MEDICAL EQUIPMENT

PDO THREAD NEEDLE
Dermal filler

PDO THREAD NEEDLE

Beautiful change!
Be born again! Yourface and body!
Elastin Plus Line
Fast and Safe Natural Treatment
Thread Lifting

25G 26G 27G 28G 29G 30G	Needle length	Thread length
	25mm	30mm
	38mm	60mm
	50mm	80mm
	60mm	100mm
	90mm	160mm

Thread Lifting Prime Mono

"Prime mono"
1 st Generation Mono Lift

Generally, Mono lift called " Prime-Mono" is to embed PDQ into the skin It is largely effective in facial lifting and wrinkle improvement through self stimulation of cells. There is no interruption in a daliy life even right after the procedure. In addition.There is no side effect or worries about removal operation because it will be fully dissolved in the body after 1-2 year. This is biodegradable, biocompatible, safe and dissolves within the body.

25G 26G 27G	Needle length	Thread length
	38mm	60mm
	50mm	80mm
	60mm	100mm
	70mm	120mm
	90mm	160mm

Thread Lifting PrimeTwin

Twisted Thread
Better! Stronger! More Powerful!

"Prime-Twin" is more advanced stage than mono lift (Single Fiber) It is designed as twisted pairs of the mono lift thread that accelerates stronger stimulation into SMAS layer and ends up forming more collagen. Twisted PDO is thicker and stronger than single fiber so the effect for lifting skin is more powerful !

23G 25G 26G	Needle length	Thread length
	38mm	60mm
	50mm	80mm
	60mm	100mm
	70mm	120mm
	90mm	160mm

Thread Lifting Prime Screw (Double Scerw)

Generally, Mono lift called " Prime-Mono" is to embed PDQ into the skin It is largely effective in facial lifting and wrinkle improvement through self stimulation of cells. There is no interruption in a daliy life even right after the procedure. In addition.There is no side effect or worries about removal operation because it will be fully dissolved in the body after 1-2 year. This is biodegradable, biocompatible, safe and dissolves within the body.

"Prime Screw"

Double Screw with 2 strands of screw shaped sutures can hold skin more tightly and stimulate collagen twice more than normal Screw type. dissolves within the body.

25G 26G 27G 28G 29G 30G	Needle length	Thread length
	38mm	60mm
	50mm	80mm
	60mm	100mm
	70mm	120mm
	90mm	160mm

Fast and Safe Natural Treatment Thread Lifting

"Prime Screw"Product inserted the suture thread into needle at constant rate, rolled and knotted it into screw shape and fixed it by a sponge depending on the length of needle tube.

19G 21G 23G 25G	Needle length	Thread length
	38mm	60mm
	50mm	80mm
	60mm	100mm
	90mm	150mm
	100mm	150mm

Thread Lifting Prime Cog
(Single Cog/Double Cog} (Cog1R/Cog2R/Multi Cog/3D Cog}

3rd Generation "Prime Cog"is barbed embedding thread whcih has Cogs and barbs on it. As point of contact to tow panniculus carnosus is in creased, lifting effect is maximized. Polydioxanone suture and ligature thread on which has cogs and barbs through its manufacturing process

PRIME PDO THREAD NEEDLE DIAGRAM - Q&A

Forhead
(29G, 31 G)
38mm/ 50mm

V-Line
(29G, 31 G)
38mm, 50mm

Neck
(29G, 31G)
38mm, 50mm

Nose
(29G, 31G) 90mm
(29G) 30mm

Dress Line
(25G, 27G)
50mm/ 90mm

T-Line
(25G) 90mm

Hip-up
(25G, 27G)
60mm/ 90mm/ 150mm

Calf-muscle
(25G, 27G)
90mm/ 150mm

Q & A

Q: How long does the procedure takes?
A: Depending on treatment area, usually, it takes about 30 minutes.
Q: How about the pain?
A: Use the lidocaine cream before the procedure, youfeeljust slight pain in some areas only!
Q: How long is the effect lasting?
A: Show immediate lifting and up to 6-12 month.
Q: When can feel the effects?
A: Right after the procedure can see the effect already.
Q: Are there any side effects?
A: Usually, there is no serious side effects due to using safety absorbable material, The only complications are small bruises.
Q: Are there any problem in daily life?
A: 1-2 days ofsweling and pinpoint bruises so usually no problem with daily activity.
Q: Which areas can be improved?
A: Face, Neck, Specific wrincles, Breast, Calfmuscle, Hip-up, Alopecia. etc ..

