WHY ESTYME®?
ESTYME® portfolio
It is the diversification of the formulas of each reference
ESTYME® products are unique integrated solutions [gel + delivery system] on the market, jointly developed by SYMATESE research. At the heart of the products, a proprietary technology created by our researchers and resulting from our expertise in hyaluronic acid: COLD-X TECHNOLOGY by SYMATESE®. A technology that makes it possible to develop highly targeted products, each dedicated to an indication of the face. Each products ESTYME® SMOOTH, LIPS, FORM, SCULPT & EYE has specific characteristics and responds exactly and effectively to the needs of the area concerned.
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INTENDED PURPOSE
| Modification of the skin anatomy and facial appearance. (Non-medical purpose)
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INDICATIONS | Indicated to correct nasolabial folds and perioral lines | Indicated to correct infraorbital hollows | Indicated to correct the volume and the shape of the lips | Indicated to correct nasolabial folds | Indicated to restore cheek volume loss
| |
TISSUES LEVEL OF INJECTION | Dermis to hypodermis | Dermis, hypodermis and supraperiosteal | Dermis, hypodermis and labial mucosa | Dermis to hypodermis
| Hypodermis and supraperiosteal | |
COLD-X TECHNOLOGY by SYMATESE®
First generation cold technology
COLD-X TECHNOLOGY by SYMATESE® based on the following key elements:
- An exclusive COLD temperature cross-linking process that induces less HA transformation1
- As little chemistry as possible for SAFE and LASTING products with natural effects.
- Chains 4 times2 more preserved in comparison with standard technologies
HIGH TEMPERATURE
TYPICAL CROSSLINKING
COLD TECHNOLOGY
COLD-X TECHNOLOGY by SYMATESE®
All you need to know on ESTYME®
Description
The gel of each ESTYME® Product is sterile, bioabsorbable, colorless made of crosslinked hyaluronic acid, non-crosslinked hyaluronic acid from non-animal sources and containing lidocaine hydrochloride 3 mg/mL.
Each ESTYME® Product contains local anesthetic lidocaine in order to reduce pain during and post-injection procedure.
The gel is supplied in a 1 mL plastic syringe which is the sterile barrier system. The gel is sterilized by moist heat (air/steam mixture). The syringe containing the sterile gel is assembled with plunger rod and finger rest and corresponds to the injection device. The needles supplied are sterilized by radiation.
Each ESTYME® Product is available in boxes of one or two protective blister(s) including an injection device and two ultra-thin wall needles.The injection device and the needles are for single use only.
Intended purpose
ESTYME® dermal fillers are intended for non-medical use only.
ESTYME® dermal fillers are intended to modify the skin anatomy and facial appearance.
Indications
 |  |  |  |  |
|---|---|---|---|---|
Indicated to correct nasolabial folds and perioral lines.
Injected into dermis to hypodermis. | Indicated to correct infraorbital hollows
Injected into dermis to hypodermis and supraperiosteal |
Indicated to correct the volume and the shape of the lips.
Injected into dermis, hypodermis and labial mucosa.
|
Indicated to correct nasolabial folds.
Injected into dermis to hypodermis. |
Indicated to restore cheek volume loss.
Injected into hypodermis and supraperiosteal |
 |  |  |  |  |
Contraindications
Each ESTYME® Product is contraindicated in:
- Minors.
- Subjects with a known allergy to hyaluronic acid, lidocaine or amide local anesthetics.
- Subjects with porphyria.
- Subjects with an autoimmune disorder, or using an immunosuppressant medication.
- Pregnant or breastfeeding women.
- Subjects with inflammation, infection or cutaneous disorders at the treatment site or nearby.
- Subjects with bleeding disorders or in subjects receiving thrombolytic or anticoagulant treatment
- Areas other than those recommended
- ESTYME® SMOOTH is injected into dermis, hypodermis
- ESTYME® EYE is injected into dermis, hypodermis and supraperiosteal
- ESTYME® LIPS is injected into dermis, hypodermis and labial mucosa
- ESTYME® FORM is injected into dermis to hypodermis
- ESTYME® SCULPT is injected into hypodermis and supraperiosteal
Targeted population
Each ESTYME® Product is used in adult subjects, excluding pregnant and breastfeeding women. Each ESTYME Product is not to be used in persons who are less than 18 years old.
Intended user
Each ESTYME® Product shall only be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law in injection techniques for the modification of facial anatomy.
Environment of use
Each ESTYME® Product is intended to be used in hospital environment or private medical offices.
What can you expect regarding performance and lifetime?
Each ESTYME® Product acts by adding volume to the tissue, thereby restoring the skin contours and the volume and shape of the face to the desired level. The volume and lifting capacity originate from the ability of the crosslinked hyaluronic acid gel to hold its shape in the tissue, thus maintaining over time the volume and projection obtained at injection. The duration of effect depends on the area treated and the depth of injection, and may vary from one subject to another.
Each ESTYME® Product contains local anesthetic lidocaine in order to reduce pain during and post-injection procedure.
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On average, with 1,2 mL injected into the nasolabial folds and 0.5 ml injected into lip fine lines, in one session, 81.9% of subjects are noticeably improved at 12 months (clinical study results obtained with the Global Aesthetic Improvement Scale)3,7.
The expected lifetime for ESTYME ® SMOOTH is 12 months. | On average, with 0.5 mL injected per infraorbital hollow in one session, between 68.4 and 71.9% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)4.
The expected lifetime for ESTYME ® EYE is 12 months. | On average, with 1 mL injected into the lips in one session, 93% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)3.
The expected lifetime for ESTYTME ® LIPS is 12 months | On average, with 1.2 mL injected per nasolabial fold (including optional touch-up), 73.8% of subjects are noticeably improved at 12 months (clinical study results obtained with the Global Aesthetic Improvement Scale)5,7.
The expected lifetime for ESTYME® FORM is 12 months | On average, with 1.9 mL injected per cheek (including optional touch-up), between 62.8% of subjects are noticeably improved at 18 months (clinical study results obtained with the Global Aesthetic Improvement Scale)6,8.
The expected lifetime for ESTYME® SCULPT is 18 months. |
Additional information
Considering the composition of each ESTYME® Product, there is no warning, precaution and/or measure to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures. The supplied needles must not be used under MRI.
1 FASY MDR 23-031 V2.
2 FASY 19-036 V0.
3 Internal data: prospective study evaluating lips enhancement and perioral lines correction with FASY hyaluronic acid dermal fillers (CLIN 1901).
4 Internal data: an interventional prospective study evaluating the safety and performance of FASY hyaluronic acid dermal filler in correction of infraorbital hollows (CLIN 1902).
5 Internal data: a prospective, single center, comparative, double blinded clinical study evaluating the efficacy of a new dermal filler on nasolabial folds correction (CLIN 1701).
6 Internal data: an interventional prospective study evaluating the safety and performance of FASY hyaluronic acid dermal filler in correction of cheeks volume loss (CLIN 1907).
7 Internal data: Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of Precise Dermal Fillers in the Treatment of Nasolabial Folds. (CLIN2101)
8 Internal data: Prospective, Multi-Center, Randomized, Controlled, Blinded Study of the Safety and Effectiveness of Precise Sculpt Dermal Filler to Correct Age-Related Volume Deficit in the Mid-Face (CLIN2102).
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