LYMPHEDEMA PRODUCT CATALOG
175 years of the
Thuasne
Dear Customers, We are pleased to share our lymphedema solutions, including our new Mobiderm® Intimate Bra made possible by the dedication of our research and development, marketing, design, and industrial teams. In addition, we are excited to introduce lymphedema garments from our U.S. subsidiary, Therafirm®. Therafirm is a leading manufacturer of quality compression socks and hosiery and has been developing scientifically advanced compression products for more than 60 years. Together, Thuasne and Therafirm remain committed to providing innovative, efficient and adapted solutions to improve the mobility and the quality of life of patients.
Delphine Hanton Chief Executive Officer
Group
The know-how of the Thuasne Group is rooted in Saint-Étienne, having imagined, developed and produced medical devices for over 175 years, allowing everyone to take charge of their own health. As a result of the shared history of 6 generations of entrepreneurs, Thuasne offers specific, simple, adapted and innovative health solutions supporting mobility in over 85 countries. We offer our expertise to patients in the fields of orthopaedics (belts, orthoses), medical compression (phlebology, lymphology, healing), femininity (external breast prostheses, underwear) and home care.
“Made in Thuasne”: the ability to control the whole value chain Because Thuasne pursues the objective of offering patients and healthcare professionals effective, quality products, it can guarantee that its products are designed, produced and distributed using technologies controlled by the Group, after extensive accumulated experience.
Elizabeth Ducottet Chairman and CEO In everything we do, we believe in challenging the status quo. We believe that we must think differently.
Take care wisely
Our way of challenging the status quo is to manufacture our solutions by ensuring that they are efficient(1,2), medically proven(2,3,4), easy to use(1) and comfortable(2,5).
with Thuasne solutions
• 40 years of medical and technical expertise in compression devices • Network of specialized fitters • Expertise of our made-to-measure customer services • Recognized brands • Efficiency proven solutions • Individualized solutions all along the patient’s treatment
Be sure to inquire
about the possibility of lymphedema treatment products being covered by the Lymphedema Treatment Act.
Quality standards Some of our products comply with Oeko-Tex 100 standard(6). Thus Thuasne ensure that materials used for the manufacturing of our products are safe for the health and the environnement.
(1) Please refer to the internal CE data. (2) Mestre Interest of an auto adjustable night time compression sleeve (MOBIDERM Autofit in maintenance phase of upper extremity lymphedema: the MARILYN pilot RCT Support Care Cancer (25:2455 2462) 2017 Page 6 & 7. (3) Todd Mobiderm Autofit: an adjustable sleeve that enables patients to self manage lymphedema Chronic edema April 2018 (4) POLIT Prospective multicentre observational study of lymphedema therapy: POLIT study Pr Quéré Journal des maladies Vasculaires 2014. (5) Lymphatrex Expert: ETN 280 Dossier Textile Polyamide July Aug2017. (6) The list of products Oeko-Tex certified is available on demand.
3
LYMPHEDEMA PRODUCTS
Content
Management of Lymphedema Patients presenting lymphedema should benefit from coordinated management and receive information adapted to their needs.
The main objectives of the treatment are: • Reduction, then stabilization of the volume • Improvement of the extremity function • Prevention of complication risks • Patient education and psycho-social support
LYMPHEDEMA TREATMENTS
This chronic disease therefore requires continuous management, which can be split into two essential and complementary phases:
The reduction phase ����������������������������������������������������������������������������� 6 - Mobiderm technology �������������������������������������������������������������� 8 - Mobiderm bandages and pads ��������������������������������������������� 9 - Other bandaging supplies �������������������������������������������������������� 9 The maintenance phase ���������������������������������������������������������������������10 - Mobiderm Intimate Bra ��������������������������������������������������������������12 - Mobiderm Intimate Shorts ������������������������������������������������������ 14 - Mobiderm Standard ������������������������������������������������������������������ 16 - Mobiderm Autofit ���������������������������������������������������������������������� 18 - Biflex Self Adjust ������������������������������������������������������������������������� 22 - Ease Lymphedema �������������������������������������������������������������������� 26 - Ease Adjust ������������������������������������������������������������������������������������� 28 Fitting and measurement ����������������������������������������������������������������� 30 - Mobiderm fitting and care instructions ����������������������������30 - Mobiderm measurement tips �������������������������������������������������31
The REDUCTION phase
The MAINTENANCE phase
that will follow one another depending on the evolution of the lymphedema.
Medical compression is one of the key elements of the treatment . (8)
USEFUL THINGS TO KNOW
CARE INSTRUCTIONS
STANDARD DEVICE
CIRCULAR KNIT
FITTING INSTRUCTIONS
(8) Haute Autorité de Santé - La compression médicale dans le traitement du lymphœdème - Fiche BUTS 2010 French National Authority for Health - Medical Compression in the Treatment of Lymphedema - BUTS Sheet 2010
5
LYMPHEDEMA PRODUCTS
Thuasne Protocol
The reduction phase The reduction phase is also known as the intensive decongestive treatment. Its goal is to achieve maximum reduction of the edema to come as close as possible to the volume of the opposite healthy extremity. The main treatments used are:
The reduction phase is usually performed using multi-component bandages (1)
The advantage of bandages is that they can be repositioned over and over to ensure the best possible fit to successive variations in edema volume. There are different sorts of bandages and it is their combined use that reduces edema(2).
1
• Manual lymphatic drainage (MLD), carried out by a specifically trained lymphedema therapists, to stimulate and facilitate the circulation of the lymph by promoting the unblocking of the lymph nodes. • Reducing and draining bandages requiring the use of multi-component bandages which can be adapted to the volume and repositioned at will. • Coached physical activity under bandages to improve lymph circulation, regain mobility and flexibility.
