2024 Lymphology Catalog

Page 1


LYMPHEDEMA PRODUCT CATALOG

Dear Customers,

We are pleased to share our lymphedema solutions, including new Mobiderm Intimate Shorts and made-to-measure garments 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.

Be sure to inquire about the possibility of lymphedema treatment products being covered by the Lymphedema Treatment Act.

175 years of the Thuasne 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.

Today, Thuasne is...

2,400 collaborators worldwide

50% of revenue earned internationally

14 industrial sites in Europe and the United States

30 to 40 new products offered each year

9.3 million miles of knitted textiles

Revenue of 270 million dollars in 2021 Commercial presence in 85 countries

22,000 professional clients

5 international patents registered each year

3,500 miles of material produced per year

Take care wisely with Thuasne solutions

In everything we do, we believe in challenging the status quo. We believe that we must think differently.

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).

• 40 years of medical and technical expertise in compression devices

• 2 made-to-measure production sites

• 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

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.

Origin of Lymphedema

PRIMARY LYMPHEDEMA

There are 2 types of lymphedema:

Related to a constitutional defect of the lymphatic system. Congenital or familial, it mainly affects the lower extremitys. In the majority of cases, it is necessary to initiate management of the condition from childhood. Primary lymphedema can also start in young adults.

new cases in the under-20 age group every year(1) 20 YEARS In 80% of the cases it affects the lower extremitys (2)

11.5/1 million

2/3 of the cases affect women(1)

SECONDARY LYMPHEDEMA

Primary Lymphedema prevalence is estimated at 1 per 6 000(3) individuals

It may turn out:

Prematurely Before the age of 35 for 65 to 80% of people(4)

Tardily

After the age of 35 for 10% of people(4)

Results from a damage of the lymphatic system associated with a trauma, a disease like cancer and its treatment (lymph node dissection, radiotherapy…) or a contamination. Secondary lymphedema concerns:

of patients treated for breast cancer(4) of patients treated for gynaecologic or prostatic cancer(5) Between 20 & 40%

Breast cancer and its treatment is the leading cause of upper extremity lymphedema

1/5 women suffers from secondary lymphedema of the upper extremity after breast cancer(6)

(1) Les lymphoedèmes du membre inférieur - Dr Marlène Coupé - Mars 2020 - Pages 22-23

(2) Lymphoedème primaire – Orphanet - Mars 2020 - Page 2

It concerns:

15 to 28% of patients who have had axillary curettage(7)

2.5 to 6.9% of patients after the sentinel node technique(7)

(3) Orphanet, webportal on rare diseases and orphan drugs, www.orpha.net : Primary limphedema – November 2007 – Document prepared in collaboration with: Dr Stephane Vignes /Consultation of the reference center for rare vascular diseases, Cognacq-Jay Hospital, Paris.

(4) Disipio T et al. Lancet Oncol 2013; 14: 500 Incidence of unilateral arm Lymphedema after breast cancer: a systematic review and meta-analysis

(5) Beesley V et al. Cancer 2007 Jun 15;109(12):2607-14. Lymphedema after gynecological cancer treatment : prevalence, correlates, and supportive care needs. Rasmusson E. et al. Radiat Oncol. 2013 Nov 19;8:271 Low rate of lymphedema after extended pelvic lymphadenectomy followed by pelvic irradiation of node-positive prostate cancer.

(6) Lymphoedèmes secondaires du membre supérieur après cancer du sein - S. Alran, A. Arnaud, J.-C. Biffaud, J.-C. Ferrandez, P. Heudel – 13 March 2016

(7) Prise en charge du lymphoedème secondaire du membre supérieur après un cancer du sein – March 2014

The median of occurrence is 2 years after surgery or radiotherapy(7)

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

This chronic disease therefore requires continuous management, which can be split into two essential and complementary phases:

The REDUCTION phase that will follow one another depending on the evolution of the lymphedema.

