macrofill microfillsebbinfinland.fi/wp-content/uploads/2018/02/lipo... · 5 years of basic research...

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The ADIP’SPIN centrifuge allows you to achieve both, the lipomodelling (MACROFILL and SPINFILL syringes) and microfilling (MICROFILL) protocols as well as the traditional lipofilling techniques or the PRP (Platelet Rich Plasma): 2 modes: . “Macrofill / Microfill” Mode (2 x 1000 rpm 1second and 1 x 2000 rpm 1 minute); . “Libre” Mode, from 100 to 3000 rpm, from 1 to 99 min. Supplied with: . 1 rotor with 6 slots and its 6 adapters for Macrofill / Microfill; . 1 rotor with 12 slots and its 12 adapters (10 cc syringes or tubes of PRP harvested blood whose height does not exceed 12 cm). Reference: ADIPACKR6-12 Additional rotors are available for sale: . 6 slot rotor and its 6 adapters: reference ADIP-R6P; . 6 slot rotor only: reference ADIP-R6; . 12 slot rotor and its 12 adapters: reference ADIP-R12P. GS086 - A - V07 - 2015/04 ( ( ( Recreating harmonious bodies for a new vision of rebirth. MACROFILL ® , MICROFILL ® INNOVATIVE SYSTEMS FOR LIPOMODELLING AND MICROFILLING The concept is based on a new technique, carried out in a closed circuit, relying on more than 5 years of basic research on the adipose tissue. This technique preserves the cell survival and thus improves graft harvesting thanks to: . An aspiration with a low depression which will limit the death of fat cells (1); . A multi-hole lipoaspiration cannula calibrated to harvest and inject small adipose lobules which will be easily vascularized (2); . An atraumatic washing protocol with short and low duration speed centrifugations, thanks to a dedicated program of the ADIP’SPIN centrifuge (3, 4, 5, 6). This allows: . To eliminate toxic molecules (3, 4, 5); . To significantly reduce the inflammation of the adipose tissue (4). Measurement of the oil and the interstitial fluid in the adipose tissue after treatment with each method. Thanks to a gentle manipulation of the tissue and the successive rinsing, MICROFILL and MACROFILL allow to greatly limit the secretion of inflammatory molecules. Macrofill / Microfill Decantation Lipostructure Measurement of the secretion of the inflammatory cytokines MCP-1 by the adipose tissue after treatment with each method. 1 - Mechanical factors influencing fat cell transplants quality ; Ould-Ali D. IFAT 2010. Dallas. Oct 23. 2 - Development of micro-injection as an innovative autologous fat graft technique:The use of adipose tissue as dermal filler ; Nguyen PS, Desouches C, Gay AM, Hautier A, Magalon G. J Plast Reconstr Aesthet Surg. 2012 Dec; 65 (12): 1692-9. 3 - New insights into lidocaine and adrenaline effects on human adipose stem cells ; Girard AC, Atlan M, Bencharif K, Gunasekaran MK, Delarue P, Hulard O, Lefebvre-d’Hellencourt C, Roche R, Hoareau L, Festy F. Aesthetic Plast Surg. 2013 Feb; 37 (1): 144-52. 4 - Effect of centrifugation and washing on adipose graft viability: A new method to improve graft efficiency ; Hoareau L, Bencharif K, Girard AC, Gence L, Delarue P, Hulard O, Festy F, Roche R. J Plast Reconstr Aesthet Surg. J Plast Reconstr Aesthet Surg. 2013 May; 66 (5): 712-9. 