffered saline solution, and have a particle size of 25 to 50 microns. This allows them to instantly add volume to wrinkles, while also boosting the skin’s collagen production.

Each package of Ellanse M comes with 2-1mL syringes, 4-27G¾” sterilized needles, and a product manual. Its packaging is sterile and must be stored at temperature between 15 and 25°C and protected from both sunlight and freezing conditions.

Ellanse M is manufactured by AQTIS Medical BV, a subdivision of London-based Sinclair Pharma.

Ellanse M is made with synthetic PCL, a well-known bioresorbable medical polymer. In this filler, PCL helps to restore durable elasticity by stimulating collagen production, while the carrier gel delivers immediate volume to facial creases. Some areas that respond well to this aesthetic filler are the cheeks, temples, and jawline. Major wrinkles, including nasolabial folds and marionette lines, may also be corrected with Ellanse M. Additionally, facial structure augmentation on the nose and chin may also be done with this injectable solution.

Skin ageing is marked by the formation of wrinkles and lines on the most mobile areas of the face. This occurs when existing fundamental cells, including hyaluronic acid and collagen, reduce in quantity and quality. With this, wrinkles and dry, flaky skin emerge on the face. Also, some patients experience ageing through unintended subcutaneous weight loss or fat redistribution, causing fleshy areas like the cheeks and temples to become sunken and gaunt. Skin issues are worsened when free radicals from external sources, like pollution and chronic sunlight exposure, harm the already weakened skin structure.

Ellanse M is formulated with the microspheres of a commonly used medical polymer, known as PCL. The U.S. Food & Drug Administration (FDA) has approved this biodegradable material for use in the human body due to its excellent safety profile.

This filler is processed with both Tunable Longevity Technology, which allows the gel to provide its aesthetic benefits for up to 2 years. After administration, the gel carrier provides instant volumizing effects, while PCL microspheres utilize the body’s response to foreign bodies to induce collagen formation. As a result, skin depressions are easily filled in and lifted for longer periods of time.

Ellanse M injections are medical procedures, and as such, may only be conducted by approved medical practitioners who specialize in aesthetic treatments. Since these are medical procedures, they must also be conducted aseptically.

To begin, disinfect the targeted areas thoroughly and assemble the medical device by securing a suitably sized needle to the prefilled syringe. Place the needle at a 30-degree angle to the skin and inject the implant into the deep dermis or subcutaneous layer slowly. Gently massage the treated areas to ensure good gel integration with the facial contours.

For the best possible treatment outcome, please adhere to the following precautions during injection:

1. Do not overcorrect any area;
2. Do not use the implant to correct superficial wrinkles or for lip augmentation;
3. Do not inject the gel into blood vessels;
4. Do not resterilise the gel for a second-time use. Each preloaded syringe is only intended for single use.

After this process is complete, discard any leftover gel and used needles as well as syringes—if done improperly, this could pose a potential biological hazard. As part of aftercare, inform patients to refrain from applying makeup for a minimum of 12 hours after injection. They should also avoid direct sunlight for a week following treatment.

Refer to the product manual for a complete list of precautions.

Ellanse M is formulated to undergo controlled bioresorption, resulting in sustained implant performance. This particular dermal filler has been shown to last for up to 2 years, after which it is slowly dissolved into the surrounding tissues.

This dermal filler is a safe and clinically proven synthetic cosmetic treatment, composed of completely smooth PCL microspheres which are homogeneously suspended in an aqueous gel carrier. This treatment has been tested rigorously by both its producer and outside organizations, cementing its safety and effectiveness. However some contraindications do exist for Ellanse M, including the following:

1. Hypersensitivity to any of the constituents in this filler;
2. Dermal disorders on targeted areas (e.g. hypertrophic scarring, keloids, acne, hives, cold sores);
3. Permanent implants or other aesthetic treatments done on proposed treatment areas;
4. Pregnancy or breastfeeding;
5. Being under the age of 18.

Refer to the product manual for a complete list of contraindications.

After injection with Ellanse M, Some mild side effects may occur. However, these usually resolve themselves up to one week after the procedure.

• Swelling
• Redness
• Tenderness
• Itching
• Discolouration

Some patients have reported some adverse reactions to Ellanse M, although these are rare.

• Severe allergic reaction
• Vision abnormalities
• Migration of filler material
• Formation of permanent nodules
• Stroke

If the patient experiences any severe reactions, they must seek prompt medical attention.

Ellanse M is a safe, effective, and clinically proven synthetic skin treatment, composed of smooth PCL microspheres, which are homogeneously suspended in an aqueous gel carrier. This dermal treatment offers the maximum potential for remodelling and correcting facial features due to its excellent combination of viscosity, uniform homogeneity, and unique elasticity.