VenaFlow Walk Away From Risk - DJO Globalstorage.djoglobal.eu/.../Marketing...binder_lo_pdf.pdf · The Western European market is estimated to be at $125 million with a 9% CAGR (2005

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VenaFlow® Elite

www.DJOGlobal.euCONFIDENTIAL – FOR INTERNAL USE ONLY

Walk Away From Risk

Section 1: Introduction and Business Objectives

Section 2: International Market Analysis

Section 3: Product Positioning

Section 4: Competitive Matrix

Section 5: Sales Strategy & Overview

Section 6: Sales Support Materials

Section 7: Clinical Research

Section 8: Product Information

Section 9: Sizing, Pricing and Ordering Information

Section 10: Post Launch Dashboard

Section 11: Glossary of Terms

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Much of the data in Western Europe is not available but in the United States, approximately 200,000 deaths occur

annually as a result of deep vein thrombosis (DVT). 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.


So how do blood clots form in the first place? According to Virchow's triad, venous thrombosis occurs via three

mechanisms: decreased blood flow rate, damage to the blood vessel wall and an increased tendency of the blood to

clot (hypercoagulability). These three factors typically pose a risk for surgical patients because they have surgical

trauma, decreased flow rate from not being ambulatory yet and hypercoagulability occurring from the body's own

response to healing. To minimize this risk and prevent DVT, guidelines suggest applying prophylaxis pre-operatively,

intra-operatively and post-operatively for surgery 30-60 minutes or longer.

200,000

14,499

40,200

42,116

Pulmonary Embolism

AIDS

Breast Cancer

Highway Fatalities

Annual Deaths (US Statistics)

Factors Important in

Thrombogenesis

Blood Coagulability• Increase in tissue factor• Presence of activated factors• Decrease in coagulation inhibitors

Venous Stasis• More time for clotting• Small thrombi not washed away• Viscosity increased

Vessel Wall Damage• Accidental trauma• Surgical trauma when the

hip is dislocated

Virchow’s Triad

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There are a few DVT prevention modalities on the market – drugs that keep your blood from coagulating and forming

clots (called chemoprophylaxis or anti-coagulants) , anti-embolism stockings or intermittent pneumatic compression

devices (IPC). Clinical research shows that the most effective DVT prevention results come from a combination of

both of these modalities, also known as a multimodal approach.

Leveraging VenaFlow Elite’s enhanced design, unique technology and superior clinical message, we are poised to

take share from the existing market leaders. DJO’s Corporate goal is to become #2 in the marketplace within 7-10

years. VenaFlow Elite’s patented combination of normal inflation and graduated, sequential compression makes it the

only device on the market that mimics ambulation, which allows it to reduce DVT rates by 50% versus the market

leader. Getting patients to ambulate is the ultimate goal for preventing DVT, so a device that mimics ambulation is the

next best thing.

With such high disease incidence and fatalities, DVT inevitably costs healthcare facilities significant amounts in

treatment, long hospital stays and insurance claims. With a product that reduces DVT like VenaFlow Elite, we have

an avenue to reduce costs and help customers Walk Away From Risk altogether. The new recipe for winning is

calling on Quality Managers, Physician owners and Chief Financial Officers first and holding off on heading down the

path of least resistance - calling on the Materials Manager. The Elite sales strategy and training program will be

centred around this new paradigm in order to arm you all for great success in 2011 with VenaFlow Elite!


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Venous Thromboembolism (VTE) refers to the general blood clot disease state, including both DVT and PE.

According to Samuel Z. Goldhaber of Harvard Medical School, VTE is the number one cause of unexpected hospital

death. Not only is there an incredibly high and dangerous incidence of VTE per year, but there are high costs

associated with these complications. VenaFlow Elite, because of its ability to reduce DVT rates, will not only save

lives, but save money for our customers as well. The figures below should give you an idea of the scope of this

opportunity.

