The Ultimate Generation of Suspension Thread. For Aesthetic Medicine and Cosmetic Surgery

Transcription

1 The Ultimate Generation of Suspension Thread For Aesthetic Medicine and Cosmetic Surgery

2 SUMMARY Company Aging & Lifting Spring Thread main characteristics Implantation Methods and Recommendations Clinical results

3 COMPANY 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

4 LOCATION Tourcoing nearby Lille Between Brussels, Paris and London Known for textile, mining and biotech industry.

5 PRODUCTION Production : 100% Made in France (2 manufacturing plants) Strong commitment for Quality ISO CE Marked (Medical Device class IIb) To Date : More than 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,

6 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

7 Aging? Facial Aging? Tissue Alteration : Fillers Cutaneous Modification : Peeling Tissue Loosening : Lifting Other rejuvenation methods : Botox, Lasers, Co2, Leds

8 Facial Aging! The aging process changes the main structures of the face, including skin, fat, muscles and bone structure. 35 years 45 years 55 years *Valeant Aesthetics

9 Aging has to be considered as GLOBAL Phenomenon Answer Solutions Skin structure modification Loss of volume Ptosis Skin caring Filling Lifting Cosmetics, skin boosters, Mesotherapy, Peelings, Lasers Injectable, Fat grafting Surgical Lifting Thread Lifting 35 years 45 years 55 years *Valeant Aesthetics

10 What about Ptosis? Surgical Lifting Lifting Absorbable Threads Biochemical Stimulation Thread Lifting Permanent Threads Mechanical Suspension

11 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?

12 Vertical traction Natural support of adipose tissues without modification of the face features Special thanks to Dr Denis Guillo and the SOMEREFs

13 Advantages of Thread Lift 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.

14 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

15 Do not confuse stimulation and suspension Absorbable : Rejuvenation Permanent : Suspension Between Biochemical stimulation or Mechanical Suspension, the doctor will choose the best strategy according to the profile and to the expectations of his patient.

16 PRODUCTS ON THE MARKET

17 APTOS Non elastic monofilament of polypropylene 5 Aggressive cogs per cm Inconstant result, extrusion risk Deadpan aspect, figé, definitive positioning at starting Painful surtension

18 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

19 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

20 PRODUCTS ON THE MARKET SPRING THREAD Body SPRING THREAD Face SILHOUETTE LIFT UPACTIV HAPPYLIFT résorbable APTOS Fil lisse Copyright SOMEREFs

21 A NEW ERA IN SUSPENSION THREADS Spring Thread answers optimally to market expectations PATIENTS REQUESTS : Security Long Term Action PRACTITIONNERS NEEDS : Reliability Simplicity Spring Thread ANSWERS : Elasticity Flexibility Strength Excellent fixation

22 4 MAJOR INNOVATIONS Silicone Polyester Core Moulded and non aggressive cogs Flexibility and elasticity Solidity and controlled elasticity Excellent Fixation in the tissues Permanent Thread Long Term Action flexible, elastic, 24 convergent 3D cogs/cm

23 SPRING THREAD flexible, elastic, 24 convergent 3D cogs/cm

24 Spring Thread Silicone The better accepted material by the body 100% Biocompatible and Biostable No Inflammatory reaction No extrusion or migration Good fibrosis

25 BIOCOMPATIBILITY Tests realized with a certified laboratory on finished product Conducted Tests Parameters Standards Standards Title Name and Reference Test Conclusion Cytotoxicity ISO : 2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity L929 MTT Cytotoxicity Test* (TOXIKON G1) Non-cytotoxic Sensitization ISO : 2002 Amended 2006 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Delayed Type Hypersensitivity Kligman Maximization Test* (TOXIKON G3) Non-irritant Irritation and intracutaneous reactivity Acute systematic Toxicity ISO : 2002 Amended 2006 ISO : 2006 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Delayed Type Hypersensitivity Biological Evaluation of Medical Devices Part 6: Tests for Systemic Toxicity Intracutaneous Injection Test* (TOXIKON G2) Systemic Injection Test* (TOXIKON G4) Non-irritant Non-toxic ISO : 2007 Biological Evaluation of Medical Devices Part 6: Tests for Local Effects After Implantation Subchronic Toxicity ASTM F Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone Subcutaneous Implantation Test* (13 weeks) (TOXIKON G10) Non-irritant ASTM F Standard Practice for Short Term Screening of Implant