The MAINTENANCE phase

Medical compression is one of the key elements of the treatment

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:

• Manual lymphatic drainage (MLD), trained physiotherapist, to stimulate and facilitate the circulation of the lymph by promoting the unblocking of the lymph nodes.

• Reducing and draining bandages of multi-component bandages which can be adapted to the volume and repositioned at will.

• Coached physical activity lymph circulation, regain mobility and flexibility.

• Skin care

This phase may vary from one to several weeks, depending on the severity of the lymphedema, and can be renewed later.

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)

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, the Mobiderm technology mobilizes edematous or indurated subcutaneous tissue.

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)

The Technology

is a medical device made up of foam blocks encased between two non-woven bandages.

The Technology can be used under a reducing bandage (in its bandage or pad forms), or incorporated into mobilizing garments.

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)

Compressive layer

Epidermis

Dermis

Lymphatic capillaries

EFFECTIVE

• Rapid volume reduction of the edema(2).

PRACTICAL

• Light and comfortable, it enables the patient to keep their freedom of movement(3)

COMFORTABLE

• Ability of the product to contour the extremity provides an adapted anatomical fit

Pads

Dimensions Designation

25 cm x 25 cm

25 cm x 1 m

20 cm x 1 m

Dimensions

10 cm x 3 m

Small blocks 5 mm x 5 mm

Big blocks 15 mm x 15 mm

Bandages

Designation

Small blocks 5 mm x 5 mm

Big blocks 15 mm x 15 mm

Reference

371001 02502501

371001 03310001

371001 03310002

Reference

372001 01030001

372001 01030002

Kits

KIT n°1

Reduction kit for the treatment of upper extremity edema

Content

• 1 Biflex 16+ bandage, 8 cm x 5 m

• 1 Biplast bandage, 3 cm x 2.5 m

• 1 Short-stretch cotton bandage, 11 cm x 4 m

• 2 Mobiderm bandages, 10 cm x 3 m

• 1 Biflexideal bandage, 10 cm x 5 m

KIT n°2

Reference

370090 29999901

Reduction kit for the treatment of lower extremity edema

Content

• 1 Biflex 16+ bandage, 10 cm x 3 m

• 1 Biflex 16+ bandage, 10 cm x 5 m

• 1 Biplast bandage, 3 cm x 2.5 m

• 2 Short-stretch cotton bandages, 11 cm x 4 m

• 3 Mobiderm bandages, 10 cm x 3 m

• 2 Biflexideal bandages, 10 cm x 5 m

2 SIZES OF BLOCKS

SMALL BLOCKS

• More effective in highly induced areas

• Better adapted to small anatomies (pediatric patients, hands/foot, breast…)

Reference

370090 29999902

BIG BLOCKS

• Better adapted along the extremity

The maintenance phase

As soon as a satisfactory volume reduction is achieved, the maintenance phase of the lymphedema starts.

This phase is conducted first with elastic compression garments which will be renewed regularly under the supervision of a healthcare professional.

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.

CONTAIN AND MOBILIZE REST AND NIGHTTIME COMPRESSION

Worn daily during rest and nighttime, Mobiderm light compression devices 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.

CONTAIN DAYTIME COMPRESSION

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.

How to choose the right solution?

A full range of solutions in MAINTENANCE phase of lymphedema treatment

SEVERE LYMPHEDEMA

Stage III:

Non regular extremity shape

Skin folds

Fibrotic consistency

>40% volume excess

MODERATE LYMPHEDEMA

Stage II & Late II: Regular extremity shape

Liquid consistency 20-40% volume excess

MILD LYMPHEDEMA

Stage 0 & I : Regular extremity shape

Liquid consistency No skin folds

<20% volume excess

INTIMATE SHORTS

Description

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

Characteristics

Colors : black and navy blue

Compression values:

• 15 - 20 mmHg

• 5 - 10 mmHg at the abdominal and mid-thigh area

Composition

• Compression shorts: polyamide, elastane, polyester

• Mobiderm mobilizing genital pad small blocks: polyester, polyamide, acrylic glue, polyethylene foam

Sizes

cK (cm) cG (cm)

1 88 - 94 45 - 54 37370120109899

2 95 - 101 48 - 58 37370120209899

3 102 - 108 51 - 62 37370120309899

4 109 - 115 54 - 66 37370120409899

5 116 - 122 57 - 69 37370120509899

6 123 - 129 60 - 72 37370120609899 cK (cm) cG (cm)

1 88 - 94 45 - 54 37360120109899

2 95 - 101 48 - 58 37360120209899

3 102 - 108 51 - 62 37360120309899

4 109 - 115 54 - 66 37360120409899

5 116 - 122 57 - 69 37360120509899

6 123 - 129 60 - 72 37360120609899

Pelvic and Genital Area

COMFORT(1)

Soft fabric(2)(3) for more comfort

Adaptable to most morphologies(3):

6 sizes for women and 6 sizes for men

Flexible and thin: due to the physical properties of the materials, their location and their assembly according to the body areas (3)

Men Women

A complete solution: shorts + pad

• 89% of patients think that this device provides a differentiating solution compared to what exists on the market(1)

• 83% of patients think that this device is better than existing products(1) (aesthetics, thickness, ability to movement, comfort, daily use).

Possibility to insert the pad inside the shorts or remove it according to the patient's needs.

DISCRETION(1)

Patent deposit on the model, with sober colors: black and blue

Can be worn during the day as well as at night Is used as underwear

Product thinness(1)

- 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.*

View product videos here!

(1) OLYMPY 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° IDRCB: 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

countries: China, EPE (European Patent Device), France, French Polynesia, Japan, South Korea, USA

Patented device

STANDARD GARMENTS

Conseils d’entretien

Standard products

Standard products Faster* availability Faster* availability

Description

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.

For which patients

standard garments are recommended for patients presenting:

• Mild to moderate lymphedema

• Regular extremity shape

• Stable lymphedema volume

Characteristics

Composition(1):

• 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)

Color: beige

Arms and Hands

Armsleeve

cm) Reference (right / left)

l = 40 - 45 cm Long l = 45 - 50 cm

1 14 - 16 22 - 25 25 - 29 373002 20100232 373002 20100233

1+ 24 - 27 28 - 32 373002 40100232 373002 40100233

2 16 - 18 25 - 28 29 - 33 373002 20200232 373002 20200233

2+ 27 - 30 31 - 35 373002 40200232 373002 40200233

3 18 - 20 28 - 31 32 - 36 373002 20300232 373002 20300233

3+ 30 - 33 35 - 39 373002 40300232 373002 40300233

4 20 - 22 31 - 34 35 - 39 373002 20400232 373002 20400233

4+ 33 - 36 38 - 42 373002 40400232 373002 40400233

5 22 - 24 34 - 37 38 - 42 373002 20500232 373002 20500233

5+ 36 - 39 41 - 45 373002 40500232 373002 40500233 Glove

Mitten

right/left 1 14 - 16 15 - 17 373101 20100299 2 16 - 18 17 - 19 373101 20200299 3 17 - 19 19 - 21 373101 20300299 4 19 - 21 21 - 23 373101 20400299 5 20 - 22 23 - 25

373101 20500299 6 21 - 23 25 - 27 373101 20600299

Hand circumference (head of metacarpal bones)

Wrist circumference

Elbow circumference

Axillary arm circumference

14 - 16

-

20100201 373201 20100202 2 16 - 18 17 - 19 373201 20200201 373201 20200202 3 17 - 19 19 - 21 373201 20300201 373201 20300202 4 19 - 21 21 - 23 373201 20400201 373201 20400202

20500202

20600202

Patented device

Conseils d’entretien

Standard products

Standard adjustable mobilizing garments

Faster* availability

Standard products

Faster* availability

Description

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 evolutive edema

Mechanism of action

The garments incorporate technology that is made up of foam blocks encased between two non-woven bandages. Due to the difference in pressure it creates between the support area of the blocks and their surrounding area, it helps stimulate the flow of lymphatic fluid and optimizes drainage efficacy(1)(3)

Compressive layer

Epidermis

Dermis

Lymphatic capillaries

Characteristics

Composition(2):

• 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)

Color: beige

Scan the QR code to download your form or view measurement forms on pages 30-33.

