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VenaPure™

www.DJOGlobal.euCONFIDENTIAL – FOR INTERNAL USE ONLY

Designed With VTE Prevention in Mind

VenaPure™Anti-Embolism Stockings


VenaPure™



Section 1: Introduction and Business Objectives

Section 2: International Market Analysis

Section 3: Product Positioning

Section 4: Product Information

Section 5: Ordering Information

Section 6: Sizing & Ordering Information

Section 7: Fitting Information

Section 8: Competitive Overview

Section 9: Sales Support Materials

Section 10: Frequently Asked Questions

Section 11: Glossary of Terms

Section 12: Clinical References

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Venous thromboembolism, (VTE) encompasses both deep vein thrombosis (DVT) and pulmonary embolism (PE) and

remains a common condition that is associated with significant morbidity and mortality and can prove costly to

healthcare providers and sufferers. Approximately 30% of patients die within the first month following an embolism

event. According to the VITAE group (VTE Impact Assessment Group in Europe), 1 the number of VTE-related

deaths in Europe is estimated at more than half a million. When you consider that we are well informed about traffic

accidents, cancers and AIDS, then the lack of awareness on VTE is very surprising.

Section 1: Introduction and Business Objectives

DVT is a blood clot, also called thrombus or thrombosis, which forms in a vein deep in the body. DVT may become

fatal if the clot breaks loose from the wall of the vein and travels to the lungs, blocking the pulmonary artery. When

this happens it is called a Pulmonary Embolism (PE) and it blocks the blood flow from the heart, becoming life

threatening.

1.1 How Do Blood Clots Form?

Virchow was an eminent German pathologist in the 1850s. He developed a “Triad of Factors”, which he showed to

predispose a patient to VTE. If at least 2 of these factors exist, then the risk of VTE is elevated. The Triad of Factors

are: Venous Stasis; Vessel Wall Damage and Blood Coagulation.

543,454

5,860

86,831

63,636

53,599

VTE Related Deaths

AIDS

Breast Cancer

Prostate Cancer

Transport Accidents

Figure 1. Annual Deaths (European Statistics1)

Factors Important in

Thrombogenesis

Blood Coagulation• Induced by patients underlying disease• Inherited/acquired coagulation disorders• Clinical intervention

Venous Stasis• Reduced due to pressure/trauma

• Heart failure• Obesity• Pregnancy• Immobility• Incompetent valves

Vessel Wall Damage• Accidental trauma• Surgical trauma especially

in orthopaedics• Immobility• Incompetent valves• Pregnancy• Age

Figure 2. Virchow’s Triad of Factors

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Virchow’s Triad has accurately predicted the occurrence of VTE and in turn has led to many advances in both the

prevention and treatment of this condition. The continuing challenge for all healthcare professionals, is that it is still

primarily asymptomatic and the first symptom may be death, as seen by a PE!

Hospitalisation is one of the largest risk factors for incurring a VTE; surgical patients have a 20-fold higher risk for

DVT than the general population. Within surgical patients, orthopaedic patients are one of the highest risk categories

and DVT can occur in as many as 40% of postoperative total knee replacement patients.

As both DVT and PE are asymptomatic and therefore difficult to detect, physicians try to prevent their development

by mechanical means (anti-embolism stockings, intermittent pneumatic compression, foot impulse devices) or

pharmacological means (warfarin, heparins). Without this preventive treatment, as many as 80% of orthopaedic

surgical patients are at risk of developing DVT and 10% to 20% of these will develop PE. However, despite these

preventive measures, VTE still remains the most common cause for emergency readmission and death following joint

replacement.

What has been proven in a number of clinical studies is that one mode of prophylaxis alone cannot effectively prevent

VTE, a multi-modal approach is by the far the most effective method of prophylaxis.

1.2 DJO Continuum of Care in Preventing VTE

With the launch of the new VenaPure anti-embolism stocking , DJO Global is in a superb position to offer a complete

Continuum of Care in preventing venous thromboembolism .

VenaPure will be launched as the anti-embolism stocking Designed with VTE Prevention in Mind. It has been

developed to build upon the current high market expectations for the product and has embodied all the critical

product features essential to clinically prevent VTE.

Virchow’s TriadVessel Wall Damage

• VenaPure™

Venous Stasis• VenaPure™• VenaFlow® Elite

Blood Coagulation• VenaFlow® Elite• Pharmacologicals (anticoagulants)

VenaPure will be launched as the anti-embolism stocking Designed with VTE Prevention in Mind.Our aim is to become the # 2 in this market within 5 years.

Figure 3. Where DJO Products can Prevent VTE

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Prevalence

The American College of Chest Physicians (ACCP) has for long been seen as the leading group in advocating

guidelines for the prevention of VTE.