26 Conducted Tests Parameters Standards Standards Title Name and Reference Test Conclusion Genotoxicity Carcinogenicity Reproductive Toxicity ISO : 2003 OECD 473 (21 July 1997) ISO : 2003 OECD 471 (21 July 1997) Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity Guidelines for the Testing of Chemicals, In vitro Mammalian Chromosomal Aberration Test Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity Guidelines for the Testing of Chemicals, Bacterial Reverse Mutation Test (Ames Test) Chromosomal Aberration Assay* (TOXIKON G6) Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay* (TOXIKON G7) Non-clastogenic Non-mutagenic Implantation Hemocompatibility Pyrogenicity** ISO : 2007 ASTM F ASTM F ISO : 2002 Amended 2006 ISO : 2006 USP 32 Formula 27 :2009 Biological Evaluation of Medical Devices Part 6: Tests for Local Effects After Implantation Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone Standard Practice for Short Term Screening of Implant Biological Evaluation of Medical Devices Part 4: Selection of Tests for Interactions with Blood Subcutaneous Implantation Test* (2 weeks) (TOXIKON G9) Hemolysis Human Blood Indirect Contact* (TOXIKON G8) Biological Evaluation of Medical Devices Part 6: Tests for Systemic Toxicity Rabbit Pyrogen Test* Non-irritant Non-hemolytic Non-pyrogenic (TOXIKON G5) <151> Pyrogen Test Non-pyrogenic

27 STERILITY Tests realized with a certified laboratory on finished product Sterilization realized by a certified sterilizer subcontractor Components Security Standards Bioburden ISO : 2006 ISO : 2007 ISO : 2008 Tests Name / Supplier Sterilization of medical devices Microbiological methods : Determination of a population of microorganisms on products Sterilization of health care products Ethylene oxide : Requirements for development, validation and routine control of sterilization process for medical devices Sterilization of health care products Ethylene oxide : Directive on the application of ISO Conclusion Conform Conform Conform Sterilization ISO : 2006 Sterilization of health care products Biological indicators : General requirements Conform ISO : 2006 Sterilization of health care products Biological indicators : Biological indicators for ethylene oxide sterilization Conform ISO : 2009 Biological evaluation of medical devices : Ethylene oxide sterilization residuals Conform Residual ethylene oxide, ethylene chlorhydrin and ethylene glycol ISO : 2008 ISO : 2007 ISO : 2008 Biological evaluation of medical devices : Ethylene oxide sterilization residuals Sterilization of health care products Ethylene oxide : Requirements for development, validation and routine control of sterilization process for medical devices Sterilization of health care products Ethylene oxide : Directive on the application of ISO Conform Conform Conform

28 IMPLANTATION TECHNIQUES

29 PATIENT SELECTION 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,

30 GOOD INDICATION Face oval Nasolabial folds Marionette Lines Cheeks Eyebrows

31 BAD INDICATION Too important sagging Too much fat Too much skin Elastosis wrinkles or heliodermic skin

32 STRONG ASEPTIA IS FUNDAMENTAL

33 Implantation : Subcutaneous Fat No Anatomical Risk! 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) Soft needle : no risk to touch nerves or vessels

34 Choose the right plane The thread has to be placed in the subcutaneous fat, between fat and muscle (3 to 5 mm deep)

35 Straight Laying Direct Effect : Malar Fat Pad support Lower jowl rectification Indirect effect : Revive the look Neck Retention Products used : 3 FA threads per side. 1 box for 1 face Advantages : Simple and Efficient for small and medium ptosis

36 Inversed V with temporal suture Direct Effect : Malar Fat Pad support Lower jowl rectification Indirect effect : Revive the look Neck Retention Products used : 2 FA threads per side Advantages : Simple and Efficient for small and medium ptosis Retention possibility

37 X Laying Direct Effect : Malar Fat Pad support Lower jowl rectification Indirect effect : Revive the look Neck Retention Products used : 4 or 5 FA threads per side Advantages : Very good suspension Possibility to pass 1 additional thread

38 Y Laying Direct Effect : Lower jowl rectification Indirect effect : Neck Retention Products used : 1 FY + 1 FA threads per side Advantages : Very good suspension Possibility to retighten

39 Easylift (Dr Guillo) Direct Effect : Lower jowl rectification Indirect effect : Neck Retention Products used : 1 FY + 1 FA threads per side Advantages : Very good suspension Possibility to retighten Special thanks to Dr Denis Guillo and the SOMEREFs

40 Treatments Combination Threads + Fat grafting +++ Threads + Hyaluronic Acid +++ Threads + Peeling +++

41 STRAIGHT LAYING

42 How to introduce the needles properly Present the needdle perpendiculary to the skin Punct perpendiculary to the skin at about 3 mm depth Once the needdle introduced, tilt it and push the needle under the skin With that simple procedure once inserted, there will be no risk of extrusion of the thread nor any anaesthetic node