Sleeve with attached retractable mitten

• helps limiting the risk of edema migration

• the hand can be freed for usual tasks

Sizes

Right Arm Sleeve

l: Length from wrist to axillary

cA: Hand circumference

cC: Wrist circumference

cD: Forearm circumference (at the widest point)

cG: Axillary arm circumference

Upper Extremity

Several tightening notches

• adaptation to most of patient’s individual extremity shape

• adjustment marks: precise and repeatable application, control of the edema volume variation

Self-gripping fasteners

• easy and quick set up(2)

Semi-open garment

• easy to put on, easy to take off(2)

(1)

Lower Extremity

Several tightening notches

• adaptation to most of patient’s individual extremity shape

• adjustment marks: precise and repeatable application, control of the edema volume variation

Self-gripping fasteners

• easy and quick set up(2)

Double row of fasteners

• wide adaptation range

• allows right or left leg use

limits slippage when walking

Sizes

lD: Floor-to-knee height (measurement taken below the bend of the knee, back side)

lG: 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) A

1

2

MADE-TO-MEASURE PATIENT GARMENTS

Description

The made-to-measure patient garments are designed to mobilize edematous or indurated subcutaneous tissues.

They are intended for the treatment of lymphedema in maintenance phase for day and night to maintain the volume reduction.

For which patients

made-to-measure patient garments are recommended for patients presenting:

• Moderate to severe lymphedema

• Non-regular extremity shape

• Out of standard sizes

• Stable lymphedema volume

Characteristics

Composition(1):

• Outer layer: polyamide, elastane

• Inner layer: adhesive non-woven, polyurethane foam (15 x 15 mm blocks) or polyethylene foam (5 x 5 mm blocks)

Color: beige

patient devices require the involvment of a trained healthcare professional.

Lower Extremity Upper Extremity

Arm Sleeve with mitten and without thumb

Arm Sleeve with mitten and thumb

EASE BY THERAFIRM®

LYMPHEDEMA GARMENTS

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.

For which patients

Ease Lymphedema products are intended for patients with:

• Mild to moderate edema

• Mild lymphedema

Characteristics

Colors : black and sand

Compression values:

• 20 - 30 mmHg* Arm Sleeve, Gauntlet, and Gloves

• 30 - 40 mmHg* Arm Sleeve and Gauntlet

Arm Sleeve Size Chart

Size Wrist Elbow Axilla

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)

X-Large 7.75"–9" (19.5–23cm) 12.25–13.75" (31–35cm) 16"–19" (40.5–48cm)

Regular: 16" or less (41cm) Long: over 16" (41cm)

Gauntlets + Gloves Size Chart

Size Palm Girth Wrist Girth

Small 6.75"–7.5" (17–19cm) 5.5"–6.5" (14–16.5cm)

Medium 7.5"–8.25" (19–21cm) 6.25"–7.25" (16–18.5cm)

Large 8.25"–9" (21–23cm) 7"–8" (18–20cm)

X-Large 9"–9.75" (23–25cm) 7.75–9" (19.5–23cm)

Arms and Hands

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.