2
PROTECT the skin PROTECTIVE COTTON BANDAGE In direct contact with the skin, this tubular cotton bandage provides tight containment of the extremity. Made of cotton, it provides soft(3) and lined protection of the skin weakened by the lymphedema.
MOBILIZE the edema BANDAGE Used under a reducing bandage or garment (e.g. adjustable wrap), the Mobiderm technology mobilizes edematous or indurated subcutaneous tissue.
• Skin care to prevent complications related to lymph accumulation. This phase may vary from one to several weeks, depending on the severity of the lymphedema, and can be renewed later.
3
CONTAIN the edema BIFLEXIDEAL SHORT-STRETCH BANDAGE A short-stretch bandage (<100% stretch) as the third layer helps with containment of the edema, as well as drainage in case of physical activity (high working pressure)(4).
(1) HAS – Dispositifs de compression médicale à usage individuel – Utilisation en pathologies vasculaires – Sept 2010 – Page 14 (Medical compression devices for individual use - Use in vascular pathologies) (2) European Wound Management Association (EWMA). Focus Document: Lymphoedema bandaging in practice. London: MEP Ltd, 2005. (3) Futura Tech - Du végétal aux textiles - Récolte, transformation et utilisation du coton (From plant to textile - Harvesting, processing and use of cotton). (4) Quéré - Prospective multicenter observational study of lymphedema therapy: POLIT study - Vascular Desease Journal - 2014 - Pages 4 et 5
7
LYMPHEDEMA PRODUCTS
Dimensions
is a medical device made up of foam blocks encased between two non-woven bandages.
The
Technology The can be used under a reducing bandage (in its bandage or pad forms), or incorporated into mobilizing garments.
Technology
Epidermis Dermis
Lymph flow
Due to the difference in pressure created between the support area of the blocks and their surrounding area, it promotes the flow of lymphatic fluid and optimizes the drainage efficacy(1).
Designation
Reference
25 cm x 25 cm 25 cm x 1 m
Small blocks 5 mm x 5 mm
371001 02502501 371001 03310001
20 cm x 1 m
Big blocks 15 mm x 15 mm
371001 03310002
Dimensions Skin
® Pads
10 cm x 3 m
® Bandages Designation
Reference
Small blocks 5 mm x 5 mm
372001 01030001
Big blocks 15 mm x 15 mm
372001 01030002
Biflex 16+ - Light Elastic Bandage Dimensions
8 cm x 5 m 10 cm x 3 m 10 cm x 5 m
Color
Reference
Beige
16000200850002 16000201030002 16000201050002
Biflex 17+ - Strong Elastic Bandage Dimensions
Color
Reference
Beige
17000200840002 17000201030002 17000201050002
EFFECTIVE
8 cm x 4 m 10 cm x 3 m 10 cm x 5 m
PRACTICAL
Biflexideal - Short Stretch Bandage
• Rapid volume reduction of the edema(2). •L ight and comfortable, it enables the patient to keep their freedom of movement(3).
COMFORTABLE
• Ability of the product to contour the extremity Conseils provides an adapted anatomical fit.
Patented
device
(4)
d’entretien
Dimensions
3 cm x 5 m 6 cm x 5 m 8 cm x 5 m 10 cm x 5 m
Color
Reference
White
11000200350000 11000200650000 11000200850000 11000201050000
Biplast - Adhesive Bandage Patented
2 SIZES OF BLOCKS
technology
SMALL BLOCKS
Dimensions
Standard products
Faster* availability
• More effective in highly indurated areasStandard products Faster* availability • Better adapted to small anatomies (pediatric patients, hands/foot, breast…) • Lower profile for discreet care
BIG BLOCKS • Better adapted along the extremity
(1) Todd – Mobiderm Autofit: an adjustable sleeve that enables patients to self-manage lymphedema – Chronic edema – April 2018 – Page 6 (2) Quéré - Prospective multicenter observational study of lymphedema therapy: POLIT study - Vascular Desease Journal – 2014 – Pages 4 and 5 (3) Mestre – Interest of an auto-adjustable night-time compression sleeve (MOBIDERM Autofit) in maintenance phase of upper extremity lymphedema: the MARILYN pilot RCT Support Care Cancer (25:2455-2462) – 2017 – Page 7 (4) Only in following countries: Algeria, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Morocco, Italy, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, United-Kingdom, USA
3 cm x 2.5 m 5 cm x 2.5 m 6 cm x 2.5 m 8 cm x 2.5 m 10 cm x 2.5 m 20 cm x 2.5 m
Color
Reference
White
20000100325000 20000201525000 20000200625000 20000100825000 20000201025000 20000202025000
Biflex Kit - Reusable Two Layer Compression System Dimensions
Reference
S1 (Layer 1: 10 cm x 4 m, Layer 2: 10 cm x 3.5 m) S1 (Layer 1: 10 cm x 4 m, Layer 2: 10 cm x 3.5 m) S1 (Layer 1: 10 cm x 4 m, Layer 2: 10 cm x 3.5 m)
17005020199999 17005020299999 17005020399999
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LYMPHEDEMA PRODUCTS
How to choose the right solution?
CON T
C
UPPER LIMB
MILD LYMPHEDEMA Stage 0 & I : Regular extremity shape Liquid consistency No skin folds <20% volume excess
This phase is conducted first with elastic compression garments which will be renewed regularly under the supervision of a healthcare professional.