Table 1: The Latest ACCP Guidelines on VTE Prevention (2008)

In the UK, a recent report stated that an estimated 25,000 people die from preventable hospital –acquired VTE every

year. 2

Australia recently reported, following a VTE Working Party report that VTE leads to more than 30,000 hospitalisations

and an estimated 5,000 patient deaths per year. Australia is now setting up an online VTE Prevention Resource

Centre , designed to introduce VTE prevention protocols throughout both the private and public hospital sector. 4

In a recent epidemiological study in Korea 5, VTE was shown to be increasing year on year. Whilst still not as high as

in the Western population, the annual incidence was shown to be 13.8 per 100,000 individuals.

In a 2002 study from Singapore 6, the acute DVT frequency was recorded at 15.8 per 10,000 admissions, higher

than previously realised.

In the PROVE registry, 7 differences were illustrated in VTE cases between the Asian and European/Australian

patient population: Asian patients were younger and typically had more proximal DVT. This could be due to the low

awareness of VTE prevention and therefore the lack of prophylactic measures being used.

VTE Impact 1,2, 8

► In the UK it is estimated to cost £640 million per year in the UK to manage VTE-related conditions.

► At least one third of DVT patients will suffer from post-thrombotic syndrome (PTS)

► 4-5% of patients will suffer pulmonary hypertension (PH) following a PE

► Approximately 10% of hospital deaths are from PE

► In a Spanish registry, RIETE, results showed only 23% of patients presenting with VTE received prophylaxis

► In the same Spanish registry, there were bleeding complications in 60% of patients on oral anticoagulants and

40% of those on LMWH

Section 2: International Market Analysis

Patient Group DVT Prevalence %

Medical Patients 10-20

General Surgery 15-40

Hip or Knee Arthroplasty 40-60

Major Trauma 40-80

Spinal Care Injury 60-80

Critical Care Patients 10-80

The data in Table 1 shows the prevalence of VTE amongst patients not receiving prophylaxis. 3 It demonstrates the

relevant risk of certain surgical procedures to patients without using any prophylaxis.

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Target Market for DJO International

• DJO has a well established expertise in Orthopaedics, in both the prevention and treatment of sports

related injuries. This is the core competence of the company and one which can be built upon to provide

the platform for our introduction into VTE prevention. See Figure 4.

• In many markets, we have some primary contact with hospitals and especially orthopaedic surgeons.

Our target market, initially, must be these contacts since use of both the new VenaPure anti-embolism

stocking and VenaFlow Elite, the intermittent pneumatic device will be driven from here.

International Orthopaedic Market (General)

• Market Size

• European orthopaedic procedures are expected to be over 1 million in 2010 9

• This patient group is at highest risk of VTE due to surgical manipulation of limbs and subsequent trauma to major vessels

• Possible trends over the next 3-5 years will lead to an overall increase in orthopaedic procedures due to:

1. Younger first time patients

2. Increased life span

3. Increasing minimally invasive procedures

4. More advanced technologies

5. Increasing number of revisions following earlier procedures

General Surgery

Plastics

Trauma

Orthopaedic Procedures

Leverage our expertise in Orthopaedics

2011 / 2012

Figure 4. Expanding Focus from Core Customers to potentially New Customers

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International Market Drivers

There are a number of threats to the VTE market, including price erosion, commoditisation and cheap local products, however there are also a tremendous amount of opportunities as the awareness of the problems surrounding VTE become known.

Important Assumptions about the Market

Over the next 3-5 years, we can estimate that :

1. Market in VTE prevention products could grow 9%, driven by growing awareness2. Influx of home grown product will gain 5% market share (primarily Asian markets)3. Customers will not accept price increases, especially in anti-embolism stockings4. New entrants, especially in the IPC arena5. Impact of e-commerce will alter business6. Healthcare cost pressure - move to private insurance7. General economic recovery worldwide will be slow

DJO

Healthcare Provision

Pharmaceutical Companies

Patients/Charities/Advocacy

Groups

Stocking Manufacturers

Technological:• New oral anticoagulatnts• Improved IPC technology• Multimodal approach to VTE prevention clinically proven

Legal – Regulatory:• Increase in litigation• Patient advocacy• Infection control issues reducing re-use of products

Socio-Political:• Increased awareness of VTE overall• Need for patient risk assessment• Hospital VTE protocols• Clinical guidelines• Improved clinician training

Demographics:• Ageing population• Rise in obesity• Sedentary lifestyles•

Economic:• Price erosion• Healthcare budgets• Stocking re-use• Reduced number of elective surgical procedures

Figure 5. Macro Influences on the VTE Market

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International Competitor Landscape & Market Share Data

The EMEA Market for Anti-Embolism Stockings estimated at $64m in 2010 (internal data).

Frost & Sullivan in 2008 have tried to evaluate the market for static compression, under which anti-

embolism stockings fall. They have estimated the European market value for 2010 at $619.5m – this

includes however bandages, compression hosiery (Classes I-IV) and anti-embolism stockings.