5 - Local anesthetics have a major impact on viability of preadipocytes and their differentiation to adipocytes ; Keck M.Zeyda M, Gollingre K, Buriak S, Kamolz LP, Frey M, Stulnig TM. Plast Reconstr Surg. 2010 Nov; 126 (5): 1500-5. 6 - Effects of a new centrifugation method on adipose cell viability for autologous fat grafting ; Ferraro GA, De Francesco F.Tirino V, Cataldo C, Rossano F, Nicoletti G, D’Andrea F. Aesthetic Plast Surg. 2011 Jun; 35 (3): 341-8. The MACROFILL, MICROFILL, FEELSAFE, EASYFEEL & SPINFILL products carry the CE marking. These products are designed by Adip’sculpt company and manufactured by ALCIS company - Besançon - France. This document is dedicated to health care professionals. According to the Medical Device Directive 93/42/EEC, the MACROFILL, MICROFILL, FEELSAFE, EASYFEEL & SPINFILL are Class IIa medical devices. They are manufactured by ALCIS for ADIP’SCULPT and distributed by Groupe Sebbin. They are intended to be used in Plastic, Reconstructive or Aesthetic surgery to enhance the volume of deficient intra and sub-dermal areas through provision of adipose lobules. These devices are CE marked by the notified body BSI #0086. Please read carefully the instructions for use before using. ( ( Bibliography MACROFILL ® , MICROFILL ® INNOVATIVE SYSTEMS FOR LIPOMODELLING AND MICROFILLING FEELSAFE ® , EASYFEEL ® SINGLE-USE KITS FOR LIPOFILLING ADIP’SPIN ® CENTRIFUGE ( ( The ADIP’SPIN centrifuge with the tubes of the MICROFILL kit in the 6 slot rotor. Macrofill / Microfill (2000 rpm, 1 min) Decantation Lipostructure (3000 rpm, 3 min) % Oil (cell death) 6 % 2 % 18 % % Interstitial fluid 6 % 24 % 5 % % Adipose tissue 88 % 74 % 77 % 180- 160- 140- 120- 100- 80- 60- 40- 20- 0 % MCP-1 secreted 48H CENTRIFUGE ADIP’SPIN ® ( Preservation of the viability of the tissue, and elimination of the interstitial fluid Limitation of the adipose tissue inflammation The ADIP’SPIN centrifuge with SPINFILL syringes placed directly into the 6 slot rotor. The ADIP’SPIN centrifuge with the 12 slot rotor. DISTRIBUTOR: GROUPE SEBBIN SAS 39, Parc d’Activités des Quatre Vents 95650 Boissy l’Aillerie - France Tel.: +33 1 34 42 13 28 Fax: +33 1 34 42 16 88 www.sebbin.com INTERNATIONAL OPERATIONS: Sebbin Benelux SPRL: Tel.: +32 3 451 26 81 - Fax: +32 3 451 26 89 Email: [email protected] Sebbin Deutschland GmbH: Tel.: +49 2102 70 88 00 0 - Fax: +49 2102 70 88 00 99 Email: [email protected] Groupe Sebbin SAS, France: Tel.: +33 1 34 42 13 28 - Fax: +33 1 34 42 16 88 Email: [email protected] Sebbin Iberica Productos Medicos, S.L.: Tel.: +34 93 159 3003 - Fax: +34 93 676 3053 Email: [email protected] Sebbin Suisse Sarl: Tel.: +41 43 336 72 30 - Fax: +41 43 336 72 36 Email: [email protected] Sebbin UK Ltd: Tel.: 0800 652 4028 - Fax: +4433 0088 9575 Email: [email protected] ( BENEFITS EXE-BRO-4VOLETS-MACROFILL-MICROFILL-FEELSAFE-EASYFEEL-ADIP'SPIN-V2-ANGLAIS-Chgt adresse.indd 1 22/04/2015 14:50