MODERATE LYMPHEDEMA
CON T
LIZE BI
C
N AI
AIN & M NT O O
REST AND NIGHTTIME COMPRESSION
PELVIS/GENITAL
BREAST
Intimate Shorts
Intimate Bra
EASE ADJUST by THERAFIRM®
EASE OPAQUE by THERAFIRM®
EASE LYMPHEDEMA
CORE-SPUN by THERAFIRM®
STANDARD
EASE ADJUST
Stage II & Late II: Regular extremity shape Liquid consistency 20-40% volume excess
CONTAIN AND MOBILIZE
LOWER LIMB
STANDARD
by THERAFIRM®
Its role is to stabilize the volume of the reduced extremity in the inital phase, or even to continue the volume reduction, but also to avoid relapses and enable the patient to recover normal mobility.
AIN & M NT O O
LIZE BI
As soon as a satisfactory volume reduction is achieved, the maintenance phase of the lymphedema starts.
N AI
The maintenance phase
A full range of solutions in MAINTENANCE phase of lymphedema treatment
by THERAFIRM®
MADE-TO-MEASURE PATIENT
MADE-TO-MEASURE PATIENT
MADE-TO-MEASURE PATIENT
MADE-TO-MEASURE PATIENT
Worn daily during rest and nighttime, Mobiderm light compression garments offer an easy to use and comfortable alternative to self-bandage that mobilizes edema and optimizes treatment efficiency.(1) The maintenance phase also includes manual lymphatic drainage at a lesser frequency, as well as the learning of self-massaging and self-bandaging as needed. Lastly, it requires the practice of an adapted physical activity, skin cares and regular medical monitoring.
CON T
N AI
CONTAIN
DAYTIME COMPRESSION
AIN & M NT O O
LIZE BI
C
Worn daily from waking up to bedtime, daytime compression garments ensure both: • compression aimed at easing the circulation of the lymph to the heart, thus preventing the formation of edema.
• containment preventing the edema from recovering more than a certain percentage of volume, irrespective of its intrinsic expansion force.
SEVERE LYMPHEDEMA Stage III: Non regular extremity shape Skin folds Fibrotic consistency >40% volume excess
(1) Mestre – Interest of an auto-adjustable night-time compression sleeve (MOBIDERM Autofit) in maintenance phase of upper extremity lymphedema: the MARILYN pilot RCT Support Care Cancer (25:2455-2462) – 2017 – Page 4
11
Breast Area Soft Interior Seams
Adjustable Straps
Prevents skin irritations for patient compliance
Find the best personal fit with wide padded straps for your comfort
High Lateral Design Provides good coverage and added support for affected areas
INTIMATE BRA
Front Zippers with End Covers
Wide Band
Easy to put on and take off with covers to protect skin on each end
Prevents the bra from flipping up during wear
Description The Mobiderm® Intimate Bra provides strong compression and integrates removable and discreet foam compression pads to create high and low pressure differentials on the affected regions, in result, softening tissue and improving lymph drainage. Moreover, this controlled compression solution helps minimize scar tissue and the development of hematomas.
AIN & M NT O O
LIZE BI
C
LYMPHEDEMA PRODUCTS
Colored Hooks
Integrated Pockets
Come in a darker color than the bra to make it easier to see where the bra clasps together
For inserting the breast form of your choice and included Small Block Breast Pads
For which patients Mobiderm Intimate Bra is intended for patients with breast related edema or lymphedema.
Characteristics
Zipper Liner
Interior Back Pockets
Interior Side Pockets
Manufacturing Type: Off-The-Shelf Compression Values: 5 - 10 mmHg
1. Band Size
Colors: Nude
Measure the circumference just under the breast for band size
Composition Bra: Nylon, Elastane, Polyester, Polyurethane Pad: Polyester, Nylon, Acrylic glue, Polyethylene foam
Accessory
2.Cup Size
Learn more about the Mobiderm ® Intimate Bra
Measure the circumference of the fullest part of the breast for cup size
HCPCS: A6528
Description: Gradient compression garment, bra, for nighttime use, each
*Rounding may apply to inch measurements
Order extra pre-made pads! • 2 Mobiderm Small Block Breast Pads included • Fits into the integrated pockets • Provides discreet low profile therapy
X
Y
Z
Item Number
Size
X
Y
Z
T57135120199970
XS
260 mm
155 mm
100 mm
T57135120299970
S
285 mm
160 mm
100 mm
T57135120399970
M
310 mm
165 mm
105 mm
T57135120499970
L
335 mm
170 mm
110 mm
T57135120599970
XL
360 mm
180 mm
120 mm
Suggested HCPCS: A6609, A6593, or A6519 *The pre-made Mobiderm Small Block Breast Pads accommodate all cup sizes.
Additional Mobiderm® Mobilizing Pads available in Big and Small Block (sold separately) to cut and use for different desired shapes or sizes. See page 9 for product sizes and reference numbers.
13
13
LYMPHEDEMA PRODUCTS
C
AIN & M NT O O
LIZE BI
Pelvic and Genital Area Clinical study
INTIMATE SHORTS
Soft fabric(2)(3) for more comfort
Patent deposit on the model, with sober colors: black and blue
Adaptable to most morphologies(3): 6 sizes for women and 6 sizes for men
Description
Flexible and thin: Due to the physical properties of the materials, their location and their assembly according to the body areas (3)
Compression and mobilization shorts Treatment of pelvic and genital lymphedema
For which patients Mobiderm® Intimate Shorts is intended for patients with: • Pelvic and/or genital edema • Mild to severe lymphedema • Stable or progressive edema • Regular or irregular morphology
Is used as underwear
- Targeted compression and retention (15 - 20 mmHg) in the pelvic area, genitals, buttocks and thighs*. - Decreasing compression upwards and downwards the pelvis.* - Compatible with compression stockings.*
A complete solution: shorts + pad • 89% of patients think that this device provides a differentiating solution compared to what exists on the market(1)
Can be worn during the day as well as at night
• 83% of patients think that this device is better than existing products(1) (aesthetics, thickness, ability to movement, comfort, daily use).