Incidence

“In the absence of prophylaxis, the incidence of objectively confirmed, hospital acquired DVT ranges from 10-40% in

the medical and general surgical population to as high as 40-60% in patients who have undergone orthopedic

surgery.” (ACCP Guidelines 2008)

– Approximately 100,00 to 200,000 VTE related deaths occur in the U.S. per year

– Approximately 300,00 to 600,000 VTEs occur in the U.S. per year

– Approximately 2 million symptomatic DVTs occur in the U.S. per year

– Approximately 10 million asymptomatic DVTs occur in the U.S. per year

VTE Costs to the Healthcare Provider*

► For every 10% reduction in DVT rates, facilities save an estimated $50,000-75,000 and at least 2 lives!

► Average per patient cost for DVT: $7,500 and for PE: $13,000

► Readmission for VTE occurs in 5 to 14% of patients

► Hospital readmission costs for DVT and PE respectively: $11,862 and $14,722 per patient

► 17% of PE cases and 36% of DVT cases go to the ICU and will incur double the initial DVT and PE treatment

costs

► There are approximately 33.7million U.S. hospital discharges per year

► About 1-1.8 % of hospitalized patients experience a VTE

► Average size hospital has approximately 4,500 discharges which translates to an estimated 45-81 VTE‟s, 15-27

Fatal PE’s, and 30-54 Symptomatic DVT’s

► Total annual incremental VTE cost to hospital on average is $420,000-756,000

► Including readmission rate, total VTE cost to hospital on average may be $462,000-831,000


* Based on estimated U.S hospital costs associated with VTEs

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DVT Legal/insurance Costs

► The total VTE cost to the U.S. Healthcare System is between $2-6 billion per year

► It takes approximately 4-5 years to resolve a malpractice claim

► Total annual healthcare malpractice insurance claim costs: $10.6 billion

► Total annual healthcare malpractice insurance premium costs: $34.5 billion

► Total per hospital annual malpractice insurance claim cost: $838,684

► Total per hospital annual malpractice insurance premium cost: $2,734,839

► Approximately 25% of a hospital’s total premium is based on experience

► If PE’s are the leading cause of preventable death in the U.S., and if approximately $683,710 in hospital

premiums are experience-based, then one can assume that a large percentage of that experience-based cost is

related to VTE

► VenaFlow Elite can help save approximately $684K in premiums and up to $800K in claims costs by reducing

DVT rates


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International Market Drivers

Although there are several threats to this market including severe price erosion and an increase in cuff

reprocessing, there is still a huge upside based on the increase of awareness and importance put on DVT

prevention in the last 5 years. This awareness is driving healthcare facilities to new protocols. There are also

opportunities outside of Orthopedics such as Plastics where there is less DVT awareness but the same level of

risk.

► Healthcare facilities are adopting more stringent DVT protocols and guidelines.

► Market shift from conventional compression therapeutics to include dynamic compression in hospitals markets

► Increasing number of procedures per year

► Awareness amongst patients about deep vein thrombosis and venous disorders

► Awareness of preventive healthcare and early detection and treatment

► Awareness about infection control has led to the introduction of disposable sleeves in the dynamic compression

pumps

► Education and training of physicians and patients to adopt new technologies

► Technological innovation enhances the growth of the market

► Move towards multimodal approach


The National Institute for Health and Clinical Excellence (NICE) in the UK published guidelines in January 2010 focusing on reducing the risk of DVTs in patients admitted to hospitals

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International Market Share Data

Kendall (also called Covidien) was first to market with a clinical “graduated, sequential” differentiator and

premium price, bundling with Kendall was first to market with a clinical “graduated, sequential” differentiator and

premium price, bundling with their other vascular products including TED stockings. Huntleigh swooped in with

a weak clinical story but a low cost strategy and took a piece of Kendall’s business and some new

business at the peak of DVT awareness. Aircast followed with VenaFlow, the only device to combine

normal inflation of the foot pumps with graduated, sequential compression.

The Western European market is estimated to be at $125 million with a 9% CAGR (2005 – 2015).


* Estimated market share based on 2009 Western European Frost & Sullivan for Mechanical Compression Therapy

DJO, 3%

Kendall,48%Huntleigh, 30%

Other, 19%

DJO

Kendall (estimate)

Huntleigh (estimate)

Other

Company Market Share

DJO 3%

Kendall/Covidien 48%

Huntleigh 30%

Other 19%

Total 100%

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Key Decision Makers - Hospital

In a hospital sell, you must oftentimes present VenaFlow to an entire Hospital product committee. In many

cases, all decision makers need to buy-in in order to win the business. It is imperative to understand the

decision makers’ buying criteria to ensure that you are prepared to respond to all potential objections.