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Page 1: MACROFILL MICROFILLsebbinfinland.fi/wp-content/uploads/2018/02/lipo... · 5 years of basic research on the adipose tissue. This technique preserves the cell survival and thus improves

The ADIP’SPIN centrifuge allows you to achieve both, the lipomodelling (MACROFILL and SPINFILL syringes) and microfill ing (MICROFILL) protocols as well as the traditional lipofill ing techniques or the PRP (Platelet Rich Plasma):

2 modes: . “Macrofill / Microfill” Mode (2 x 1000 rpm 1second and 1 x 2000 rpm 1 minute); . “Libre” Mode, from 100 to 3000 rpm, from 1 to 99 min.

Supplied with: . 1 rotor with 6 slots and its 6 adapters for Macrofill / Microfill; . 1 rotor with 12 slots and its 12 adapters (10 cc syringes or tubes of PRP harvested blood whose height does not exceed 12 cm).Reference: ADIPACKR6-12

Additional rotors are available for sale:

. 6 slot rotor and its 6 adapters: reference ADIP-R6P;

. 6 slot rotor only: reference ADIP-R6;

. 12 slot rotor and its 12 adapters: reference ADIP-R12P.

GS0

86 -

A -

V07

- 2

015/

04 ( ( (Recreating harmonious bodies for a new vision of rebirth.

MACROFILL®, MICROFILL®

INNOVATIVE SYSTEMS FOR LIPOMODELLING AND MICROFILLING

The concept is based on a new technique, carried out in a closed circuit, relying on more than 5 years of basic research on the adipose tissue.

This technique preserves the cell survival and thus improves graft harvesting thanks to:

. An aspiration with a low depression which will limit the death of fat cells (1); . A multi-hole lipoaspiration cannula calibrated to harvest and inject small adipose lobules which will be easily vascularized (2); . An atraumatic washing protocol with short and low duration speed centrifugations, thanks to a dedicated program of the ADIP’SPIN centrifuge (3, 4, 5, 6). This allows:

. To eliminate toxic molecules (3, 4, 5); . To significantly reduce the inflammation of the adipose tissue (4).

Measurement of the oil and the interstitial fluid in the adipose tissue after treatment with each method.

Thanks to a gentle manipulation of the tissue and the successive rinsing, MICROFILL and MACROFILL allow to greatly limit the secretion of inflammatory molecules.

Macrofill / Microfill Decantation Lipostructure

Measurement of the secretion of the inflammatory cytokines MCP-1 by the adipose tissue after treatment with each method.

1 - Mechanical factors influencing fat cell transplants quality ; Ould-Ali D. IFAT 2010. Dallas. Oct 23.2 - Development of micro-injection as an innovative autologous fat graft technique: The use of adipose tissue as dermal filler ; Nguyen PS, Desouches C, Gay AM, Hautier A, Magalon G. J Plast Reconstr Aesthet Surg. 2012 Dec; 65 (12): 1692-9.3 - New insights into lidocaine and adrenaline effects on human adipose stem cells ; Girard AC, Atlan M, Bencharif K, Gunasekaran MK, Delarue P, Hulard O, Lefebvre-d’Hellencourt C, Roche R, Hoareau L, Festy F. Aesthetic Plast Surg. 2013 Feb; 37 (1): 144-52.4 - Effect of centrifugation and washing on adipose graft viability: A new method to improve graft efficiency ; Hoareau L, Bencharif K, Girard AC, Gence L, Delarue P, Hulard O, Festy F, Roche R. J Plast Reconstr Aesthet Surg. J Plast Reconstr Aesthet Surg. 2013 May; 66 (5): 712-9.5 - Local anesthetics have a major impact on viability of preadipocytes and their differentiation to adipocytes ; Keck M.Zeyda M, Gollingre K, Buriak S, Kamolz LP, Frey M, Stulnig TM. Plast Reconstr Surg. 2010 Nov; 126 (5): 1500-5.6 - Effects of a new centrifugation method on adipose cell viability for autologous fat grafting ; Ferraro GA, De Francesco F.Tirino V, Cataldo C, Rossano F, Nicoletti G, D’Andrea F. Aesthetic Plast Surg. 2011 Jun; 35 (3): 341-8.