Covidien (Kendall) was first to market with a clinically proven anti-embolism stocking, T.E.D ., first launched

in 1952. This product has changed very little since it’s launch. Much of the current market has been developed

and led by Covidien, using their dedicated and clinically trained sales force to gain access to the Vascular

world and subsequently to all areas of hospital care. They were previously the only company able to “bundle”

their AES with IPC, (SCD Express and 700) , which has given them strength in purchasing and credibility with

healthcare professionals.

Medi has had much success in many markets building on their superiority in compression hosiery and has

gained considerable market share with their AES. Whilst they do not have IPC, their high quality compression

line is considered one of the worldwide market leaders.

BSN has included Comprinet into the large portfolio of products brought about by the partnership of

Beiersdorf and Smith & Nephew. Comprinet is also sold in certain countries internationally under the Jobst

family.

Others make up the smaller portion of sales and include many local only brands, however in some countries

like the UK, these brands still make up a considerable portion of the business. Brands like Carolon, Brevet to

name a few.

More information on the products follows in Section 6.

45%

34%

17%

4%

Covidien

Medi

BSN

Others

Figure 6. Pie chart representing the estimated market shares of the key players in the Anti-Embolism Stocking market through EMEA (internal data).

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Key Decision Makers & Influencers - Hospitals

Decisions regarding the purchase of anti-embolism stockings now reside more recently with Purchasing

Departments, however it is important not to underestimate the influence of other healthcare professionals in the

decisions on whether to adopt a new stocking. It is critical to understand who the chief influencers are and what

specific role they play in adopting products.

Decision Maker Important Decision-Making Criteria

Physician (Clinicians/Surgeons/Anaesthetists)

Clinical efficacy and/or clinical referencePatient ComplianceNursing Acceptance

Ability to meet government targets

Nursing Personnel

Clinical efficacyProduct quality

Ease of useTraining & tools to support use

Patient Compliance

Materials/Procurement Management

PricingInventorySupply

Nursing acceptance

Risk/Quality Management/Clinical Directors

DVT ratesCost of treatment vs. prophylaxis

Evidence based practicePatient safety

ReimbursementHospital finances

Table 2. What decisions are most likely to drive key personnel to initiate change

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VenaPure

Value proposition

VenaPure anti-embolism stockings have been Designed With VTE Prevention In Mind. We have been able to use the

years of clinical experience gained in the arena of VTE prophylaxis and combine all the positive attributes of our

competitive products into our product.

Decision Making Criteria/Needs

– Surgeon: Clinical outcomes, patient compliance, nursing acceptance

– Nurse: Ease of use, safety, compliance, clinical outcomes, product support

– Materials/Procurement Managers: Price, contracts, company reputation, supply, nursing acceptance

– Risk/Quality Management: DVT rates, facility reputation/PR, patient safety

Positioning Statements – “Designed with VTE Prevention in Mind”

Surgeon: Can be assured of high quality VenaPure to protect the patient and therefore preserving their

reputation in providing superior clinical outcomes for their patients.

Nurse: Due to excellent manufacturing techniques, VenaPure is easy to use and promotes patient

compliance and is supported by well thought out product material and a well trained company presence.

Materials/Procurement: Can look to the reputation and product portfolio of DJO and Aircast brands to

continually provide high quality, cost effective solutions.

Risk/Quality Management: By working with us, they can help to deliver improvements in VTE

prophylaxis by offering the continuum of care in vascular therapy with the right range of products.

Section 3: Product Positioning

1. We must offer a clinical message, for which we need clinician champions. 2. By offering both VenaPure and VenaFlow Elite, we are demonstrating our commitment to

preventing Vascular Diseases.

For our success, this message needs to extend further than our current customer base.

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Design Philosophy

VenaPure has been designed to show equivalence to the product that is most used internationally for the

prevention of VTE:

o Graduated compression levels distally to proximal to ensure blood is moved

o Circumferential knit to maintain compression levels throughout wear and to minimise vein dilation

o Anatomical shape to ensure patient fit and compliance

Vascular is one of our key opportunities in which DJO Global will invest and we will look for further

improvement and innovation and also invest in clinical research.

Clinical Benefits

Up to now, there have been no clinical trials performed on the VenaPure Anti-Embolism Stocking,

however due to it’s design and features, we are able to demonstrate that:

► Due to the compression profile used, VenaPure can enhance venous flow velocity 15

► By offering thigh length stockings, can effectively reduce the incidence of clots occurring in the femoral vein

► There are reduced DVT rates when combined with chemoprophylaxis 10

► VenaPure reduces venous distension , thereby preventing endothelial damage 11

► Proven to be effective in reducing the risk of DVT as monotherapy, especially in certain high risk patients 12

► Should be used routinely on all patients admitted into hospital 13

► In high risk patients, especially at risk of bleeding, anti-embolism stockings are a safe alternative 14

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5. Pressure Relieving Panel

4. PoplitealBreak

3. InspectionToe

2. Interrupted Silicone Thigh Band

Section 4: Product Information

6. Colour Coded Top and Toe 7. Defined heel

pocket and sizingprint

1. Graduated Compression Profile

4.1: VenaPure Features Overview

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VenaPure Product Features

2) Interrupted Silicone Thigh Band

VenaPure thigh stockings are indicated for the

immobile patient, however it is still very important that

the stockings remain in place. The interrupted silicone

band provides excellent fixation to the skin,

minimising stocking slippage without constricting

compression.