Decision Maker Decision Criteria

Physician Clinical outcomes documentationPatient ComplianceNursing Acceptance

OR Director Ease of useClinical efficacy

Ward Managers Ease of use

Clinical Nurses Clinical efficacySafetyAlarms and compliancePump size

Nurse Educator Clinical efficacyEase of use

Materials/Procurement Management PricingInventoryGPO/IDN contractsPump requirements & responsibilityNursing acceptance

Risk/Quality Management DVT ratesCost of treatment vs. prophylaxisEvidence based practicePatient safetyReimbursementHospital finances

Senior Finance Administrators Hospital financesFacility reputation/PROverall business aspectPatient safety

Decision Matrix

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Key Decision Makers – Small Hospital/Surgery Centres


Decision Maker Decision Criteria

Nursing Director Financial/business aspectDaily operationsStaffProceduresProtocolsEfficiencyReputation of the facility

Key Clinical Nurse Product efficacyProduct application

Buyer/ Materials Manager PricingInventoryPump requirements & responsibilityNursing acceptance

Administrator PricingEase of use

Physician Owner Clinical efficacy

Decision Matrix

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Unmet Needs

VOC surveys and protostorming in gate 0 (gathered data from current customers, competitive customers and

field sales people) identified the following customer needs in a next generation VenaFlow device. These were

gaps/concerns from the clinical nurses and users as well as patients.

► Pumps too big/bulky

► Pumps difficult to stack/store

► Pumps too heavy

► Customizable bed hanger; pumps don’t fit on all specialty beds

► Pumps too loud; buzzing and vibrating

► Outdated appearance

► Appears not durable/breakable

► Easy to use without need for operator’s manual

► Universal power supply (one model for all countries)

► Compliance monitor

► No nuisance alarms

► DJO internal need: pump and cuff cost reductions due to eroding margin from rapidly eroding ASP


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Competitive Overview

Take note how each player is represented in terms of IPC technology. Kendall differentiates their product as

“graduated, sequential” whereas Huntleigh is a low cost competitor that offers neither technology. VenaFlow,

however, delivers both technologies for a high-performance, clinically-proven device that is more effective at

preventing DVT than the other products on the market!


IPC Technology Trade-offs – A Competitive Overview of Design Trade-offs

Lower performance, lower cost Higher performance, more cost

Single air-cell Multiple air-cells

Inflate simultaneously Inflate in sequence

Air-cells all inflate at the same pressure Air-cells all inflate graduated pressures

Slow inflation (10 seconds) Rapid inflation (≤ 1 second)

Low pressures Higher pressures

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Kendall













Huntleigh #2

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AV Impulse and PlexiPulse Foot Pumps













VenaFlow

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Competitive Overview – Kendall

► First to market and market leader

► Estimated global annual sales: $174 M

► Applies graduated, sequential compression but with slow inflation & circumferential compression

► Since 2010, owner of AV-Impulse®, a rapid foot compression device, globally

► Four new pumps introduced in the last 10 yrs

► SCD Express was launched in 2006

► small & light/added foot cuff and battery

► Intro of this pump & new garments led to much more aggressive pricing and local contracts

► Newest pump, SCD 700, launched in 2010

► Modern design, smaller than Express, adjustable bed hook, user friendly display

► New comfort sleeves launched, designed to minimise re-use and improve patient compliance

► Continues to sell based on differentiation; often bundles price with other vascular products


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Competitive Overview – Huntleigh

► Estimated global annual sales - $59 M

► Approximately 70% of their US revenue is IPC

► Single air-cell, slow inflation design

► Marketing focus on price and calf applications in 1998

► Does not differentiate, sells on price, GPO, ease of use

► Cuffs are composed of the same foam as the 3030-PL VF Foam Cuff

► Offers low-cost cuff – no binding on cuff edges

► Introduced Huntleigh Flowtron Trio in Spring 2009

► Trio is compatible with calf, thigh, and foot cuffs whereas the Excel only worked with calf and thigh cuffs. The

Trio cuffs are interchangeable with the Excel device


Flowtron Excel Flowtron Universal

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Value proposition

VenaFlow is the only DVT prophylaxis compression device that is proven to mimic ambulation, thus reducing DVT

rates by 50% vs. other devices. This is the best technology to protect patients and healthcare practices from the

rising risk of the DVT crisis.