The MACROFILL, MICROFILL, FEELSAFE, EASYFEEL & SPINFILL products carry the CE marking.These products are designed by Adip’sculpt company and manufactured by ALCIS company - Besançon - France.

This document is dedicated to health care professionals. According to the Medical Device Directive 93/42/EEC, the MACROFILL, MICROFILL, FEELSAFE, EASYFEEL & SPINFILL are Class IIa medical devices. They are manufactured by ALCIS for ADIP’SCULPT and distributed by Groupe Sebbin. They are intended to be used in Plastic, Reconstructive or Aesthetic surgery to enhance the volume of deficient intra and sub-dermal areas through provision of adipose lobules. These devices are CE marked by the notified body BSI #0086. Please read carefully the instructions for use before using.

(( Bibliography MACROFILL®, MICROFILL®

INNOVATIVE SYSTEMS FOR LIPOMODELLING AND MICROFILLING

FEELSAFE®, EASYFEEL® SINGLE-USE KITS FOR LIPOFILLING

ADIP’SPIN®

CENTRIFUGE

((

The ADIP’SPIN centrifuge with the tubes ofthe MICROFILL kit in the 6 slot rotor.

Macrofill / Microfill (2000 rpm, 1 min) Decantation Lipostructure

(3000 rpm, 3 min)

% Oil (cell death) 6 % 2 % 18 %

% Interstitial fluid 6 % 24 % 5 %

% Adipose tissue 88 % 74 % 77 %

180-

160-

140-

120-

100-

80-

60-

40-

20-

0

% M

CP-

1 se

cret

ed

48H

CENTRIFUGE

ADIP’SPIN® (

Preservation of the viability of the tissue, and elimination of the interstitial fluid

Limitation of the adipose tissue inflammationThe ADIP’SPIN centrifuge with SPINFILL

syringes placed directly into the 6 slot rotor.

The ADIP’SPIN centrifuge withthe 12 slot rotor.

D I S T R I B U TO R :

GROUPE SEBBIN SAS 39, Parc d’Activités des Quatre Vents 95650 Boissy l’Aillerie - France Tel.: +33 1 34 42 13 28 Fax: +33 1 34 42 16 88www.sebbin.com

I N T E R N AT I O N A L O P E R AT I O N S : Sebbin Benelux SPRL: Tel.: +32 3 451 26 81 - Fax: +32 3 451 26 89 Email: [email protected] Deutschland GmbH: Tel.: +49 2102 70 88 00 0 - Fax: +49 2102 70 88 00 99 Email: [email protected] Groupe Sebbin SAS, France: Tel.: +33 1 34 42 13 28 - Fax: +33 1 34 42 16 88 Email: [email protected] Iberica Productos Medicos, S.L.:Tel.: +34 93 159 3003 - Fax: +34 93 676 3053 Email: [email protected] Suisse Sarl: Tel.: +41 43 336 72 30 - Fax: +41 43 336 72 36 Email: [email protected] UK Ltd: Tel.: 0800 652 4028 - Fax: +4433 0088 9575 Email: [email protected]

(BENEFITS

EXE-BRO-4VOLETS-MACROFILL-MICROFILL-FEELSAFE-EASYFEEL-ADIP'SPIN-V2-ANGLAIS-Chgt adresse.indd 1 22/04/2015 14:50

Page 2: MACROFILL MICROFILLsebbinfinland.fi/wp-content/uploads/2018/02/lipo... · 5 years of basic research on the adipose tissue. This technique preserves the cell survival and thus improves

INDICATIONS

This single use kit allows to work in a closed circuit for the harvesting, treatment and reinjection of large volumes of fat for lipomodelling.

BENEFITS

. Liposuction preserves the cell survival thanks to the use of a controlled vacuum 60 cc syringe. Keeping low vacuum during harvesting reduces adipocyte death (1).

. Multi-hole lipoaspiration cannulas calibrated for collecting small adipose lobules. MACROFILL allows you to harvest and inject small adipose lobules which will be easily vascularized, thus optimizing the graft harvesting (2).