8 mmHg

10 mmHg

8 mmHg

14 mmHg

18 mmHg

1) Compression Profile

VenaPure has been designed according to the Gold Standard, which was researched by Sigel 15

in1975. He found that a graduated compression profile, as below, was most effective in increasing

femoral blood flow, which has a direct impact on preventing venous stasis and therefore minimising the

risk of DVT forming.

VenaPure is tested in our manufacturing site to ensure that this compression profile is met.

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3) Inspection Toe Hole

VenaPure has it’s inspection opening on the top of the

foot, which offers benefits, compared to the

competition in terms of the ease for nursing personnel

to check the condition of the foot and skin. It also

reduces the chance of picking up hospital debris if

ambulatory.

4) Popliteal Break

VenaPure’s thigh length product demonstrates a clear

relief of compression at the popliteal (knee) area. The

compression here is 8mmHg. This is to remove

constriction around the popliteal vein which lies very

close to the surface behind the knee and promotes

free leg movement. The distinctive stitch pattern

change ensures correct positioning.

5) Pressure Relieving Panel

It has been proven in a number of clinical

papers, that the majority of thrombi form in

the valve cusp or wall of the femoral vein.

Therefore it is critical to minimise any

adverse constriction by reducing the

pressure in the inner thigh area where the

femoral vein is located.

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6) Colour Coded Top and Toe

Each stocking has a specific colour thread sewn into

the top (silicone band on thigh or band on knee) and

into the inspection hole on the toe. This is to denote

the specific size of the product and follows industry

specifications.

7) Defined Heel Pocket & Print Logo with Sizing

The heel pocket facilitates correct positioning during

the application. The specially printed logo on the foot

denotes the product name, VenaPure, and the product

size by alpha code: M Regular. This logo will be

retained for the life of the product.

8) Inlay Circumferential Knit

This helps ensure the proper pressure pattern

through the leg and helps to prevent slippage.

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4.2 Range of Styles Available

Knee Range12 sizes available in Regular and Long lengths

Thigh Without Belt Range15 sizes available in Small, Regular and Long lengths

Thigh With Belt Range15 sizes available in Small, Regular and Long lengths

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4.3 Packaging Components

Polybag

Contains 1 pair of stockings.

Dispenser Box

The polybags are contained within a Dispenser Box

(sales unit).

Knee Product – 12 pairs per box

Thigh Product (with and without belt) – 6 pairs per

box

Dispenser Box Labels

The labels on the dispenser box denote the Style

(Knee, Thigh or Thigh with Belt), the Size, the Colour

Coding and the EAN numbers.

Tape Measures

Every dispenser contains the same

number of tape measures as pairs

of stockings, either 6 or 12.

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Section 5: Ordering Information

Unit Quantity Product Description Minimum OrderQuantities

Pair 1 Knee N/A

1 Thigh without belt N/A

1 Thigh with belt N/A

Sales Dispenser 12 pair Knee 72 pair/6 dispenser

6 pair Thigh without belt 36 pair/6 dispenser

6 pair Thigh with belt 36 pair/6 dispenser

Order Guidance

Please bear in mind that the sales unit remains the Sales Dispenser and that the stockings are not to be sold individually in pairs.

The dispensers are shipped in specific containers and we are unable to split them or mix product.

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Section 6: Sizing and Ordering Information

6.1 Size Selection & Measurement

In order to ensure that the stocking fits the patient correctly, it is essential to measure the

patient’s leg and choose the appropriate size.

If measuring for a thigh length product (with or without belt), it is essential to measure:

• The widest circumference of the thigh Figure 7 (1)

• The widest circumference of the calf Figure 7 (2)

• The length of the leg from the buttock fold to the floor Figure 7 (3)

If measuring for a knee length product, it is essential to measure:

• The widest circumference of the calf Figure 7 (2)

• The length of the leg from behind the knee to the floor Figure 7 (3)

An incorrectly fitting stocking will mean:

- The compression profile is incorrect along the leg and therefore will NOT deliver the

required compression to minimise DVT and PE from forming

- The stocking will not fit and will either fall down or will be too tight on the leg, leading to

lack of patient compliance

Figure 7. Important measurements to determine sizing

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6.2 Sizing Information

THIGH WITHOUT BELTThigh Circumference 1

Calf Circumference 2 Toe

Leg Length 3 Top Code Size

<63.5

<30.5<74 401S-2

S74-84 401R-2>84 401L-2

30.5-38<74 401S-3

M74-84 401R-3>84 401L-3

38-44.5<74 401S-4

L74-84 401R-4>84 401L-4

63.5-81.5 44.5-55<74 401S-5

XL74-84 401R-5>84 401L-5

81-91 55-66

<74 401S-6

XXL74-84 401R-6

>84 401L-6

THIGH WITH BELT

Thigh Circumference 1

Calf Circumference 2 Toe

Leg Length 3 Top Code Size

<63.5

<30.5<74 402S-2

S74-84 402R-2>84 402L-2

30.5-38<74 402S-3

M74-84 402R-3>84 402L-3

38-44.5<74 402S-4

L74-84 402R-4>84 402L-4

63.5-81.5 44.5-55<74 402S-5

XL74-84 402R-5>84 402L-5

81-91 55-66<74 402S-6

XXL74-84 402R-6>84 402L-6

KNEECalf Circumference

2 ToeLeg Length

3 Top Code Size

<30.5 <41 400R-2 S>41 400L-2

30.5-38 <43 400R-3 M>43 400L-3

38-44.5 <46 400R-4 L>46 400L-4

44.5-51<46 400R-5 XL>46 400L-5

51-58.4<46 400R-6 XXL>46 400L-6

58.5-66<46 400R-7

XXXL>46 400L-7

Once the measurement has

been taken, the size can be

selected by:

Product code eg 400R-2

Colour identification on the

top of the stocking and the toe

hole eg Yellow toe with Blue

top indicates product reference

400L-2

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Section 7: Fitting Information

How to Apply VenaPure Stockings

a) Insert hand into heel of the stocking with the palm facing upwards.

b) Grab the heel pocket and make a fist with your hand.

c) Roll the stocking inside out over your closed fist, still retaining the heel pocket in your palm.

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d) Withdraw the hand and place the stocking onto the foot with the heel pocket underneath the foot. Carefully work with the patient’s leg and pull the stocking over the foot.

e) Carefully roll the stocking up the leg, working with the patient. Work slowly, smoothing our wrinkles on the way up the leg.

f) The stocking fits correctly when the heel pocket is in the correct location. Do not worry if the foot is rather long. Ensure that the popliteal break is also around the knee. You can tell from the stitch change in the stocking if it is correctly positioned.

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Features VenaPure™ T.E.D.™ Mediven®Thrombexin ®18

Comprinet® Pro

Brevet® tx Preventex®

Manufacturer DJO Aircast Covidien Kendall

Medi BSN Mölnlycke Urgo Medical

Graduated compression profile (mmHg)

18-14-8-10-8 18-14-8-10-8 18 (ankle)- 8 (upper thigh)

18 None specificed

18-6

Popliteal break Yes, noticeable change in knit

Yes, noticeable change in knit

Yes, noticeable change in knit

No Yes Yes, noticeable change in knit

Pressure relieving panel (thigh)

Yes Yes No No No Yes

Inspection toe opening

On top of foot

Underneath foot

Underneath foot On top of foot

Underneathfoot

Underneathfoot

Styles & Sizes:- Knee- Thigh- Thigh with Belt

- 12- 15- 15

- 12- 18- 10

- 6- 9- 4

- 4- 8- 0

-5- 5- 5

- 10- 12- 8

Other -Antibacterial toe-3D fleecy soft heel

Reinforced heel pocket

Mechanical compressionavailable

VenaFlow® Elite: Graduated,Sequential, Rapid inflation

SCD Express™ & SCD 700:Graduated,sequential, circumferential, slow compression

None None None None


This market is becoming a commodity-driven market and less attention is being paid to quality, patient compliance and

clinical efficacy, whilst more attention is being given to price and product availability.

However, since the user is both the patient and the nurse, the features that enhance quality, patient compliance and clinical

efficacy cannot be underestimated.

Below is a selection of the major international competitors:

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8.1. Covidien (Kendall) – US company

T.E.D.™ Anti-Embolism Stockings

This is the first to market anti-embolism stocking with the introduction of the knee in 1952, thigh in 1973

and the thigh with belt in 1975.

T.E.D. Feature Weakness VenaPure Value

Compression Profile TED was designed based on clinical evidence, the Sigel profile is considered to be the Gold Standard in VTE prevention. Measurement for 5 point compression on the Instron machine.

VenaPure was designed to replicate the proven market leader and has used the experience gained with TED to produce a comparable alternative

Inspection Toe Underneath Important to have an inspection toehole, however the underneath position could cause slippage, if patient walks and patient could pick up dirt etc from hospital floor. Not quite so easy to inspect foot.

VenaPure inspection hole on top makes it quick, easy and safe to review patient’s foot. If patient decides to walk, then less chance of damage occurring

Manufacturing Site Europe is currently provided by a UK manufacturing site, which will shut shortly. Manufacturing moves to US globally.

Current supply and quality issues could occur through Europe as the transition to the US takes place

Clinical Expertise TED is the most clinically proven AES on the market, however the majority of these papers are over 10 years old.