Decision Making Criteria/Needs

– Surgeon: Clinical outcomes, patient compliance, nursing acceptance

– Nurse: Ease of use, safety, compliance, clinical outcomes, pump look/size

– Materials/Procurement Managers: Price, contracts, pump requirements and responsibility, nursing acceptance

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

Positioning Statement – “Walk Away From Risk”

(Play on words with “walk” – discuss how VenaFlow mimics ambulation)

► Walk Away From Risk With Technology: targeted toward clinical nurses and physicians

► Walk Away From Risk With Clinical Efficacy: targeted toward clinical nurses and physicians

► Walk Away From Risk With a Multimodal Approach: targeted toward clinical nurses and physicians

► Walk Away From Risk With Ease of Use: targeted towards charge nurses, scrub techs & other device users

► Walk Away From Risk Financially: targeted towards Quality/Risk Management and CFO’s & Administrators


Must be a clinical sell/message – need physician champions. Can no longer be successful targeting materials/procurement managers only

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Design Philosophy

The clinical performance of VenaFlow Elite is equivalent to the existing VenaFlow 30A offering. VenaFlow Elite

provides the same combination of technology.

– Normal inflation

– Graduated sequential compression

– Asymmetric compression

Because of this technology combination, it moves blood as quickly and efficiently as the 30A. However, there are a

few changes that have taken place. The VenaFlow Elite is now a single tube system. The single tube system is

called Integrated Graduated Sequential Flow (IGSF) and is merely a lower profile way to deliver the same effective

graduated, sequential compression that increases venous velocity.

Integrated Sequential Flow System (IGSF) is composed of a single tube system integrated into the duplex (dual)

air-cell.

► The distal air-cell inflates first within ½ a second at approximately 78mmhg +/- 15%

► Then at a certain pressure or “pinch” point the air flows into the proximal air-cell through that same single tube at

approximately 68 mmhg +/- 15%

► These pressures then settle at 45 mmhg +/- 15% and after 6 seconds, the cuff deflates.

► Inflation cycle indicator on the pump will signal when the inflation cycle is in progress (see Product Information)


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Design Philosophy

The pressure curve in Figure 1 shows how the distal and proximal peak pressures start out at different times and

different pressures. Then as time progresses, the settle pressures synchronize. It is critical however, to emphasize

the graduated, sequential nature of the inflation cycle when positioning it to the customer. That initial rapid inflow of

the distal air-cell first and then the proximal second is the key to increasing venous velocity.


Standard 30A VenaFlow System 30B VenaFlow Elite System

Dual tube system Single Tube system: (Integrated Sequential Flow System)

No battery Battery installation option: Part number 30B-B. Customer willinitially be charged for battery installed units and for batteryreplacements after the life of the battery expires (approximately2 years). See ‘Battery Information’ section.

Compliance counter Compliance Clock (digital): The LCD displays the treatmenthours, minutes and seconds.

Single leg operation: done by connecting free ends of tubing

Single leg operation: selected manually on display panel

Bed hanger: accommodates 2” width Telescoping bed hanger: accommodates up to 3.5” and allowscustom adjustability

Weight: 4 kg (9 lbs) Weight: 1.8 kg (4 lbs)

Figure 1

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Clinical Benefits

► Produces blood velocity and volume that mimics ambulation (Whitelaw)

► Proven to reduce DVT rates by 50% versus the market leader (Lachiewicz)

► Proven to reduce DVT rates when combined with chemoprophylaxis (Westrich Multimodal)

► Proven more effective at reducing DVT rates than TED hose (Silbersack)

► Normal inflation is proven to increase venous velocity, enhance fibrinolytics (breakdown of clots) and clean out

behind valve cusps where clots form

► Graduated, sequential compression is more effective than a non-sequential device at clearing blood from the

veins and preventing DVT (Nicolaides)

► Asymmetric design applies focused compression to the deep veins and sinuses, maximizing peak blood velocity

and total flow

Indications for Use

The VenaFlow Elite system is indicated as prophylaxis for deep vein thrombosis and pulmonary embolism. It is to be

prescribed for use by a healthcare professional.