ARM SLEEVES

•Gradient compression is greatest at the wrist and gradually decreases toward the upper arm

• 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

Size Black Sand

Small 63015 63210

Small Long 63215 63410

Medium 63025 63220

Medium Long 63225 63420

Large 63035 63230

Large Long 63235 63430

X-Large 63045 63240

X-Large Long 63245 63440

GAUNTLETS

• Gradient compression gradually decreases toward the wrist

30 – 40mmHg* Arm Sleeves

Size Black Sand

Small 63315 63310

Small Long 63415 63410

Medium 63325 63320

Medium Long 63425 63420

Large 63335 63330

Large Long 63435 63430

X-Large 63345 63340

X-Large Long 63445 63440

• Soft, comfortable non-restrictive wrist

20 – 30mmHg* Gauntlets

Size Black Sand

Small 63715 63710

Medium 63725 63720

Large 63735 63730

X-Large 63745 63740

GLOVES

• Gradient compression gradually decreases toward the wrist

• Seamless, compressive fingers

• Soft, comfortable non-restrictive wrist

30 – 40mmHg* Gauntlets

Size Black Sand

Small 63815 63810

Medium 63825 63820

Large 63835 63830

X-Large 63845 63840

20 – 30mmHg* Gloves

Size Black Sand

Small 63915 63910

Medium 63925 63920

Large 63935 63930

X-Large 63945 63940

EASE ADJUST BY THERAFIRM®

INELASTIC BELOW KNEE COMPRESSION WRAP

Description

Adjustable gradient inelastic compression wrap for venous and lymphatic disease. Liner socks included.

For which patients

Ease Lymphedema products are intended for patients with:

• Venous disease

• Lymphatic disease

• Wound care needs

Characteristics

Colors : black

Compression values:

• 30 - 50mmHg* in the wrap

• 10 - 15mmHg* liner socks

Legs and Feet

Inelastic materials offer a high working pressure during the day and a low resting pressure with strong containment at night.

• Made with premium grade materials for maximum durability

• Anatomical design contours to the calf for a better fit

• Seamless straps reduce pressure points

• Inner sleeve allows for easy application by supporting the wrap while donning and adjusting straps

• A pair of 10-15mmHg Core-Spun by Therafirm® Socks provide compression and added comfort in the feet and legs

How to Measure

1. On the affected leg, measure the circumference of the patient’s ankle at the narrowest point, directly above the ankle bone.

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.

4. Measure the length from the floor to the knee bend (in a straight line).

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

Size Black

Small Regular 68615

Small Tall 68715

Medium Regular 68625

Medium Tall 68725

Large Regular 68635

Large Tall 68735

X-Large Regular 68645

X-Large Tall 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.

Fitting Instructions

garments can be worn directly on the skin or with a cotton layer in between in case of sensitive skin.

MADE-TO-MEASURE PATIENT OR 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

• 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

It is recommended to wash your garment daily (or after each use).

ALL GARMENTS

• 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.

When not used, the garment should be kept flat, with the selfgripping fasteners closed. If it must be folded, position the hooks pointing outward.

Measurement Tips

A Few Essential Reminders

• Measurements must be taken by a healthcare professional trained in made-to-measure lymphology devices and to the specificities of Thuasne measurements for the delivery of our devices.

• Proper adjustment of the garment on the patient will depend on the transmission of correct measurements.

• 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.

General Protocol

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.

Tools Required

• 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.

Discover all available video tutorials presenting fitting instructions on our Thuasne YouTube channel!

Customer Name:

Customer Account:

Patient Name:

Gender : M F

Patient’s height:

Models LEFT RIGHT

Below-knee

Thigh-high

Foam options

All small blocks

All big blocks

Big blocks on the leg and small blocks on the feet (by default)

Proximal options

Anti-slip with silicone dots 3 cm

Velcro opening (Maximum 1/3 of the height)

Distal options

Purchase Order #: Ships To: Therapist Patient

Shipping Address:

Email: Phone: Please complete and submit to

City: State: Zip Code:

If possible, please enclose photos of the limb to be fitted. Please draw in the contours of the garment on the diagram and cross out unnecessary measures.

