the ultimate generation of suspension...

The Ultimate Generation of

Suspension Thread

For Aesthetic Medicine and

Cosmetic Surgery

Company

Aging & Lifting

Spring Thread® main characteristics

Implantation Methods and Recommendations

Clinical results

SUMMARY

French Company established in May 2007

Funder : Jean Frismand Medical doctor

Biomechanical engineer

More than 25 years experience in designing and

Manufacturing surgical implants

Owner & C.E.O. : Dominique Malard Business School (1989) + E-MBA (2010)

In biotech industry since 2006

Management + Business Development

COMPANY

Tourcoing nearby Lille

Between Brussels, Paris and

London

Known for textile, mining and

biotech industry.

LOCATION

Production :

100% Made in France (2 manufacturing plants)

Strong commitment for Quality

ISO 13485

CE Marked (Medical Device class IIb)

To Date :

More than 70.000 threads in place

Representations : 40 Countries Asia : Japan, Thailand, Indonesia, Malaysia, Vietnam, China,….

Europe : France, Benelux, Italy, Spain, Portugal, Russia, UK…..

Maghreb : Morocco, Algeria, Tunisia….

Middle East : Dubai, Qatar, Egypt, Saudi Arabia, Kuwait

Latin America : Colombia, Argentina, Chile, Venezuela, Mexico,

PRODUCTION

Four fundamental values

of the company

But moreover, we want that our doctors and patients have a

GOOD Spring Thread® EXPERIENCE

Good product

and Services

Good

Experience Happy Patients

Aging ? Facial Aging ?

Tissue Alteration :

Fillers

Cutaneous Modification : Peeling

Tissue Loosening :

Lifting

Other rejuvenation methods :

Botox, Lasers, Co2, Leds…

Facial Aging !

*Valeant Aesthetics

35 years 45 years 55 years

The aging process changes the main structures of the face,

including skin, fat, muscles and bone structure.

Aging has to be considered

as GLOBAL Phenomenon Answer Solutions

Skin structure modification Skin caring

Cosmetics, skin boosters,

Mesotherapy,

Peelings,

Lasers…

Loss of volume Filling Injectable,

Fat grafting

Ptosis Lifting Surgical Lifting

Thread Lifting

35 years 45 years 55 years *Valeant Aesthetics

What about Ptosis ?

Lifting

Surgical

Lifting

Thread

Lifting

Absorbable Threads

Biochemical

Stimulation

Permanent Threads

Mechanical

Suspension

Surgical lifting : lift the tissues + remove cutaneous excess Surgery

Recovery time

Non reversible

More horizontal action

Thread lifting : non invasive lift For moderate ptosis

No skin devascularisation

Very few social eviction : 2 to 3 days

More Vertical traction

Ptosis :

Surgical or Thread Lifting ?

Vertical traction

Natural support of adipose tissues without modification of the face features

Special thanks to Dr Denis Guillo and the SOMEREFs

No General anaesthesia,

No scars,

No contraindication (i.e. smokers),

Limited infectious risk,

Secured gesture : the threads are in the sub-cutaneous territory without getting over the SMAS,

Answer to younger patients who are refusing or who are refused by surgery,

Vertical traction : natural support of adipose tissues without modification of the face features,

Efficient on the three parts of the face, if well applied,

Less expensive.

Advantages of Thread Lift

How to choose?

Absorbable Threads : Biochemical Stimulation

Adapted to young patients

Rejuvenation effect (6 to 12 months maximum)

Limited risk in case of bad implantation…..

Non Absorbable Threads : Mechanical Suspension Adapted to all patients

Real Suspension and Reorganisation of the tissues for a long term effect (3 to 5 years minimum)

More technical possibilities

Permanent : Suspension

Absorbable : Rejuvenation

Between Biochemical stimulation or Mechanical Suspension,

the doctor will choose the best strategy according to the profile

and to the expectations of his patient.

Do not confuse stimulation

and suspension

PRODUCTS ON THE MARKET

APTOS®

Non elastic monofilament of polypropylene

5 Aggressive cogs per cm

Inconstant result, extrusion risk

Deadpan aspect, figé, definitive positioning at starting

Painful surtension

SILHOUETTE LIFT®

Non elastic monofilament of polypropylene with nots

Polylactic Acid resorbable cone

Absorption of cones after 8 to 12 months

Result : about 2 years

Needs anchorage points

Korean Threads / Chinese Threads

Aptos Light Lift / Silhouette Soft

Absorbable (PDO or PLLA)

Non elastic

Fragile

Small cogs or no cogs

3 month to 6 months result

NOT SUSPENSION THREADS BUT REJUVENATION THREADS !