The VenaFlow Elite system is designed to be used with the VenaFlow Elite compression cuffs.

The VenaFlow Elite cuffs are Single Patient Use only

Contraindications

The VenaFlow Elite system should not be used on persons with:

Known or suspected deep vein thrombosis, severe congestive heart failure, pulmonary oedema, thrombophlebitis,

severe arteriosclerosis, active infection.

Do not use on extremities which are not sensitive to pain, gangrene, on patients following vein ligation or recent

skin grafts,or extreme deformity of the leg.

Do not use where increased venous or lymphatic return is undesirable.


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Design Benefits

► Easy to use without the need for an operator’s manual

► Customizable fit to most specialty beds

► Compact and easy to store

► Less cumbersome tubing

► No matter how loose or tight the cuffs, pressure automatically adjust to deliver optimal performance

► Intuitive single-leg operation function

► Cool, breathable and comfortable cuffs

► Battery run version available

► Functions at maximum performance in any cuff position


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How to Read a Doppler

A Doppler provides information about the speed and direction of blood flow through the vein which also

indicates how well a compression device moves blood and thus prevents clots.

► Baseline velocity: blood flow velocity at rest when no ambulation or inflation is occurring

► Peak Velocity: the speed of blood flow at the point when the VenaFlow cuff is inflating. This is also what blood

flow looks like when a person is flexing their foot or walking.

► % Increase over baseline: When comparing Dopplers between competitive devices, it is best to look at the

percentage above baseline. This shows true blood flow achieved from just the device apart from normal flow.

Studies show that the higher the peak velocity, the lower the DVT rates.

Sample VenaFlow Doppler


Baseline Velocity

Peak Velocity

Blood Flow (m/s)

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Walk Away From Risk – Doppler Demonstration

See below how the Elite and standard VenaFlow devices move blood as quickly as normal physiologic

plantar/dorsiflexion.


Standard VenaFlow System110% increase in venous velocity over baseline

VenaFlow Elite System112% increase in venous velocity over baseline

Plantar/dorsiflexion111% increase in venous velocity over baseline

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Walk Away From Risk – Doppler Demonstration

The VenaFlow Elite device is differentiated as a device that not only mimics ambulation, but moves more

blood faster than the top devices on the market. You can visibly see that the blood peaks higher showing

faster blood flow than the Kendall and Huntleigh devices. No matter what price the competition offers, this

is the best device to protect their patients and their practice from the rising risk of the DVT healthcare

crisis.


VenaFlow Elite System112% increase in venous velocity over baseline

Slow inflation, SCD device i.e. Kendall Express, 50% increase in venous velocity over baseline

Slow inflation, uniform compression devicei.e. Huntleigh Universal, 33% increase in venous velocity over baseline

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Kendall (Covidien)


Kendall Feature Weakness VenaFlow Elite Value

Slow Inflation Rapid inflation only available inAV Impulse foot pump

SCD Express foot cuff – slowinflation with no clinical data

Rapid inflation for calf, thigh and footcuffs applies shear force to wall of veins that increases venous velocity, enhances fibrinolytics and cleans out valve cusps where clots form.

Circumferential compression Circumferential compression is notideal for achieving superior venousVelocity.

Asymmetric design applies focusedcompression to the deep veins andsinuses, maximizing peak blood velocity and total flow.

Sequential compression 3 chambers:45mmHg-lower40mmhg-middle30 mmHg –topSlow Squeeze– not as effective asrapid inflation

Sequential compression combined with rapid inflation is optimal to move blood and release fibrinolytics.

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Huntleigh


Huntleigh Feature Weakness VenaFlow Elite Value

Slow Inflation Calf cuff not rapid enoughto match the increase in blood velocity from dorsi/plantarflexion.

No research on foot cuff.