Before & after

Vector Linear technique of the skin of lips before and after 1 month

Vector technique for folds before and immediately after

Mesh technique for folds before and immediately after

Combination technique of the skin before and after 1 month

Vector Linear technique of the skin of lips before and after 14 days

specification for prime pdo thread

Model Name	Needle size	Needle Length	PDO length
Mono	25g	38	60
		50	80
		60	100
		90	160
	26G	38	60
		50	80
		60	100
		90	160
	27G	38	60
		50	80
		60	100
		90	160
	29G	25	30
		38	60
		50	80
		60	100
	30G	25	30
	30G	38	60
Twin	25G	38	60
		50	80
		60	100
		70	120
		90	160
	26G	38	60
		50	80
		60	100
		90	160
Single Screw	25G	60	100
	26G	38	60
		50	80
		60	100
		90	160
	27G	38	60
		50	80
		60	100
	29G	38	60
		50	80
		60	100
	30G	38	60

Model Name	Needle size	Needle Length	PDO length
Double Screw	23G	70	120
	25G	38	60
		50	80
		60	100
	26G	38	60
		50	80
		60	100
		70	120
		90	160
		100	180
Single Cog	19G	100	150
	21G	90	150
	23G	38	50
		50	70
		60	100
		60	110
		90	140
		90	150
	25G	90	130
	25G	90	150
Double Cog	19G	100	150
	21G	90	150
	23G	38	50
		50	70
		60	100
		60	110
		90	130
		90	140
		90	150
Cog 1R	19G	100	150
	21G	90	150
	23G	90	150
Cog 2R	19G	100	150
	21G	90	150
	23G	90	150
3D Cog	19G	100	150
	21G	90	150
	23G	90	150

Hyafilia

What is Hyafilia?

HyaFilia is used for tempoaray improvement of wrinkles by injecting ut into the skin layer around the facial wrinkles. it is a colorless and transparent gel-type product width viscoelasticity composed of a stabilized non-animal hyauronic acid.

HyaFilia is tissue reconstructive material that intended to be used for facial tissue augmentation. It is recommended that the product be used for the correction of moderate to severe facial wrinkles, folds, and acne scars.

Characteristics of HyaFilia

medical divice

CE Mark approval (Feb, 2012) · ClassⅢ
KFDA approval (May, 2013)
· Graft/prosthesis, biomaterial · B04230.01(4)

Non-animal hyaluronic acid

Usage of HA produced by bacterial fermentation (Streptococcus equi)
Biocompatibility · Non-toxic · Non-immunogenic
Biodegradability

BDDE Crosslinked HA

BDDE cross-linked HA
· To overcome the short biodegradability of natural HA
· Improvement of the sustainability

Gel type

HA Conc. : 20mg/ml (2%)
High viscosity gel : 2,700,000 cP
Injection Force : 10 N

Proven safety and efficacy

Through multicenter clinical trial, safety and efficacy of HyaFilia have been proven.

Comparison between HA fillers

Classification	HyaFilia	R-product	J-product
Composition	hyaluronic acid	hyaluronic acid	hyaluronic acid
Crosslinking agent	BDDE	BDDE	BDDE
Total HA concentration (g/ml)	20	20	22~26
Complex viscosity (cP)	2.7 x 10⁶	2.8 x 10⁶	0.9 x 10⁶
Swelling ratio (ml/g)	4	2.8	3.8
Injection force (N)	10	9	13
Endotoxin (EU/ml)	Less than 0.25	Less than 0.5	-

* HyaFilia has similar chemical and physical features with R-product and J-product which are currently dominating the filler market.