Characteristics Manufacturing Type: Off-the-Shelf Colors : Black and Navy Blue
Possibility to insert the pad inside the shorts or remove it according to the patient's needs.
Compression Values: Black Fabric Zone: 15-20mmHg on the pelvic, genital and buttocks areas Blue Fabric Zone: 5-10mmHg on the lateral side and mid-thigh areas
Circumference
cK Around buttocks
Composition
cG Thigh (at widest
• Compression Shorts: Polyamide, Elastane, Polyester • Mobiderm mobilizing genital pad small blocks: Polyester, Polyamide, Acrylic Glue, Polyethylene Foam
point for left and right)
Accessory M en
DISCRETION(1)
COMFORT(1)
View product videos here!
Size
cK (in cm)
cG (in cm)
Women’s Item Numbers
Men’s Item Numbers
1
88–94
45–54
37360120109899
37370120109899
2
95–101
48–58
37360120209899
37370120209899
3
102–108
51–62
37360120309899
37370120309899
4
109–115
54–66
37360120409899
37370120409899
5
116–122
57–69
37360120509899
37370120509899
6
123–129
60–72
37360120609899
37370120609899
HCPCS: A6570
Women
Product thinness(1)
Description: Gradient compression garment, genital region, each
Order extra pre-made pads! Product Style
Product Code
HCPCS
Men's Genital Pad
37375029900399
A6609, A6593, or A6519*
Women's Genital Pad
37365029900399
A6609, A6593, or A6519*
The pre-made Genital Pads are one size fits most and come in Small Block only. * The Suggested HCPCS varies based on usage with bandaging (A6609), daytime garments (A6593), or nighttime garments (A6519)
• 1 Mobiderm Small Block Genital Pad included • Fits into the integrated pockets • Provides discreet low profile therapy
K = 272cm
K = 288cm L = 248cm
Conseils
Patented
device
(4)
d’entretien
Additional Mobiderm® Mobilizing Pads available in Big and Small Block (sold separately) to cut and use for different desired shapes or sizes. See page 9 for product sizes and reference numbers.
(1) O LYMPY study : Exploratory study to assess the clinical benefits of wearing the MOBIDERM Intimate Short in patients with pelvic and/or genital lymphedema. - 2021 - 32 patients - n° ID-RCB: 2020-A00247-32;primary objective: assessment of the effect of the MOBIDERM Intimate short, after 12 weeks, on an overall impression of change in their quality of life in relation to PL/GL. S. Mestre. New perspectives in genital lymphedema management. 46th European Society of Lymphology Congress – June 16-17-18 2022. Assisi Italy (2) CC1508 – Rationnel de formulation – Janvier 2022 (Formulation plan) (3) CC1508 - Panty Mobiderm - Plan de validation (2019) (Validation Plan) (4) Patent issued or filed in the following countries: China, EPE (European Patent Device), France, French Polynesia, Japan, South Korea, USA *Refer to the Instructions For Use
15
CON T N AI
Arms and Hands
AIN & M NT O O
LIZE BI
C
LYMPHEDEMA PRODUCTS Conseils
Patented
device
Patented
STANDARD
technology
AIN & M NT O O
LIZE BI
C
d’entretien
Standard products
Faster* availability
cG
Standard products
l
Faster* availability
Description
cE
cC
The standard Arm Sleeve, Mitten, and Glove are designed to mobilize edematous or indurated subcutaneous tissues. They are intended for the treatment of lymphedema in maintenance phase for day at rest and night to maintain the volume reduction.
cC: Wrist circumference cE: Elbow circumference cG: Arm circumference
37300220100232
37300220100233
37300240100232
37300240100233
37300220200232
37300220200233
37300240200232
37300240200233
37300220300232
37300220300233
37300240300232
37300240300233
37300220400232
37300220400233
37300240400232
37300240400233
37300220500232
37300220500233
37300240500232
37300240500233
l: Length from wrist to axilla
For which patients standard garments are recommended for patients presenting: • Mild to moderate lymphedema • Regular extremity shape • Stable lymphedema volume
37310120100299 37310120200299 37310120300299
Characteristics
37310120400299
Manufacturing Type: Off-The-Shelf
37310120500299
Composition : • Outer layer: polyamide, elastane • Armsleeve inner layer: adhesive non-woven, polyurethane foam (15 x 15 mm blocks) • Mitten and glove inner layer: adhesive nonwoven, polyethylene foam (5 x 5 mm blocks)
37310120600299
(1)
cA: Hand circumference (head of metacarpal bones) cC: Wrist circumference
Color: Beige
Scan the QR code to download your form
37320120100201
37320120100202
37320120200201
37320120200202
37320120300201
37320120300202
37320120400201
37320120400202
37320120500201
37320120500202
37320120600201
37320120600202
cA: Hand circumference (head of metacarpal bones) cC: Wrist circumference
*Compared to Made-to-Measure patient devices (1) Please refer to the Instructions for Use of the product for the full list of components.
17
AIN & M NT O O
LIZE BI
C
LYMPHEDEMA PRODUCTS
Conseils
Patented
device
d’entretien
Patented
technology
Standard products Standard adjustable mobilizing garments Faster* availability
Characteristics Manufacturing Type: Off-The-Shelf
Standard products
Faster* availability
Composition(1): • Outer layer: polyester, polyamide, elastane • Inner layer along the leg/arm: adhesive non-woven, polyurethane foam (15 x 15 mm blocks) • Inner layer foot/hand level: adhesive non-woven, polyethylene foam (5 x 5 mm blocks)
Description
Color: Beige
The garments are designed to mobilize edematous or indurated subcutaneous tissues. They are intended for the treatment of lymphedema in maintenance phase for day at rest and night to maintain the volume reduction. The standard, self-adjustable garment adapts to most of patient’s individual body shape and evolution overtime. They are available in multiple models: • For upper extremity: armsleeve with mitten. • For lower extremity: below-knee or thigh-high.