VenaFlow’s rapid inflationdemonstrates superior Dopplervelocity compared to Huntleigh’s.

Adjustable pressures Pressure levels can be adjusted; nurses can adjust to pressure levels that are not ideal.

VenaFlow has automatic pressurecycles so there is no adjustmentrequired.

Uniform compression with single air-cell in each cuff, not sequential

Research shows that sequentialcompression is superior.

VenaFlow’s duplex design withtwo overlapping air-cells providesgraduated sequential compressionfor ultimate venous velocity.

Preset alarms Staff in-servicing for presetsand alarms is complicated.

Preset alarms are easier to use andactivate in low pressure, high pressure and kink scenarios.

Bed Hanger Handle not integrated into case. VenaFlow has telescoping handlebuilt into case and compatible with most specialty beds.

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Medical Compression Systems


MCS Feature Weakness VenaFlow Elite Value

Slow Inflation Not rapid in foot, calf or thigh cuffs. Inflates within 10 seconds. Claims issynchronized with physiologic blood flow, but without normal inflation, we know that’s not the case.

VenaFlow Elite inflates within ½second and is true normal inflation. VenaFlow Elite’s combination of normal inflation and graduated, sequential compression has been proven to mimic ambulation and reduce DVT by 50% over slow inflation devices.

Sequential compression Sequential, but not graduated. Applies 50 mmhg into three ports of the calf. Without normal inflation,you don’t get the performance you need to effectively prevent DVT.

VenaFlow’s duplex design withtwo overlapping air-cells providesgraduated sequential compressionfor ultimate venous velocity.

Portable and battery run Frequent alarms, not powerfulenough to achieve full pressures; pumps get stolen easily.

VenaFlow Elite has minimal to nonuisance alarms and its higher pressures and normal inflation make it more effective at moving blood.

Recent study done Not enough experience in thefield; should have more studies proving design and hemodynamics.

Multiple studies both past and recent proving VenaFlow’s efficacy.

Tubing Exits towards the waist. Not conducive to patient compliance.

VenaFlow Elite tubing exits toward the foot and is much more comfortable to promote patientcompliance.

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Walk Away From Risk - A Winning Sales Strategy

Section 5: Sales & Strategy Overview

► This Sales & Strategy overview provides sellers with a proven process to effectively sell to each key decision

maker in hospitals and other healthcare establishments.

► Although the job title of the decision maker may be different in each market, the process gives examples of the

type of person who should be targeted.

► Quality Manager/Nurse Manager

► Lead Physician Owner/Lead Physician

► Business Manager/Chief Financial Officer

► Materials Manager/Procurement

► Nurse, Scrubs Techs, OR Coordinator

Key Sales Message

“VenaFlow is the only DVT prophylaxis compression device that is proven to mimic ambulation thus reducing DVT rates by 50% vs. other devices. This is the best technology to protect patients and healthcare practices from the rising risk of the DVT crisis.”

Target Decision Makers/Influencers

► Quality Manager/Nurse Manager:- DVT rates & cost, patient safety, reputation, minimal disruption

► Lead Physician Owner/Lead Physician:- Clinical outcomes, patient compliance, nursing acceptance

► Business Manager /Chief Financial Officer:- DVT rates, business success, value impact, clinical outcomes

► Materials Manager/Procurement:- Price, procurement contracts, pump requirements and responsibility, nursing

acceptance

► Hands-on Staff:- Ease of use, safety, compliance, clinical outcomes, pump look/size

Decision Making Criteria/Needs

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It is vital to understand this new sales process for VenaFlow selling. You have the ability to win by following this

process and delivering the right clinical message.


Gather data on key target competitive accounts and respective expiration dates to build a working sales funnel.

Your first meeting in any hospital or surgery centre target should be with this decision maker. This individual is your gatekeeper, not the Materials Manager. Your goals with this individual are to develop rapport and sell them on the economic model.

Leverage Quality Manager relationships to access physician owner who is in charge of DVT prevention. The goal here is to communicate the Walk Away From Risk clinical story, ease of use and cuff comfort for increased compliance.

Through relationships built with Physician and Quality Committee, you should be able to get an audience with the CFO or Business Manager who as business owners care about overall value and financial impact to their business entity. The goal is to sell company credibility, the economic model as well as DVT rate improvement.