By using similar product features and design, VenaPure is able to demonstrate equivalence in terms of clinical efficacy.

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8.2. Medi – German base

Mediven® Thrombexin® 18


Thrombexin Feature Weakness VenaPure Value

Compression Profile Claim to comply to clinically proven profiles of graduated compression from 18-8.

VenaPure was designed to replicate the proven market leader and has used the experience gained with TED to produce a comparable alternative

Inspection Toe Underneath Important to have an inspection toehole, however the underneath position could cause slippage, if patient walks and patient could pick up dirt etc from hospital floor. Not quite so easy to inspect foot.


No Pressure Relieving Panel in thigh

Thrombexin does not have any femoral relief panel, which could lead to excess pressure on the femoral vein.

The pressure relieving panel in VenaPure ensures that there is no undue pressure on the femoral vein (where the majority of fatal PEs arise)

Silicone band There are rectangular colour markings to ensure that the stocking is the correct fit for the patient. Offer only 19 sizes across 3 ranges.

VenaPure offers 42 different sizes across 3 styles to ensure that the correct product is selected to fit the right patient size.

Antibacterial toe There is no clinical proof that this is effective in minimising infections. Question whether the addition of antimicrobial properties makes this a pharmaceutical product.

The inspection toe on the top of the foot allows the nurse to regularly check the condition of the foot and to ensure there is no infection.

3D Colour Coded Heel Introduced a fleecy soft heel toprevent bed sores & colour coded for correct positioning.

VenaPure has a clearly defined reciprocated heel to ensure correct positioning and the toe on the top to allow for easy inspection.

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8.3. BSN – UK base

Comprinet™ Pro


Comprinet Feature Weakness VenaPure Value

Limited range of sizes:4 x Knee8 x Thigh0 x Thigh with belt

The lack of sizes could compromise patient safety and clinical efficacy by not providing the correct fit and compression profile for individual patients.

VenaPure offers 42 different sizes over 3 styles, therefore providing products for the majority of the population. This also means that we can meet the conditions of most tenders, which require a wide range of styles and sizes.


Comprinet does not have any femoral relief panel, which could lead to excess pressure on the femoral vein.


No visible popliteal break There is a risk of excessive pressure on the popliteal vein, which could cause venous damage and restrict blood flow

VenaPure has a clearly defined change in compression profile around the popliteal area, critical to ensure no constriction

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8.4. Urgo Medical – French base

Preventex®

PreventexFeature

Weakness VenaPure Value


Preventex does not have any femoral relief panel, which could lead to excess pressure on the femoral vein.

The pressure relieving panel in VenaPure ensures that thereis no undue pressure on the femoral vein (where the majority of fatal PEs arise)

Inspection Toe Underneath

Important to have an inspection toehole, however the underneath position could cause slippage, if patient walks and patient could pick up dirt etc from hospital floor. Not quite so easy to inspect foot.


8.5. Mölynlcke – Danish base

Brevet® tx

Brevet Feature Weakness VenaPure Value


Brevet does not have any femoral relief panel, which could lead to excess pressure on the femoral vein.


Limited range of sizes – 5 only each style

The lack of sizes could compromise patient safety and clinical efficacy by not providing the correct fit and compression profile for individual patients.

VenaPure offers 42 different sizes over 3 styles, therefore providing products for the majority of the population. This also means that we can meet the conditions of most tenders, which require a wide range of styles and sizes.

Inspection Toe Underneath

Important to have an inspection toe hole, however the underneath position could cause slippage, if patient walks and patient could pick up dirt etc from hospital floor. Not quite so easy to inspect foot.

VenaPure inspectionhole on top makes it quick, easy and safe to review patient’s foot. If patient decides to walk, then less chance of damage occuring

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Section 9: Sales Support Materials

Marketing Collateral Update:

► Launch Binder

► User Guide Ref: 00-2321-EN

► Ward Poster Ref: 00-2327-EN

► Clinical Studies (Available on iDJO)

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Section 10: Frequently Asked Questions

Does VenaPure contain Latex?

No, none of the components of VenaPure contain latex.

Is there any clinical evidence showing that VenaPure is effective in minimising VTE?

VenaPure anti-embolism stockings have been manufactured using the internationally known Gold Standard of the T.E.D. Stockings by Covidien. By manufacturing a stocking that is similar to the TED product, we have aimed to recreate the same proven clinical efficacy that has been successful over many years.We are more than willing to undertake a suitable trial, however would expect to see equivalence to the Gold Standard and not superiority.

Can I buy just a pair of stockings?

No, VenaPure is only available in dispensers of either 12 or 6 pairs, depending on the style.

I don’t have a tape measure, but I am quite sure I know their size.

It is very important to correctly measure each and every patient to ensure that the stocking selected is the correct fit. This is important because:-The compression profiles need to be in the correct places to ensure that there is not undue constriction or too much room.- If the product is too tight or too loose, then it is unlikely that the patient will want to wear the stockings and therefore will not be compliant.