For which patients garments are recommended for patients presenting: • Mild to moderate lymphedema • Regular or non-regular extremity shape • Stable or fluctuating edema
(1) Please refer to the Instructions for Use of the product for the full list of components * Compared to Made-to-Measure patient devices
19
Several tightening notches
device
•a djustment marks: precise and repeatable application, control of the edema volume variation
Standard products
Faster* availability
Faster* availability
Self-gripping fasteners • easy and quick set up(2)
Scan the QR code to download your form
d’e
Patented
technology
Several tightening notches
Standard products
Con
Patented
•a daptation to most of patient’s individual extremity shape
technology
Stan
Fast
• adaptation to most of patient’s individual extremity shape • adjustment marks: precise and repeatable application, control of the edema volume variation
Standard p
Faster* av
Semi open garment easy to put on, easy to take off(2)
or view measurement forms on pages 30-33.
Sleeve with attached retractable mitten
Semi-open garment
Self-gripping fasteners
•e asy to put on, easy to take off(2)
• easy and quick set up(2)
• helps limiting the risk of edema migration
Double row of fasteners
• the hand can be freed for usual tasks
• wide adaptation range • allows right or left leg use
Size
cA (in cm)
cC (in cm)
cD (in cm)
cG (in cm)
Reference normal l = 40 - 45 cm
17 - 21 17 - 21 18 - 22 18 - 22 19 - 23 20 - 24
15 - 19 16 - 20 17 - 21 17 - 21 18 - 22 19 - 23
22 - 28 24 - 30 26 - 32 28 - 34 30 - 36 31 - 37
25 - 32 29 - 36 33 - 40 37 - 44 41 - 48 45 - 52
37330620100261 37330620200261 37330620300261 37330620400261 37330620500261 37330620600261
37330620100271 37330620200271 37330620300271 37330620400271 37330620500271 37330620600271
Sizes Below Knee - Reference (right/left)
37330620100262 37330620200262 37330620300262 37330620400262 37330620500262 37330620600262
37330620100272 37330620200272 37330620300272 37330620400272 37330620500272 37330620600272
l AD: Floor-to-knee height
(measurement taken below the bend of the knee, back side) l AG: Floor-to-thigh height (measurement at the gluteal fold) cB: Ankle circumference (at the narrowest point) cC: Calf circumference (at the widest point) cD: Below knee circumference (on the head of the fibula) cG: Thigh circumference (at the widest point)
Left Arm Sleeve 1 2 3 4 5
17 - 21 17 - 21 18 - 22 18 - 22 19 - 23
15 - 19 16 - 20 17 - 21 17 - 21 18 - 22
22 - 28 24 - 30 26 - 32 28 - 34 30 - 36
25 - 32 29 - 36 33 - 40 37 - 44 41 - 48
6
20 - 24
19 - 23
31 - 37
45 - 52
HCPCS A6520 (Hand Portion)
+
A6522 (Arm Portion)
(1) Patent issued or filed in the following countries: Algeria, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Morocco, Italy, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, United-Kingdom, USA (2) M estre – Interest of an auto-adjustable night-time compression sleeve (MOBIDERM Autofit) in maintenance phase of upper extremity lymphedema: the MARILYN pilot RCT – Support Care Cancer (25:2455-2462) – 2017 – Page 6
• limits slippage when walking
p.36/37
Reference long l = 45 - 50 cm
Right Arm Sleeve 1 2 3 4 5 6
Anti-slip sole
Clinical study
Sizes
cA: Hand circumference cC: Wrist circumference cD: Forearm circumference (at the widest point) cG: Axillary arm circumference
LIZE BI
d’entretien
(1)
Patented
l CG: Length from wrist to axillary
AIN & M NT O O
Conseils
Patented
device
Lower Extremity
Upper Extremity
C
LYMPHEDEMA PRODUCTS
cB cC Size (in cm) (in cm)
Short Size l D = 38 - 40 cm
Normal
l D = 40 - 42 cm
Long
l D = 42 - 44 cm
Xtra long
l D = 44 - 46 cm
1
37340520100231 37340520100232 37340520100233 37340520100234
2
37340520200231 37340520200232 37340520200233 37340520200234
3
37340520300231 37340520300232 37340520300233 37340520300234
4
37340520400231 37340520400232 37340520400233 37340520400234
Size
Short l G = 67 - 72 cm
Thigh High - Reference (right/left) Normal
l G = 72 - 77 cm
Long
l G = 77 - 82 cm
Xtra long
l G = 82 - 87 cm
Below Knee cD (in cm)
Thigh High cG (in cm)
1
37350520100231 37350520100232 37350520100233 37350520100234
2
37350520200231 37350520200232 37350520200233 37350520200234
3
37350520300231 37350520300232 37350520300233 37350520300234
4
37350520400231 37350520400232 37350520400233 37350520400234
1
16 - 24 24 - 35
25 - 36
46 - 57
2
20 - 28 32 - 43
32 - 43
53 - 65
3
24 - 32 40 - 51
39 - 50
61 - 72
4
28 - 36 48 - 59
46 - 57
68 - 80
Style
HCPCS
Below Knee
A6524
Thigh High
A6526
21
LYMPHEDEMA PRODUCTS
CON T N AI
Control Pressure Adjuster
Patented integrated system ensures precise 20-40mmHg Conseils Patented pressure every time.* d’entretien device
AIN & M NT O O
LIZE BI
C
(1)
Patented
technology
Standard products
Faster* availability
Description ▶ How to use the pressure adjuster?