RESORBABLE THREADS CAN NOT BE EFFICIENT FOR

REAL PTOSIS CORRECTION

SPRING THREAD ® Body

SPRING THREAD ® Face

SILHOUETTE LIFT ®

UPACTIV ®

HAPPYLIFT ® résorbable

APTOS ®

Fil lisse

Copyright SOMEREFs

PRODUCTS ON THE MARKET

Spring Thread® answers optimally to market expectations

A NEW ERA IN

SUSPENSION THREADS

PATIENTS REQUESTS :

Security

Long Term Action

PRACTITIONNERS NEEDS :

Reliability

Simplicity

Spring Thread ANSWERS :

Elasticity – Flexibility

Strength

Excellent fixation

Permanent Thread

Moulded and non

aggressive cogs

Polyester Core

Silicone

4 MAJOR INNOVATIONS

Flexibility and elasticity

Solidity and controlled

elasticity

Excellent Fixation in the

tissues

Long Term Action

flexible, elastic, 24 convergent 3D cogs/cm

flexible, elastic, 24 convergent 3D cogs/cm

SPRING

THREAD®

Spring Thread® Silicone

The better accepted material by the body

100% Biocompatible and Biostable

No Inflammatory reaction

No extrusion or migration

Good fibrosis

Parameters

Conducted Tests

Conclusion

Standards Standards Title Name and

Reference Test

Cytotoxicity ISO 10993-5 : 2009 Biological Evaluation of Medical Devices –

Part 5: Tests for In Vitro Cytotoxicity

L929 MTT Cytotoxicity Test*

(TOXIKON 10-2121-G1)

Non-cytotoxic

Sensitization ISO 10993-10 : 2002

Amended 2006

Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Delayed –

Type Hypersensitivity

Kligman Maximization Test*

(TOXIKON 10-2121-G3) Non-irritant

Irritation and intracutaneous

reactivity

ISO 10993-10 : 2002

Amended 2006

Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Delayed –

Type Hypersensitivity

Intracutaneous Injection Test*

(TOXIKON 10-2121-G2) Non-irritant

Acute systematic

Toxicity

ISO 10993-11 : 2006 Biological Evaluation of Medical Devices –

Part 6: Tests for Systemic Toxicity

Systemic Injection Test*

(TOXIKON 10-2121-G4) Non-toxic

Subchronic Toxicity

ISO 10993-6 : 2007

Biological Evaluation of Medical Devices – Part 6: Tests for Local Effects After

Implantation

Subcutaneous Implantation Test*

(13 weeks)

(TOXIKON 10-2121-G10)

Non-irritant ASTM F981-04

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical

Implants with Respect to Effect of Materials on Muscle and Bone

ASTM F763-04 Standard Practice for Short Term Screening

of Implant

BIOCOMPATIBILITY Tests realized with a certified laboratory on finished product

Parameters

Conducted Tests

Conclusion

Standards Standards Title Name and Reference

Test

Genotoxicity

Carcinogenicity

Reproductive Toxicity

ISO 10993-3 : 2003

Biological Evaluation of Medical Devices – Part 3: Tests for Genotoxicity, Carcinogenicity and


Chromosomal Aberration Assay*


Non-clastogenic

OECD 473 (21 July 1997)

Guidelines for the Testing of Chemicals, “In vitro Mammalian Chromosomal Aberration Test”

ISO 10993-3 : 2003

Biological Evaluation of Medical Devices – Part 3: Tests for Genotoxicity, Carcinogenicity and


Salmonella Typhimurium and

Escherichia Coli Reverse Mutation

Assay*


Non-mutagenic

OECD 471 (21 July 1997)

Guidelines for the Testing of Chemicals, “Bacterial Reverse Mutation Test” (Ames Test)

Implantation

ISO 10993-6 : 2007 Biological Evaluation of Medical Devices – Part

6: Tests for Local Effects After Implantation

Subcutaneous Implantation Test*

(2 weeks)


Non-irritant ASTM F981-04

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical

Implants with Respect to Effect of Materials on Muscle and Bone

ASTM F763-04 Standard Practice for Short Term Screening of

Implant

Hemocompatibility ISO 10993-4 : 2002

Amended 2006

Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood

Hemolysis Human Blood

Indirect Contact*


Non-hemolytic

Pyrogenicity**

ISO 10993-11 : 2006 Biological Evaluation of Medical Devices – Part

6: Tests for Systemic Toxicity Rabbit Pyrogen Test*


Non-pyrogenic

USP 32

Formula 27 :2009 <151> Pyrogen Test Non-pyrogenic

Components Security Tests

Conclusion

Standards Name / Supplier

Bioburden ISO 11737-1 : 2006

Sterilization of medical devices – Microbiological methods : Determination of a population of

microorganisms on products

Conform

Sterilization

ISO 11135-1 : 2007

Sterilization of health care products – Ethylene oxide : Requirements for development, validation and routine

control of sterilization process for medical devices

Conform

ISO 11135-2 : 2008 Sterilization of health care products – Ethylene oxide :