How often can I wash my stockings?

The stockings can be washed up to 30 times, before we can no longer guarantee the stocking characteristics remain. We recommend using a gentle wash no hotter than 70° C. They can be tumble dried on medium heat (max 80°C).We recommend that each patient is provided with 2 pairs of stockings, to ensure continuity of protection.

Can I use these stockings on other patients, once washed?

No, these stockings are single patient use only. We cannot guarantee that all risk of cross-contamination has been eliminated through the recommended washing protocol.

When should I wear VenaPure and for how long?

In order to receive maximum protection, the patient should wear these stockings for as long as they are immobile, especially at night. A patient is mobile, once they start walking normally again for most of the day. You may want to remove the stockings an hour a day, to allow the patient to wash and for the nursing personnel to check the condition of the skin.

Do we have a closed toe AES?

No, we do not currently offer a closed toe anti-embolism stocking, however this is definitely something that we can consider.

Why would I choose thigh with belt?

These are recommended for very thin or obese patients, where the normal range do not fit. The waist band and side panels are designed to prevent slippage.

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Adjuvant► Adding one method to another form of prophylaxis/therapy

Anticoagulant► An anticoagulant is a substance that prevents coagulation; that is, it stops blood from clotting. A group of

pharmaceuticals called anticoagulants can be used in vivo as a medication for thrombotic disorders.

Anti-Embolism Stockings (AES)

► Stockings that have been proven to minimise the occurrence of venous thromboembolism (DVT and PE).

They have a graduated compression profile distally to proximal along the leg.

Chemoprophylaxis► Chemoprophylaxis refers to the administration of a medication for the purpose of preventing disease or infection.

Deep Vein Thrombosis► The formation of a blood clot ("thrombus") in a deep vein.

Intermitted Pneumatic Compression (IPC):► A mechanical method of delivering compression.

Low Molecular Weight Heparin (LMWH):

► A class of medication used as an anticoagulant in diseases that feature thrombosis, as well as for prophylaxis in

situations that lead to a high risk of thrombosis.

Post Thrombotic Syndrome (PTS):

► This is a frequent side effect of DVT and is a chronic and lifetime condition. It can occur in 20-40% of all patients who

experienced a lower limb DVT.

Pulmonary Embolism (PE):

► A blockage of the main artery of the lung or one of its branches by a substance that has travelled from elsewhere in

the body through the bloodstream (embolism).

Pulmonary hypertension:

► Increase in blood pressure in pulmonary artery, vein or capillaries, which can lead to shortness of breath,

dizziness and fainting

Sequential Compression Device (SCD):

► An intermittent pneumatic compression system that includes inflatable compression sleeves to reduce risk of clot

formation, such as deep vein thrombosis, in the legs of hospitalized patients.

Thrombogenesis: ► Creation of a blood clot

Venous thromboembolism (VTE): ► A disease that includes deep vein thrombosis (DVT) and pulmonary embolism (PE).

Section 11: Glossary of Terms

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Section 12: Clinical References

1) Cohen AT et al (2007)

Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb. Haemost. 2007;98:756-764

Description: Epidemiological model constructed to estimate the total burden of VTE throughout Europe. Data was extrapolated from 6 European countries for whole of Europe.

Results: Estimated that more than half a million deaths were attributed to VTE in Europe, more than road traffic accidents, breast cancer, prostate cancer and AIDS together. This does not include the lifelong conditions that DVT cause. This is a preventable condition and demonstrates the need for national guidelines and protocols.

2) House of Commons Select Committee UK (2005)

The prevention of venous thromboembolism in hospitalised patients. London. The Stationery Office.

Description: Committee was presented with data that showed an estimated 25.000 people in the UK die each year from hospital-acquired VTE. This review gave rise to the subsequent clinical review by NICE, with the objective of producing guidelines and protocols for hospitals within England and Wales.

3) Geerts et al. (2008)

Prevention of venous thromboembolism. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) Chest 133/6 June 2008 Supplement

Description: The ACCP have long produced guidelines on the management of VTE prevention and periodically review the results based on new evidence. Each surgical speciality is reviewed and recommendations made according to the clinical evidence available.

4) National Health and Medical Research Council Australia (2011)

Venous thrombosis prevention policy summit May 2010: Summary Report. Melbourne; National Health and Medical Research Council; 2011

Description: Council was set up to introduce best practice guidelines for VTE prevention in Australian hospitals. This is seen as an ongoing process, however the first step has been the introduction of Guidelines for Australian hospitals in how to assess patients and then implement VTE prevention strategies.

5) Jang MJ. et al. (2010)

Incidence of venous thromboembolism in Korea: from Health Insurance Review and Assessment Service Database. Journal of Thrombosis & Haemostasis 2010 10.1111

Description: Epidemiological study on incidence of VTE amongst Koreans, using retrospective patient data. Reviewed data from 2004 to 2008.