BIFLEX Self-Adjust is a modular compression wrap system designed for effective, personalized care. Its cushioned open-cell foam absorbs and evenly distribute pressure, while wicking moisture away from the skin. Its low stretch material and overlapping straps** mimic bandaging. This wrap adjusts easily for a tailored fit—no compression guesswork required.
Standard products
The adjuster comes with three levels of pressure: Faster* availability L low (light blue line), M medium (blue lines) and H high (dark blue lines). Pressure is reached by pulling on the strap which slides the adjuster until the outside of the loop is over the desired level of pressure.
For which patients
If necessary, the segment pressure can be modified by adjusting the loops from bottom to top.
BIFLEX Self-Adjust garments are recommended for patients with: • Lymphedema • Edema • Lipedema • Chronic Venous Insufficiency (C3 to C6)
Characteristics Manufacturing Type: Off-The-Shelf Composition: Calf, Thigh & Arm: • Wrap: Polyamide, Elastane, Polyurethane, Polyester • Indicators: Polyamide, Polyurethane Hand, Knee & Foot: • Wrap: Polyamide, Polyurethane, Polyester Protective Liner: • Socks: Polyamide, Elastane
Cushioned Open Cell Foam Comfortable, breathable open-cell foam facilitates moisture transfer from the skin. ***
No Gap Strapping System Built-in 50% overlapping straps designed to mimic bandaging application (1).
Color: Beige
Easy Built-in Donning Aid Simplifies donning and doffing by keeping the garment in place during strap application (2). Fewer straps also make for a simpler application.
Scan the QR code to learn more! 1 Calf and Thigh styles only 2 Calf, Thigh and Arm styles only
23
LYMPHEDEMA PRODUCTS
CON T
AIN & M NT O O
LIZE BI
C
Upper Extremity
N AI
Lower Extremity
cC
(in cm)
15-19
15-20
18150120100299
19-24
17-21
18150120200299
24-29
18-23
18150120300299
Foot
Knee
Calf
Thigh
Circumference cA: Hand (head of metacarpal bones) cC: Wrist
Circumference cC: Wrist cD: Forearm (widest part of forearm) cG: Axillary arm (widest part of the axillary arm) Length l CG: Wrist to axillary arm
Item: 18305029900299
l EG
cG
cE
Product Style
HCPCS
Hand
A6584
Arm
A6588
l BD
cD cC cB
Circumference cG: Thigh (at the widest point) cE: Above the knee cD: Below knee (on the head of the fibula) cC: Calf (at the widest point) cB: Ankle (at the narrowest point) cH: Instep Length l AY: Heel to end of foot l BD: Ankle to knee height (ankle to just below bend of knee) l EG: Above knee to thigh height (just above knee to gluteal fold)
Product Style
HCPCS
Foot
A6587
Calf
A6583
Knee
A6584
Thigh
A6585
Protective Liner - Below Knee
A6593
cH
l AY
25
Lower Leg and Foot
CON T N AI
EASE ADJUST BY THERAFIRM® INELASTIC BELOW KNEE COMPRESSION WRAP
• Made with premium grade materials for maximum durability • Anatomical design contours to the calf for a better fit • Seamless straps reduce pressure points
Description
• Inner sleeve allows for easy application by supporting the wrap while donning and adjusting straps
Adjustable gradient inelastic compression wrap for venous and lymphatic disease. Two patented Core-Spun compressive liner socks included.
For which patients Ease Lymphedema products are intended for patients with:
AIN & M NT O O
LIZE BI
Inelastic materials offer a high working pressure during the day and a low resting pressure with strong containment at night.
INNER SLEEVE Supports easy donning
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LYMPHEDEMA PRODUCTS
• A pair of 10-15mmHg Core-Spun by Therafirm® Socks provide compression and added comfort in the feet and legs
STRONG HOLD Durable strength to withstand garment life
• Venous disease • Lymphatic disease • Wound care needs
How to Measure
Characteristics
1. On the affected leg, measure the circumference of the patient’s ankle at the narrowest point, directly above the ankle bone.
Manufacturing Type: Off-The-Shelf Compression values: • 30 - 50mmHg* in the wrap • 10 - 15mmHg* liner socks
2. Measure the circumference of the calf at the widest point. 3. Measure the circumference under the patient’s knee, just below the knee bend.
Colors : Black
4. Measure the length from the floor to the knee bend (in a straight line).
Size
Ankle
Calf
Under Knee
Small
6.5–9.5" (16–24cm)
9.5–14" (24–35cm)
10–14" (25–36cm)
Medium
8–11″ (20–28cm)
12.5–17″ (32–43cm)
12.5–17″ (32–43cm)
Large
9.5–12.5″ (24–32cm)
16–20″ (40–51cm)
15.5–19.5″ (39–50cm)
X-Large
11–14″ (28–36cm)
19–23″ (48–59cm)
18–22.5″ (46–57cm)
Regular Length: Less than 14″ (36cm)
Tall Length: More than 14″ (36cm)
Ankle, calf, and length are required for proper fit. Sizes based on average. If any measurement is between sizes, select the larger size.
Ease Adjust Wrap Length
Regular
Tall
Size
Item Code
Small Medium Large X-Large Small Medium Large X-Large
68615 68625 68635 68645 68715 68725 68735 68745
*Designed to provide 30-50 mmHg pressure based on wearer needs. Contraindications: Compression products should not be worn and are contraindicated if you have any of the following conditions: arterial insufficiency or degeneration, acute DVT (deep vein thrombosis), untreated congestive heart failure, untreated cancer, untreated infection, absent or severely impaired sensation, allergy to materials, severe or moderate peripheral arterial disease, severe cognitive impairment.
27
LYMPHEDEMA PRODUCTS
CON T N AI
Arms and Hands
Description Ease by Therafirm® Lymphedema Arm Sleeves, Gauntlets, and Gloves are designed with true gradient compression for management and prevention of lymphedema, swelling and discomfort.