.Atraumatic washing protocol with short duration and low speed centrifugation thanks to a dedicated program of the ADIP’SPIN centrifuge. This unique protocol preserves the cell and tissue survival (3, 4, 5, 6). .The technique limits also significantly post-operative inflammation of the adipose tissue (4).

. Removable piston rod of the syringe, which allows centrifuging the syringe directly in the ADIP’SPIN centrifuge;. Treatment of the adipose tissue, from harvesting to injection, in a totally closed circuit ensuring an optimum safety for the patient;. Complete single-use sterile kit.

(MACROFILL®

AN INNOVATIVE SYSTEM FOR LIPOMODELLING

Tests performed with a 60 cc syringe and a 3.5 mm Ø x 200 mm cannula

Recommendedmaximum vacuum

(according to Ould-Ali 2010)for an optimal

survival of adipose tissue

Medium vacuum exertedduring the incrementationon the controlled vacuum

SPINFILL syringe

Vacuum exertedon the same syringewithout increment

(piston at maximum in one go)

- 0.55 bar - 0.45 bar - 0.77 bar

NEw KITS FOR LIPOFILLING OF SMALL VOLUME OF FAT

.Kit suitable for all indications requiring lipomodelling: MACROFILL can treat from 120 to 360 cc of adipose tissue in a single operation and beyond, as the SPINFILL syringes can be used several times in the course of the same operation (up to 1440 cc);. SPINFILL 60 cc incremental harvesting syringes offering optimal ergonomics for the practitioner;.Kit containing all the sterile elements necessary for the realization of the operating procedure;. Additional SPINFILL syringes are available for more comfort and speed for treating more than 360 cc of adipose tissue during the same operation.

The MACROFILL kit is packaged under double-wrapped blister pack and sold individually. It contains all the elements required for the procedure, from harvesting to reinjection.

Contents of the MACROFILL kit:

.6 SPINFILL 60 cc syringes with incremental “controlled vacuum”.1 infiltration cannula.1 sampling cannula Ø 3.5 mm x 200 mm, 20 holes.1 sampling cannula Ø 3.5 mm x 250 mm, 20 holes.10 BD Luer-Lock syringes 10 mL.1 injection cannula Ø 2.1 mm x 130 mm.1 injection cannula Ø 2.1 mm x 200 mm.1 needle 18 Gauge.1 NOKOR needle 18 Gauge.2 Luer-Lock adapter end-pieces.12 Luer-Lock caps.1 lock nut for the centrifuge’s rotor.1 blister rack for the syringes

The MACROFILL kit is used with the ADIP’SPIN centrifuge.

The SPINFILL syringes allow you to control the vacuum during removal of the adipose tissue with a unique notched piston. The low vacuum improves the survival of the adipocytes (1).

They are sold sterile for single use, and allow you to perform the procedure in a closed circuit and can be placed directly into the rotor of the centrifuge.

The SPINFILL syringes kit is packaged in a box containing:3 individual bags of 2 syringes including each:. 4 Luer-Lock caps. 2 Luer-Lock adapter end-pieces. 1 nut for the rotor

The SPINFILL syringes are used with the ADIP’SPIN centrifuge.

IndicationsUse of the EASYFEEL, FEELSAFE and MICROFILL kits is indicated for carrying out lipofilling as part of aesthetic or reconstructive surgery, to enhance the volume of deficient intra and sub-dermal areas through provision of adipose microlobules. Use of kits is especially indicated for rejuvenation of the face but also for filling small volumes over all parts of the body.

MICROFILL®

AN INNOVATIVE SYSTEM FOR MICROFILLING

MICROFILL allows sampling and injection of very fine adipose lobules which will be easily vascularized, thus optimizing graft acceptance. The very thin cannula permits an easy and atraumatic injection.