43 STRAIGHT LAYING Drawing Anaesthesia, incision, 1st needle

44 STRAIGHT LAYING 2nd needle Other threads

45 STRAIGHT LAYING Sitting Position Traction on thread / pushing on tissue Sitting position Final traction /cutting

46 PRECAUTIONS 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

47 COMPLICATIONS Complication Answer Per Operative hematoma Press and wait Oedema 1 hour to 1 week Slight temporary pain Inflammatory reaction Sepsis Visibility of a thread path Conventional analgesic i.e. Paracetamol Conventional anti- inflammatory ---> look for sepsis Take out the thread Antibiotic coverage Before 8 days : unhook the thread After 8 days : Filler Visit before 8 days to control and adjust

48 THE WAY TO SUCCESS Good patient selection / Good indication Realistic expectations Strong Aseptia Work quietly Good settings (not too much over correction) Technically superior thread

49 RESULTS Results are visible in 2 steps In addition to the immediate effect, the results still improve during the months following the intervention.

50 RESULT PRE AND POST Doctor Glancey - UK 2013 Pre Op 2013 Per Op After 3 Weeks After 6 weeks

51 RESULT PRE AND POST Doctor Chambers - UK Pre Op After 6 months

52 RESULT PRE AND POST Doctor Glancey - UK 2013 Pre Op 2014 After 8 Months

53 RESULTS PRE AND POST Dr Guillo - France Day 0 3 months

54 RESULTS PRE AND POST Dr Sakaï - Japan PreOp PostOp 1 Year

55 RESULTS PRE AND POST Akiko Clinic - Japan PreOp 1 month

56 RESULTS PRE AND POST Dr Freteur - Belgium PreOp 3 weeks

57 RESULTS PRE AND POST Dr Foumenteze - France Day 0 1 year

58 RESULTS PRE AND POST Dr Lamquin - France Day 0 6 months

59 RESULTS PRE AND POST Dr Foumenteze - France Day 0 1 year

60 RESULTS PRE AND POST Dr Guillo - France Day 0 3 months

61 RESULTS PRE AND POST Dr Guillo - France Day 0 6 Months

62 RESULTS PRE AND POST Dr Guillo - France Day 0 4 months

63 RESULTS PRE AND POST Dr Glancey - UK Day 0 8 Months

64 RESULTS PRE AND POST Dr Dubois - France Day 0 2 Days 8 Days

65 RESULTS PRE AND POST Dr Butnaru France Before 2 months later years later 1 month after 2 nd Spring Thread

66 RESULTS PRE AND POST Dr Amgar France Day O 6 months

67 RESULTS PRE AND POST Dr David France Day 0 6 months

68 RESULTS PRE AND POST Dr David France Day 0 Post-Op

69 RESULTS PRE AND POST Dr Metanomski France Day 0 6 months

70 RESULTS PRE AND POST Dr Marthan France M Day 0 M M months

71 RESULTS PRE AND POST Dr Malakovskaya - Russia Before Post Op After

72 RESULTS PRE AND POST Dr Kruglik - Russia Before After 3 months

73 PROPOSED SCHEMES NECK 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. Product recommendation BL x6 + BASE STE or FA6-300 x6 (thin skin)

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75 RESULTS PRE AND POST Dr Glancey - UK Day O 9 months

76 RESULTS PRE AND POST Dr Amgar - France Before Post Op

77 EYEBROW Internal part Central part External part One thread per side in V or U shape Adjust the angles according to the desired effect

78 BREAST Indication : Small or medium breast Minor or moderate ptosis No augmentation wish For small breast : passage of long threads BL in U shape under the glande. Or passage of threads BL in L and J position on each side of the breast. For standard breast : Passage of 6 threads BL and BL set up in X.

79 RESULTS PRE AND POST Dr Chambers - UK Before After 3 months Fat grafting reinforced by Spring Thread

80 RESULTS PRE AND POST Dr Chambers - UK Before After 3 months

81 RESULTS PRE AND POST Dr Mart - Thailand Before After 6 months

82 BUTTOCKS According to the patient morphology Passage of 4 threads BL in L and J on each side of each buttock You can : Cross on to focus on the buttock Straight passage of threads BL Passage of Threads BL in V inverted shape with fixing the point of V by deep suture or horizontal thread

83 RESULTS PRE AND POST Dr Chambers - UK Before After 3 weeks Reshaping using fat grafting and Spring Thread

84 RESULTS PRE AND POST Dr Chambers - UK

85 SOMEREFs : French Scientific Society for Thread Lift

86 10 reasons to prefer Spring Thread 1. Long and bi oriented Thread ( = 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 % French production + CE Marked 10. Best value market price

87 Thank you!! Dominique Malard Owner and CEO +33 / st SurgiConcept - D. Malard 92