MADE–TO–MEASURE UPPER EXTREMITY SLEEVE

Patient Name:

Gender : M F

Patient’s height:

Please

Customer Name:

Customer Account:

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RIGHT ARM LEFT ARM

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Models

Arm Sleeve (big blocks only)

Arm Sleeve with mitten with thumb (big blocks on the arm and small blocks on the hand)

Arm Sleeve with mitten without thumb (big blocks on the arm and small blocks on the hand)

Sleeve options

Anti-slip with silicone dots 3cm Velcro opening

If possible, please enclose photos of the limb to be fitted. Please draw in the contours of the garment on the diagram and cross out unnecessary measures.

Positioning the measuring tape to measure heights

Length in cm

Circumference in cm

Please draw desired location on the diagram and indicate desired length in the special instructions area below.

Special Instructions

Please draw the desired rise at the shoulder on the diagram and indicate the length from the top of cG to the shoulder (maximum 4cm).

☐ Left Leg ☐ Right Leg

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MOBIDERM Lower Extremity

☐ Auto Fit

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ORDER QUOTATION RENEWAL

Patient’s First Name:

Patient’s Last Name: Gender: M F Pediatric

Patient Height: Case No. for renewal: 1st Treatment Date: Quantity:

Left Arm Right Arm

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MOBIDERM Autofit

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Note: We recommend going up one size to accommodate for upper arm coverage

Left Hand ☐ Right Hand

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MOBIDERM

Mitten

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Patient’s Last Name:

Gender: M F Pediatric

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Mitten Glove

Exploratory study to evaluate the clinical benefits of wearing the INTIMATE SHORTS in patients with pelvic and/or genital lymphedema: OLYMPY(1)study

Introduction

Pelvic or genital lymphedema (PL/GL) is a chronic and challenging condition, that causes important discomfort and swelling altogether with emotional and social problems, leading to impaired quality of life for affected patients and families. In the absence of standard of care regarding treatment or evaluation criteria, it was decided to set up a non-comparative clinical exploratory study to assess the performance and safety profile of a new compression device in patients presenting PL/GL.

Objective

Evaluation by the patient of the effect of the MOBIDERM Intimate Shorts after 12 weeks of wear, on a global impression of change in their quality of life in relation to Pelvic / Genital Lymphedema.

RESULTS RELATED TO THE SEVERITY OF LYMPHEDEMA(1)

Significant overall decrease in lymphedema severity (p=0.0446).

Lymphedema severity (heaviness, tension, swelling, urinary disorders) decreased in 45% of patients. Percentage of patients with mild lymphedema increased by a factor of 3.

RESULTS RELATED TO THE SUPPLENESS OF THE SKIN(1)

Significant improvement in skin suppleness (p=0.009).

2/3 of the patients have an increase in the suppleness of their skin.

The percentage of patients with indurated skin is divided by 7 after 3 months.

RESULTS RELATED TO THE EVOLUTION OF PERIMETRY (only for men)(1)

Significant decrease in one of the 3 measurements: Middle of the scrotum.

Neck circumference of the scrotum.

Length of the scrotum.

Overall, 2/3 of men show a decrease in scrotal perimetry.

RESULTS RELATED TO CHANGES IN QUALITY OF LIFE

61% of patients show a better global quality of life after 3 months.

On a scale of 0 to 100, the score improved by +9.5 points after 3 months.

(1)

RESULTS RELATED TO PATIENTS' SATISFACTION

• Ease of use for 3/4 of the patients

• Comfortable for 93% of patients

• Pressure of the device is tolerated for 92% of patients

• 93% of patients like the aesthetics

CONCLUSION(1)

Overall improvement in about 80% of patients according to the patient and physician’s opinion (moderate to strong in 2 out of 3 patients according to the patient).