The MICROFILL kit is packaged under double-wrapped blister pack and sold individually. It contains all the elements required for the procedure, from harvesting to reinjection.

Contents of the MICROFILL kit:

.1 infiltration cannula Ø 2.5 mm x 150 mm.4 aspiration syringes 10 cc BD.1 sampling cannula Ø 2.1 mm x 150 mm, 8 holes (1.2 mm aperture) .1 transfer cannula Ø 3.5 mm x 130 mm.2 tissue transfer tubes.2 Luer-Lock adapter end-pieces.4 injection syringes 1 cc.1 injection cannula Ø 0.9 mm x 50 mm.1 injection cannula Ø 1.4 mm x 100 mm.1 needle 18 Gauge.1 lock nut for rotor

The MICROFILL kit is used with the ADIP’SPIN centrifuge.

Reference: 2054-KTA3-S

Reference: 2054-KTA2-S

Reference: 2054-KTA3.2-S-B06

Microfilling: a new technique for facial rejuvenation

FEELSAFE®

LIPOFILLING “ALL-IN-ONE”

This single-use kit contains all the items for carrying out the lipofilling technique with the following innovations: 1 Improvement in acceptance of the graft: The micro-aspiration cannula allows protection of tissue and collection of microlobules which will be better vascularized after injection.2 Decrease in the risk of infection: The sampling syringes allow easy manipulation of the tissue without being in contact with the air due to the specific caps.3 Ease and rapidity: Centrifugation of the syringes is performed a single time using the equipment from the operating room. The kit reinjection cannulas are used directly with these syringes.4 Serenity: An “all-in-one” kit containing all the items necessary for the technique.

The FEELSAFE kit is packaged under double-wrapped blister pack and sold individually.

Contents of the FEELSAFE kit:

EASYFEEL®

THE FUNDAMENTALS OF LIPOFILLING

This single-use kit provides you with the necessary instruments for carrying out the lipofilling technique:1 Sterile, single-use cannulas for lipoaspiration and for reinjection brought together in all-in-one packaging; 2 Using them saves time; 3 Syringe caps eliminate the risk of infection for patient.

The EASYFEEL kit is packaged under single double-wrapped bag and sold by 5 units.

Contents of the EASYFEEL kit:

Reference: 2054-KTA4-2

.1 infiltration cannula 2.5 mm x 150 mm.4 aspiration syringes 10 cc BD.1 sampling cannula Ø 2.1 mm x 150 mm, 8 holes (1.2 mm aperture).4 Luer-Lock stoppers

.4 “removable” caps for 10 cc syringes.2 Luer-Lock adapter end-pieces.4 injection syringes 1 cc.1 injection cannula Ø 1.1 mm x 50 mm.1 injection cannula Ø 1.4 mm x 100 mm

.1 infiltration cannula Ø 2.5 mm x 150 mm .1 sampling cannula Ø 2.1 mm x 150 mm, 8 holes (1.2 mm aperture). 4 Luer Lock stoppers

.4 “removable” caps for 10 cc syringes.2 Luer-Lock adapter end-pieces.1 injection cannula Ø 1.1 mm x 50 mm.1 injection cannula Ø 1.1 mm x 70 mm

Reference: 2054-KTA2-2

( (

(

(

Increase the graft harvest rates with a maximum preservation of adipose lobules

Very significant reduction of infectious risk

Complete single-use sterile kit

A SINGLE USE STERILE KIT

SPINFILL®

CONTROLLED VACUUM SYRINGE

(

KITS FOR LIPOMODELLING

A SINGLE USE STERILE KIT

A SINGLE USE STERILE KIT

A SINGLE USE STERILE KIT

BENEFITS

BENEFITS

EXE-BRO-4VOLETS-MACROFILL-MICROFILL-FEELSAFE-EASYFEEL-ADIP'SPIN-V2-ANGLAIS-Chgt adresse.indd 2 22/04/2015 14:50