Efficacy Test

From the internal duration test using mouse, HyaFilia had longer durability than J-product and similar durability with R-product. From the histological test, HyaFilia showed superior result within the material remaining for 4months and connective tissues. Plastic surgery division of Korea University Medical college (April, 2010)

Character

The following biocompatibility and toxicology tests were conducted on HyaFilia.

Residual BDDE is not detected in HyaFilia

Animal Studies Safety

The following biocompatibility and toxicology tests were conducted on HyaFilia.

Test Title	Test Number	Test Standards	Test Results
Acute Systemic Toxicity Test	SNUH 0800401	ISO 10993-11	Pass
Subchronic Subcutaneous Toxicity and Implantation Test in Rat - 13 Weeks	SNUH 0800402	ISO 10993-11 ISO 10993-6	Pass
Cytotoxicity Test	SNUH 0800403	ISO 10993-5	Pass
The Guinea Pig Maximization Test	SNUH 0800404	ISO 10993-10	Pass
Hemolysis Test	SNUH 0800405	ISO 10993-4	Pass
Intracutaneous Reactivity Test	SNUH 0800406	ISO 10993-10	Pass
Pyrogen Test	SNUH 0800407	USP 29	Pass
Bacterial Reverse Mutation Assay	SNUH 0800408	ISO 10993-3	Pass
In vitro Chromosome Aberration Test	SNUH 0800409	ISO 10993-3	Pass
In vivo Micronucleus Test	SNUH 0800410	ISO 10993-3	Pass

Testing Period ~ February 2009
Testing Institution Medical Device Evaluation Center, Clinical Research Institute, Seoul National University Hospital, Korea

Efficacy Evaluation

Primary Efficacy Evaluation / HyaFilia is non-inferior compared to R-product
HyaFilia is non-inferior compared to R-product WSRS average difference between R-product applied area and HyaFilia applied area was -0.03±0.75 .The lowest value of single one-sided 97.5% confidence interval regarding WSRS result was -0.22.As this was bigger value than -0.29 which was the non-inferiority limit in this trial, HyaFilia's non-inferiority was proved.

Secondary Efficacy Evaluation / Patient's Satisfaction Level
Patient's Satisfaction Level : Among GAI average value evaluated by subject on the 8th, 16th, and 24th week, HyaFilia's satisfaction level was higher than R-product on the 8th and 24th week. However, it is not statistically significant.

Conclusion

HyaFilia used to improve nasolabial fold is considered as an effective and safe medical device.

HyaFilia Series Information

Manufacturing process

	HyaFilia Petit™	HyaFilia®	HyaFilia Grand™
HyaFilia
Composition	Cross-linked hyaluronic acid (20mg/ml)	Cross-linked hyaluronic acid (20mg/ml)	Cross-linked hyaluronic acid (20mg/ml)
Average grain size	200㎛	500㎛	1,100㎛
Indications	Correction of superficial wrinkles: fine lines and wrinkles on thin skin	Filling of all moderately pronounced wrinkles on the full face	Filling wrinkles
Injection area	Superficial dermis	Mid dermis	Deep dermis or subcutaneous tissue
Packaging units	·HyaFilia Petit 1.0: 1ml (27G, 29G)	·HyaFilia Petit 1.0: 1ml (27G, 29G)	·HyaFilia Petit 1.0: 1ml (27G, 29G)
Storage conditions	To be stored at room temperature (1-30℃) away from direct sunlight.
Shelf life	36 months

MURACO Contact Us

For more discussion and details, Please contact us.
Intl. Cell/Text: +1 236-302-2121 / +81-(03)-3814-8387
Tel/Text: +44 7784908375
Fax : +81 (03) 3816 7839
E-mail : info@muracomedical.com
Contact Person: Andrew Cooper
Email: andrew.cooper@muracomedical.com
Homepage : www.muracomedical.com
Address : Dojima, 1 Chome-2-21, Kita-ku, Osaka 530-0003, Japan

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