Improvement of the patient's quality of life:

• Significant decrease in discomfort and swelling related to genital lymphedema

• 61% of patients show a better general quality of life after 3 months (EQ5D daily activities, mobility, anxiety)

• Improvement in the psychosocial domain according to the Lymphedema specific LyQLI questionnaire

Decrease in the severity of genital lymphedema:

• Significant decrease in the GLS score described in the literature to qualify the severity of lymphedema

• 45% of patients show a decrease in lymphedema severity

• Perimetric reduction of the scrotum in 2 out of 3 men

• Significant improvement in skin suppleness

Compliance with the device

• 69% of patients showed good compliance with the INTIMATE SHORTS during the day and 45% at night (slightly lower compliance for the Pad)

Satisfaction with the device

• 86% of patients are globally satisfied with the product

• 96% of patients want to continue wearing the INTIMATE SHORTS after the study

• Differentiating solution for 77% of healthcare professionals

Interest of an auto-adjustable nighttime compression sleeve ( ) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT

S.Mestre1,2 & C. Calais1 & G. Gaillard1 & M.Nou1 & M.Pasqualini3 & C.Ben Amor3 & I.Quere1,2,4

DOI 10.1007/s00520-017-3652-5

Introduction

Rebound effect of lymphedema volume is observed after Decongestive Lymphedema Therapy (DLT) in patients with Breast Cancer Secondary Lymphedema (BCSL). Successful outcomes of lymphedema long term treatments are depending on patient compliance.

Objective

The primary objective of this pilot prospective open-label randomized study was to assess the benefit of a new auto-adjustable nighttime arm sleeve ( ) on lymphedema volume during the maintenance phase after the intensive phase. Secondary objectives were to assess compliance and satisfaction of patients equipped with Mobiderm Autofit device.

COMPLIANCE RESULTS SATISFACTION RESULTS*:

How would you rate ? Easy/Very easy to put on

Useful self adjustement

Easy/Very

Comfortable

85% of patients

of patients

•Mean age: 67

•Mean time since diagnosis of breast cancer: 11

•Mean time since lymphedema diagnosis: 7

•Lymphedema Stages: II, III

Absolute mean volume excess variations (cm3)

• Vol excess variation D0/D30 (%): 1.80 in Gp I vs 3.20 in Gp II (NS)

• At day 30.85% of DLT effect is maintained in Gp I vs 54% in Gp II

Group I

Group II

Volume variation in High Responders (HR)patients (cm3)

• benefit is more pronounced among High Responders DLT (Loss of 35% during DLT - POLIT study, JMV 2014)

HR Gp I

HR Gp II

CONCLUSION

Results of primary criterion suggest that tends to limit rebound effect of lymphedema after DLT, especially in patients who were strongly responsive to DLT. Between D30 and D90, study period in which all 40 patients were fitted with the study medical device, a lymphedema volume stabilizing effect is observed.

Results of secondary criteria show that displays favorable characteristics that increase patient's independence from specialized medical staff or relatives while keeping high level of patient's compliance in maintenance phase.

Night sleeve, on top of daily compression, could offer benefit to patients during maintenance phase of lymphedema treatment and enhances patient’s autonomy.

(1) Service de médecine interne et vasculaire, Hôpital St-Eloi, Montpellier, France

(2) EA2992 Caractéristiques féminines des dysfonctions des interfaces vasculaires, Universités de Montpellier-Nîmes, France

(3) Thuasne, Levallois-Perret, France

(4) Centre d’Investigation Clinique, INSERM CIC 1001, Montpellier, France

* Patient questionnaire submitted to each enrolled patient at the end of the study

WINGS FOR YOUR HEALTH

THERAFIRM - THUASNE

120 Osage Ave.

Kansas City, KS 66105

United States

Phone: 1-800-821-3094

Fax: 1-800-462-4707

Email: cs@knitrite.com

Therafirm® is a brand of Knit–Rite, 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 & BandagesIndications: 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 and Made-to-Measure garmentsIndication: 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

Therafirm 120 Osage Avenue Kansas City, KS 66105

, , Biplast, BIFLEXIDEAL, , bandages accessories, 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

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