Estyme Fillers | Symatese

ESTYME FILLERS®

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WHY ESTYME® FILLERS?

ESTYME® FILLERS portfolio

It is the diversification of the formulas of each reference

ESTYME® FILLERS 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: C-HA.PURE TECHNOLOGY by SYMATESE™. A technology that makes it possible to develop highly targeted products, each dedicated to an indication of the face. Each product ESTYME® SMOOTH, LIPS, LIFT & SCULPT has specific characteristics and responds exactly and effectively to the needs of the area concerned.


INTENDED PURPOSE	Modification of the skin anatomy and facial appearance. (Non-medical purpose)
INDICATIONS	Indicated to correct nasolabial folds and perioral lines	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 labial mucosa	Dermis to hypodermis	Hypodermis and supraperiosteal

C-HA.Pure Technology by SYMATESE™

First generation cold technology

COLD 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 PURER, SAFER, LONGER LASTING and MORE NATURAL products.
Chains 4 times² more preserved in comparison with standard technologies

HIGH TEMPERATURE

TYPICAL CROSSLINKING

COLD TECHNOLOGY

COLD TECHNOLOGY by SYMATESE

All you need to know on ESTYME® FILLERS

Description

The gel of each ESTYME® FILLERS 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® FILLERS Product contains local anesthetic lidocaine in order to reduce pain and improve comfort during and post-injection.

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® FILLERS 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 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® FILLERS 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® LIPS is injected into dermis, hypodermis and labial mucosa
ESTYME® LIFT is injected into dermis to hypodermis

ESTYME®

SCULPT

Targeted population

Each ESTYME® FILLERS Product is used in adult subjects, excluding pregnant and breastfeeding women. Each ESTYME® FILLERS Product is not to be used in persons who are less than 18 years old.

Intended user

Each ESTYME® FILLERS 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® FILLERS Product is intended to be used in hospital environment or private medical offices.

What can you expect regarding performance and lifetime?

Each ESTYME® FILLERS 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. The maximum expected in-situ lifetime for Each ESTYME® FILLERS Product is 18 months. Each ESTYME® FILLERS Product contains local anesthetic lidocaine in order to reduce pain and improve comfort during and post-injection.


On average, with 1,2 mL injected in the nasolabial folds and 0.5 ml injected in lip fine lines, in one session, between 90 and 93% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)³.	On average, with 1 mL injected in the lips in one session, between 90 and 93% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)³.	On average, with 0.9 mL injected per nasolabial fold in one session, 82% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)⁵.	On average, with 1,1 mL injected per cheek in one session, between 58.2 and 60% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)⁴.

Additional information

Considering the composition of each ESTYME® FILLERS 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 V0.

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: a prospective, single center, comparative, double blinded clinical study evaluating the efficacy of a new dermal filler on nasolabial folds correction (CLIN 1701).

⁵ 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).

Informations for patients

The following document describes the regulatory content of the ESTYME® Patient Page in order to answer to the article 18 of the Regulation 2017/745 concerning the Implant Card and the information to be supplied to the patient with an implanted device.

Composition of the product range

Main ingredients


Total Sodium Hyaluronate	20 mg/g	20 mg/g	22 mg/g	23 mg/g
Lidocaine hydrochloride	3 mg/g	3 mg/g	3 mg/g	3 mg/g

References and units per box

DESCRIPTION	REFERENCE	Box composition
ESTYME® SMOOTH (Indicated to correct nasolabial folds and perioral lines)	SMOO1-300	1 blister / box including 1 injection device and 2 needles (2 x 30G½”) per blister.
	SMOO1-301	1 blister / box including 1 injection device and 2 needles (2 x 30G½”) per blister.
	SMOO2-300	2 blisters / box including 1 injection device and 2 needles (2 x 30G½”) per blister.
	SMOO2-301	2 blisters / box including 1 injection device and 2 needles (2 x 30G½”) per blister.

DESCRIPTION	REFERENCE	Box composition
ESTYME® LIPS (Indicated to correct the volume and the shape of the lips)	LIPS1-300	1 blister / box including 1 injection device and 2 needles (2 x 30G½”) per blister.
	LIPS1-301	1 blister / box including 1 injection device and 2 needles (2 x 30G½”) per blister.
	LIPS2-300	2 blisters / box including 1 injection device and 2 needles (2 x 30G½”) per blister.
	LIPS2-301	2 blisters / box including 1 injection device and 2 needles (2 x 30G½”) per blister.

DESCRIPTION	REFERENCE	Box composition
ESTYME® LIFT (Indicated to correct nasolabial folds)	LIFT1-300	1 blister / box including 1 injection device and 2 needles (1 x 30G½” and 1 x 27G½) per blister.
	LIFT1-301	1 blister / box including 1 injection device and 2 needles (1 x 30G½” and 1 x 27G½) per blister.
	LIFT2-300	2 blisters / box including 1 injection device and 2 needles (1 x 30G½” and 1 x 27G½) per blister.
	LIFT2-301	2 blisters / box including 1 injection device and 2 needles (1 x 30G½” and 1 x 27G½) per blister.

DESCRIPTION	REFERENCE	Box composition
ESTYME® SCULPT (Indicated to restore cheek volume loss)	SCUL1-300	1 blister / box including 1 injection device and 2 needles (2 x 27G½) per blister..
	SCUL1-301	1 blister / box including 1 injection device and 2 needles (2 x 27G½) per blister.
	SCUL2-300	2 blisters / box including 1 injection device and 2 needles (2 x 27G½) per blister.
	SCUL2-301	2 blisters / box including 1 injection device and 2 needles (2 x 27G½) per blister.

Products must be stored between +2°C and +25°C. Protect the gel from sunlight.

After opening, discard any unused material according to the institutional policies.

Get more information about ESTYME®

Manufacturers information

Legal Manufacturer of the injection device/ Procedure Pack Producer

SYMATESE SAS

ZI Les Troques

69630 Chaponost

France

Tel.: +33 (0) 4 78 56 72 80

Fax: +33 (0) 4 78 56 00 48

Legal Manufacturer of the needles:

TSK LABORATORY, JAPAN,

1510-1 Soja-Machi, Tochigi-shi,

Tochigi-ken, 328-0002 – Japan

EC Representative:

EMERGO EUROPE

Prinsessegracht 20

2514 AP The Hague

The Netherlands