Results: Showed an increase in the incidence of VTE over time period, especially showing the growing impact of age and incidence. Whilst there is a lower incidence of VTE amongst this population than seen in Western Europe, it is still significant.

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6) Lee et al. (2002)

Deep Vein Thrombosis is not rare in Asia – The Singapore General Hospital Experience. Ann AcadMed Singapore 2002; 31:761-4

Description: Retrospective study of patients with symptomatic DVT between Jan 1996-Dec 1997.

Results: At a rate of 15.8 per 10,000 population the rate of DVT is higher than previously reported. Demonstrates the need for greater awareness and more clinical studies.

7) Turpie AGG. (2005)

A comparison of patients with DVT in Asia and Europe/Australia: Findings from the PROVE registry. Journal of Thrombosis & Haemostasis 2005; Vol 3, Supp 1:Abstract no. P2238

Description: Multicentre, multinational observational study on Asian/European/Australian patients with symptomatic DVT confirmed by ultrasound.

Results: Asian patients were found to be younger, had more poximal DVT and recieved far less prophylaxis than those in Europe/Australia. Important though is that Asian patients are similarly at risk to VTE as the Western countries.

8) Arcelus J (2003)

The management and outcome of acute venous thromboembolism: A prospective registry including 4011 patients. J Vas Surg 2003; 38:916-22

Description: Spanish multicentre registry of patients with confirmed DVT and/or PE

Results: 4011 patients included; 60% DVT, 23% PE, 17% both; 86% had VTE diagnosed via ultrasonography; 95% of DVT located in the lower extremities. Predominant prescribing of LMWH in both prevention and treatment of DVT. These results are a useful tool for the physician to manage VTE.

9) Millenium European Surgical Procedures MRG 2007

Description: The Millenium Group compile results based upon hospital statistics as well as obtaining confirmation from manufacturing companies. This report reviews all surgical procedures through Europe and tries to identify trends across procedures and markets.

10) Autar R (2009)

A review of the evidence for the efficacy of anti-embolism stockings (AES) in venous thromboembolism (VTE) prevention. Journal of Orthopaedic Nursing 2009;13:41-49

Description: AES have been proven to reduce VTE, both as monotherapy and as an adjuvant and this paper examines the level of clinical evidence that supports these decisions. Despite this evidence, there is still some scepticism amongst clinicians regarding their efficacy, showing that up to 50% of patients are denied protection. Undoubtedly more clinical trials are required to resolve some of the open issues.

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11) Coleridge-Smith PD (1991)

Deep vein thrombosis: effect of graduated compression stockings on distension of the deep veins of the calf. British Journal of Surgery,1991; Vol 78:724-26

Description: Small study to show that during operative procedures, veins distend unless prevented from doing so. 40 patients selected undergoing abdominal & neck surgery. Gastrocnemius vein studied using ultrasound imaging.

Results: Control vs AES group showed post-op vein diameter measurements. In AES group, median diameter fell from 2.6mm to 1.6mm. In control group, median diameter increased from 2.6mm to 2.9mm.

12) Roderick P et al. (2005)

Towards evidence-based guidelines for the prevention of venous thromboembolism: Systematic reviews of mechanical methods, oral anticoagulants, dextran and regional anaesthesia as thromboprophylaxis. Health Technology Assessment 2005;Vol 9; no 49

Description: Review of electronic databases of properly randomised clinical trials into VTE prevention using a mechanical or pharmaceutical means.

Results: Mechanical compression reduced risk of DVT by about 2/3 as monotherapy and ½ as adjuvant.. There is no real difference between the types of mechanic al compression used.

13) NICE Clinical Guideline 92 (2010)

Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. January 2010

Description: Driven by the 2005 Health Select Committee, these guidelines were originally drawn up to cover only surgical patients, they were subsequently revised and reissued in 2010 to include all hospitalised patients. They provide the framework within which each hospital is now expected to work in setting up VTE specialist programmes. AES is recommended for all patients admitted into hospital for a surgical procedure.

14) Nicolaides AN et al. (2006)

Prevention and Treatment of venous thromboembolism. International Consensus Statement. IntAngiology 2006;25:101-161

Description: International and multidisciplinary faculty have created a concise document that examines peer reviewed, fully published papers of randomised trials and observational reviews and categorises the evidence. This is then used to provide guidelines for surgical and medical specialities and for patient conditions in the use and choice of thromboprophylaxis.

15) Sigel B (1975)

Type of compression for reducing venous stasis. Archives of Surgery 1975:110:171-175

Description: Designed to identify optimal compression levels to reduce venous stasis. Measured femoral vein blood flow velocity by Doppler ultrasound in healthy patients in a series of body positions.

Results: Optimal compression should be 18mmHg at ankle and 8mmHg at mid-thigh, which was proven to increase femoral vein average blood flow velocity to 134.8% over baseline.

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