• Gradient compression is greatest at the wrist and gradually decreases toward the upper arm
C
Lab-tested true gradient compression gradually decreases upward to promote blood flow. Ultra-stretchy circular knit yarns and seamless engineering offer superior comfort and all-day wear Moisture wicking COOLMAX® fibers provide a comfortable coolness.
• Specialized knit pattern at the inside of elbow bend to help sleeve stay in place and prevent bunching • Features a 1.5” soft, silicone-dotted band to prevent rolling and provide superior comfort for all-day wear • Soft, comfortable non-restrictive wrist 20 – 30mmHg* Arm Sleeves
30 – 40mmHg* Arm Sleeves
Size
Black
Sand
Size
Black
Sand
Ease Lymphedema products are intended for patients with: • Mild to moderate edema • Mild lymphedema
Small
63015
63210
Small
63315
63310
Small Long
63215
63410
Small Long
63415
63410
Medium
63025
63220
Medium
63325
63320
Medium Long
63225
63420
Medium Long
63425
63420
Characteristics
Large
63035
63230
Large
63335
63330
Large Long
63235
63430
Large Long
63435
63430
X-Large
63045
63240
X-Large
63345
63340
X-Large Long
63245
63440
X-Large Long
63445
63440
For which patients
Manufacturing Type: Off-The-Shelf
AIN & M NT O O
LIZE BI
EASE BY THERAFIRM® LYMPHEDEMA GARMENTS
ARM SLEEVES
Colors : Black and Sand Compression values: • 20 - 30 mmHg* Arm Sleeve, Gauntlet, and Gloves • 30 - 40 mmHg* Arm Sleeve and Gauntlet
GAUNTLETS • Gradient compression gradually decreases toward the wrist • Soft, comfortable non-restrictive wrist
Arm Sleeve Size Chart Size
Wrist
Elbow
Axilla
20 – 30mmHg* Gauntlets
30 – 40mmHg* Gauntlets
Size
Black
Sand
Size
Black
Sand
Small
63715
63710
Small
63815
63810
Medium
63725
63720
Medium
63825
63820
Large
63735
63730
Large
63835
63830
X-Large
63745
63740
X-Large
63845
63840
Small
5.5"–6.5" (14–16.5cm)
7.5"–9" (19–23cm)
8.5"–11.5" (21.5–29cm)
Medium
6.25"–7.25" (16–18.5cm)
9"–10.5" (23–26.5cm)
11"–14" (28–35.5cm)
Large
7"–8" (18–20cm)
10.5"–12.25" (26.5–31cm)
13.5"–16.5" (34–42cm)
GLOVES
X-Large
7.75"–9" (19.5–23cm)
12.25–13.75" (31–35cm)
16"–19" (40.5–48cm)
• Gradient compression gradually decreases toward the wrist
Regular: 16" or less (41cm)
Long: over 16" (41cm)
Gauntlets + Gloves Size Chart Size
Palm Girth
Wrist Girth
• Seamless, compressive fingers • Soft, comfortable non-restrictive wrist 20 – 30mmHg* Gloves Size
Black
Sand
Small
63915
63910
63925
63920 63930 63940
Small
6.75"–7.5" (17–19cm)
5.5"–6.5" (14–16.5cm)
Medium Large
63935
Medium
7.5"–8.25" (19–21cm)
6.25"–7.25" (16–18.5cm)
X-Large
63945
Large
8.25"–9" (21–23cm)
7"–8" (18–20cm)
X-Large
9"–9.75" (23–25cm)
7.75–9" (19.5–23cm)
*The mean compression for an average ankle size. Contraindications: Severe arterial insufficiency, cutaneous infections, acute dermatitis, wet dermatosis, uncontrolled congestive heart failure, skin irritations, allergies to dyes. COOLMAX® is a registered trademark of The LYCRA Company.
29
C
AIN & M NT O O
Fitting Instructions
LIZE BI
LYMPHEDEMA PRODUCTS
Measurement Tips A Few Essential Reminders
garments can be worn directly on the skin or with a cotton layer in between in case of sensitive skin. STANDARD • Turn the garment over onto itself 1 • Slide the garment along the extremity to the desired position 2 • Massage the extremity to ensure an even distribution of foam blocks 3 • For Mitten and Glove - Make sure the foam blocks are positioned on top of the hand • For Mitten and Glove - If combined with an armsleeve, position it over the armsleeve • For Mitten - The garment is bilateral, simply flip it inside out for opposite hand.
• Open all hook-and-loop fasteners 1 • Slide the garment along the extremity to the desired position 2 • Close the hook-and-loop fasteners by starting with the distal extremity and moving up 3 • Proceed in several steps until you reach the setting recommended by your healthcare professional (+/++/++/++++++) • Massage the extremity to ensure an even distribution of foam blocks 4
• Measurements must be taken by a healthcare professional or fitter trained to the specificities of garment measurements for the delivery of our devices. • Proper adjustment of the garment on the patient will depend on the transmission of correct measurements.
1
2
• Measurements are preferably made in the morning or after manual lymphatic drainage and at the end of the intensive treatment in case of first use of the device.
3
General Protocol
1
3
2
4
1 – Select the measurement form corresponding to the desired range and type of garment. 2 – Read the whole form. 3 – Complete the header information. 4 – Select the desired model, draw it on the form and cross out useless measures. 5 – Select the desired options. 6 – Draw all anatomical markers on the patient based on the measurement form guidelines. 7 – Measure circumferences at these various markers. 8 – Measure heights associated with the markers.
Take the time to take those measurements and do not hesitate to attach photographs or additional measures to your request.
Care Instructions It is recommended to wash your ALL GARMENTS
garment daily (or after each use).