Directive on the application of ISO 11135-1 Conform

ISO 11138-1 : 2006 Sterilization of health care products – Biological

indicators : General requirements Conform

ISO 11138-2 : 2006

Sterilization of health care products – Biological indicators : Biological indicators for ethylene oxide

sterilization

Conform

ISO 10993-7 : 2009 Biological evaluation of medical devices : Ethylene oxide

sterilization residuals Conform

Residual ethylene oxide,

ethylene chlorhydrin and ethylene glycol

ISO 10993-7 : 2008 Biological evaluation of medical devices : Ethylene oxide

sterilization residuals Conform

ISO 11135-1 : 2007

Sterilization of health care products – Ethylene oxide : Requirements for development, validation and routine

control of sterilization process for medical devices

Conform

ISO 11135-2 : 2008 Sterilization of health care products – Ethylene oxide :

Directive on the application of ISO 11135-1 Conform

STERILITY Tests realized with a certified laboratory on finished product

Sterilization realized by a certified sterilizer subcontractor

IMPLANTATION TECHNIQUES

From 35 to 75 years old,

Good psychism,

No important general disease,

Small or medium ptosis,

People : • too young for surgical lifting,

• who don’t need surgical lifting,

• who don’t want surgical lifting,

PATIENT SELECTION

Face oval

Nasolabial folds

Marionette Lines

Cheeks

Eyebrows

GOOD INDICATION

Too important sagging

Too much fat

Too much skin

Elastosis wrinkles or heliodermic skin

BAD INDICATION

STRONG ASEPTIA IS

FUNDAMENTAL

Soft needle : no risk to touch

nerves or vessels

The thread has to be placed in

the subcutaneous fat, before the

SMAS (between 2 and 3 mm

deep), but not too superficial not

to touch any hair follicle

(Especially in the hair area)

Implantation : Subcutaneous Fat

No Anatomical Risk !

The thread has to be placed in the subcutaneous fat,

between fat and muscle (3 to 5 mm deep)

Choose the right plane

Straight Laying

Products used :

• 3 FA threads per side. 1 box for 1

face

Advantages :

• Simple and Efficient for small and

medium ptosis

Direct Effect :

• Malar Fat Pad support

• Lower jowl rectification

Indirect effect :

• Revive the look

• Neck Retention

Inversed V with temporal suture

Products used :

• 2 FA threads per side

Advantages :

• Simple and Efficient for small

and medium ptosis

• Retention possibility

Direct Effect :



Indirect effect :

• Revive the look

• Neck Retention

X Laying

Products used :

• 4 or 5 FA threads per side

Advantages :

• Very good suspension

• Possibility to pass 1

additional thread

Direct Effect :



Indirect effect :

• Revive the look

• Neck Retention

Y Laying

Products used :

• 1 FY + 1 FA threads per side

Advantages :


• Possibility to retighten

Direct Effect :


Indirect effect :

• Neck Retention

Easylift® (Dr Guillo)

Products used :

• 1 FY + 1 FA threads per side

Advantages :


• Possibility to retighten

Direct Effect :


Indirect effect :

• Neck Retention

Special thanks to Dr Denis Guillo and the SOMEREFs

Threads + Fat grafting +++

Threads + Hyaluronic Acid +++

Threads + Peeling +++

Treatments’ Combination

STRAIGHT LAYING

How to introduce the

needles properly

Present the needdle

perpendiculary to the skin

With that simple procedure once inserted , there will be no risk of

extrusion of the thread nor any anaesthetic node

Once the needdle introduced, tilt it

and push the needle under the skin

Punct perpendiculary to the skin

at about 3 mm depth

STRAIGHT LAYING

Drawing Anaesthesia, incision, 1st needle

2nd needle Other threads

STRAIGHT LAYING

Sitting Position

Traction on thread / pushing on tissue

Sitting position

Final traction /cutting

STRAIGHT LAYING

PRE CARE Antiseptic shampoo eve and morning,

Preventive antibiotic treatment (Amoxicillin – Augmentin or eq).

Light oral sedation (hydroxyzine - Atarax or eq.)

POST CARE Preventive antibiotic treatment,

No massage for 2 weeks,

Soft cleaning from bottom to top,

No bandage, no compression garment, quiet life …

Sleep on back if possible.