• Machine wash at wool cycle or cold temperature. • Use a washing product without softener. Do not use detergents, fabric softeners or aggressive products (products containing chlorine). • Place the garment in a wash bag to make sure other garments (particularly those with touch fasteners or zips) do not damage it. • Dry well away from any direct heat source (radiator, sun, etc.). • Do not tumble-dry. • Do not iron.
• Measurement forms • Dermatological felt-tip pen, or kohl pencil to point the markers • Measuring tape (for arm/leg) • "Lasso" tape (for fingers/toes) • Flexible ruler • Wipes
Measurement Sheets To help healthcare professionals prescribe and dispense products, Thuasne provides measurement forms for compression and support hosiery and garments and made-to-measure orthotics.
When not used, the garment should be kept flat, with the selfgripping fasteners closed. If it must be folded, position the hooks pointing outward.
Discover all available video tutorials presenting instructions on our Thuasne YouTube channel!
Tools Required
fitting
31
LYMPHEDEMA PRODUCTS
WINGS FOR YOUR HEALTH THERAFIRM - THUASNE 120 Osage Ave. Kansas City, KS 66105 United States Phone: 1-800-821-3094 Fax: 1-913-281-5455 Email: cs@knitrite.com Therafirm® is a brand of Thuasne, LLC.
Biflex - Indications: Venous insufficiency, simple and complicated varicose veins, reduction of venous and post-traumatic edema, dermatitis/lipodermatosclerosis, varicose ulcers, deep vein thrombosis (prevention and confirmed accident), post-thrombotic syndrome, following sclerotherapy, treatment of lymphedema. Contraindications: PAD (peripheral arterial disease), skin wounds, abscess, infected skin conditions, extra-anatomic bypass, uncontrolled heart failure. BiflexIdeal® - Indications: Treatment of lymphedema, simple and complicated varicose veins, following sclerotherapy, following surgery, reduction of post-traumatic edema, varicose ulcers. Contraindication: Do not apply directly to an open wound. Biplast - Indications: Traumatology (joint or muscle compression sprain, dislocation, tendinitis), phlebology (reduction and stabilization of edema), lymphology. Contraindication: Do not apply the product in direct contact with broken skin. Mobiderm Pads & Bandages Indications: Acute or chronic edema management (e.g. lymphedema). Contraindications: skin infection of the extremity or acute inflammation, known allergy to components used, septic thrombosis, severe peripheral neuropathy of the extremity. Lower extremity - PAD (peripheral arterial disease) of lower extremitys with ABPI < 0.6, congestive heart failure, advanced diabetic microangiopathy, phlegmasia cerulea dolens, extra-anatomic bypass. Upper extremity - pathology of brachial plexus, vasculitis of the extremities. Mobiderm Autofit, Standard - Indication: Maintenance of volume reduction in lymphedema. Contraindications: Skin infection of the extremity or acute inflammation, known allergy to components used, septic thrombosis, severe peripheral neuropathy of the extremity. Lower extremity - PAD (peripheral arterial disease) of lower extremitys with ABPI < 0.6, congestive heart failure, advanced diabetic microangiopathy, phlegmasia cerulea dolens, extra-anatomic bypass. Upper extremity - pathology of brachial plexus, vasculitis of the extremities. Mobiderm Intimate Bra - Indications: Acute or chronic edemas of the breast and/or the chest wall, post-operative edemas or edemas after radio therapy (only on intact skin), chronic infiltration after reconstruction, remaining chronic chest wall edemas. Contraindications: Allergic or inflammatory skin changes (e.g. swelling, reddening of the body area to be cared for). Use only on intact skin, not on infected or acutely inflammatory skin. Please consult with the treating physician regarding the indication and wearing mode of this orthopedic aid. Mobiderm Intimate Shorts – Indication: Treatment of pelvic and genital lymphedema. Contraindications: Skin infections on the pelvis or legs ; Pregnant women (from the first month) ; Known allergies to any of the components ; Lower extremity peripheral arterial disease (PAD) with ankle brachial index (ABI) < 0.6 ; Decompensated heart failure ;Septic thrombosis of the proximal veins ; Phlegmasia cerulea dolens (painful blue edema with arterial compression) in the thighs ; Posthectomy (circumcision) within the past three months ; Female patient with marked localized edema of the labia minora only. Foam bandage, Protective underwrap - Indications: Protection of cutaneous surfaces to cover. Foam bandages and Varico products contain latex. Ease by Therafirm® Lymphedema garments -Contraindications: Severe arterial insufficiency, cutaneous infections, acute dermatitis, wet dermatosis, uncontrolled congestive heart failure, skin irritations, allergies to dyes. Ease Adjust by Therafirm® Wrap - Contraindications: Severe arterial insufficiency, cutaneous infections, acute dermatitis, wet dermatosis, uncontrolled congestive heart failure, skin irritations, allergies to dyes.
THUASNE 120 rue Marius Aufan 92300 Levallois-Perret Cedex - France
, , Biplast, BIFLEXIDEAL, bandages accessories,
Therafirm 120 Osage Avenue Kansas City, KS 66105
,
Ease Lymphedema, Ease Adjust Wrap
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. All the medical devices mentioned on this document are CE marked according to the Regulation 2017/745 on medical devices, unless specifically identified as “NOT CE MARKED”. Products mentioned in this document are CE class I devices. Please contact Thuasne should you need any additional information on devices classification. Please read carefully the instructions for use, indications and contraindications of the product. We reserve the r ight to modify our products as shown and described in this catalogue, without previous notice. Non-contractual photographs. Please check the availability of products according to the countries. Last revision date: (2023-03). Ref: 0116 092 164 – 11 - 2210309. Photos: Studio Caterin
5PLYMCAT 2606