Visit before 8 days to control and adjust

PRECAUTIONS

COMPLICATIONS

Complication Answer

Per Operative hematoma Press and wait

Oedema 1 hour to 1 week

Slight temporary pain Conventional analgesic

i.e. Paracetamol

Inflammatory reaction Conventional anti- inflammatory

---> look for sepsis

Sepsis Take out the thread

Antibiotic coverage

Visibility of a thread path Before 8 days : unhook the thread

After 8 days : Filler

Visit before 8 days to control and adjust

Good patient selection / Good indication

Realistic expectations

Strong Aseptia

Work quietly

Good settings (not too much over correction)

Technically superior thread

THE WAY TO SUCCESS

RESULTS

Results are visible in 2 steps

In addition to the immediate effect, the results

still improve during the months following the

intervention.

2013 Pre Op

RESULT PRE AND POST

Doctor Glancey - UK

After 6 weeks After 3 Weeks 2013 Per Op

Pre Op

RESULT PRE AND POST

Doctor Chambers - UK

After 6 months

2013 Pre Op

RESULT PRE AND POST

Doctor Glancey - UK

2014 After 8 Months

Day 0 3 months

RESULTS PRE AND POST

Dr Guillo - France

PreOp PostOp 1 Year


Dr Sakaï - Japan

PreOp 1 month


Akiko Clinic - Japan

PreOp 3 weeks


Dr Freteur - Belgium

Day 0 1 year


Dr Foumenteze - France

Day 0 6 months


Dr Lamquin - France

Day 0 1 year


Dr Foumenteze - France

Day 0 3 months


Dr Guillo - France

Day 0 6 Months


Dr Guillo - France

Day 0 4 months


Dr Guillo - France


Dr Glancey - UK

Day 0 8 Months


Dr Dubois - France

Day 0 2 Days 8 Days

2007 - Before 2 months later


Dr Butnaru – France

2012 - 5 years later 1 month after 2nd Spring Thread


Dr Amgar – France

Day O 6 months


Dr David – France

Day 0 6 months


Dr David – France

Day 0 Post-Op


Dr Metanomski – France

Day 0 6 months


Dr Marthan – France

M + 2

M

M

Day 0 8 months

Before Post Op


Dr Malakovskaya - Russia

After

Before After 3 months


Dr Kruglik - Russia

2 or 3 threads on each side

Each thread enters behind the ear. One

half goes up, one half goes down.

The Threads are crossed (about 1 cm)

under the middle part of the neck.

PROPOSED SCHEMES NECK

Product recommendation

BL50-350 x6 + BASE 16-250 STE

or

FA6-300 x6 (thin skin)


Dr Glancey - UK

Day O 9 months

Before Post Op


Dr Amgar - France

EYEBROW

• One thread per side in V or U shape

• Adjust the angles according to the desired effect

Internal part Central part External part

Indication :

Small or medium breast

Minor or moderate ptosis

No augmentation wish

For small breast :

passage of long threads BL 50-350 in U

shape under the glande.

Or passage of threads BL 8-300 in L and J

position on each side of the breast.

For standard breast :

Passage of 6 threads BL 8-300 and BL 50-

350 set up in X.

BREAST


Dr Chambers - UK


Fat grafting reinforced by Spring Thread®


Dr Chambers - UK



Dr Mart - Thailand


BUTTOCKS

According to the patient morphology

Passage of 4 threads BL 8-300 in L and J on

each side of each buttock

You can :

• Cross on to focus on the buttock

• Straight passage of threads BL 8-300

• Passage of Threads BL 50-350 in V

inverted shape with fixing the point of V

by deep suture or horizontal thread


Dr Chambers - UK

Before After 3 weeks

Reshaping using fat grafting and Spring Thread®


Dr Chambers - UK

SOMEREFs : French Scientific Society for Thread Lift

1. Long and bi oriented Thread (15 + 15 = 30 cm)

2. Controlled elasticity (20%) for natural and painless result

3. Very strong thread to give good suspension

4. Numerous cogs (24 per cm) for easy settings and better anchorage

5. Round cogs to avoid tissue injury and induce large fibrosis

6. Permanent and inert for longer secured lasting effect

7. Two long flexible blunt end needles minimizing operative risks

8. Simple laying techniques

9. 100% French production + CE Marked

10. Best value market price

10 reasons to prefer Spring

Thread®

Dominique Malard Owner and CEO

[email protected]

+33 / 663 23 62 88

1st SurgiConcept - D. Malard 92

Thank you !!

the ultimate generation of suspension...

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