Lastly you meet with materials/procurement manager and convince them you are a better overall business partner with minimal change and a simple solution at an equivalent or lower price.

Step 1 - Data Gathering

Step 2 - Call on Quality/Nursing Manager

Step 3 - Physician Owner/Lead

Step 4 – CFO/Business Manager

Step 5 – Materials/Procurement Manager

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Targeted Sales Message

Below is an example of the overall sales message for each decision maker based on their needs and their buying

criteria. You should have an overall understanding of the general sales messages in preparation for your sales calls.


Quality/Nursing Manager

► Using VenaFlow Elite can help reduce your DVT rates by 50% versus the product you are currently using

► Not all pumps are the same. VenaFlow is the only device that mimics ambulation because of its unique and patented technology

► For every 10% reduction in DVT rates, you can save $50,000 to $75,000. We can provide this reduction in DVT rates for you that will ultimately save you money

Physician Lead

► For the safest, most clinically proven and effective DVT prevention, you need both normal inflation and graduated, sequential compression

► VenaFlow Elite’s cuffs are soft, breathable and comfortable and help to promote patient compliance

► The Number 1 litigation in hospitals today is related to DVT. VenaFlow is the only device that mimics ambulation and is the best technology to protect patients

CFO/Business Manager

► An average hospital carries an annual VTE cost burden of approximately $420,000 to $756,000

► For every 10% reduction in DVT rates, you can save $50,000 to $75,000. We can provide this reduction in DVT rates for you that will ultimately save you money

► VenaFlow Elite can help save approximately $684K in insurance premiums and up to $800K in claims costs by reducing DVT rates

Materials/Procurement Manager

► We will work with you to provide the best supply chain system and make ordering easy. We bring you a better overall business partner.

► The Quality Manager, Chief Physician and CFO all want to use VenaFlow so we’ll work with you to come up with the right price

► Let me show you the research on TED hose vs. IPC devices as we may be able to find a cost savings for you there

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Walk Away From Risk Financially

►This selling scenario is specifically targeted for Quality/Risk Managers or CFO/Business Managers who care about the reputation of their facility and who gather data on DVT rates. It is important to show them how using VenaFlow Elite will lower their DVT rates and ultimately save them money. Bear in mind that this example follows the US finanancial analysis.

Approach: Using VenaFlow Elite can save your facility money by reducing your financial risk.

Open Probe: Do you know approximately how much you spend treating VTE annually?

Quality Manager response: Actually I don’t have the numbers offhand but it’s not that high, our DVT rates are pretty low.

Magnifier: Did you know that every 10% reduction in DVT rates reduces hospital losses by about $50-75,000 year and at least 2 lives?

Demonstrate value: • For every 10% reduction in DVT rates, facilities save an estimated $50,000-75,000 and at

least 2 lives!• Average per patient cost for DVT: $7,500 and for PE: $13,000• Readmission for VTE occurs in 5 to 14% of patients• Hospital readmissions costs for DVT and PE respectively: $11,862 and $14,722 per patient

• 17% of PE cases and 36% of DVT cases go to the ICU and will incur double the initial DVT and PE treatment costs

• There are approximately 33.7million U.S. hospital discharges per year• About 1-1.8 % of hospitalized patients experience a VTE

• Average size hospital has approximately 4,500 discharges which translates to an estimated 45-81 VTE’s, 15-27 Fatal PE’s, and 30-54 Symptomatic DVT’s

• Total annual incremental VTE cost to hospital on average is $420,000-756,000• Including readmission rate, total VTE cost to hospital on average may be $462,000-

831,000

Potential objection:• We use anti-coagulants so we control DVT pretty well• Well, yeah our costs really aren’t that high since we use SCDs for all surgeries over an

hour.

Objection response:• Eisele study shows “Venous thrombosis prophylaxis with low-molecular-weight-heparin,

augmented with a rapid-inflation intermittent pneumatic compression of the calves (.4% dvtrate) was found to be significantly more effective for preventing deep vein thrombosis when compared with a treatment of LMWH alone (1.7% dvt rate).”

• Lachiewicz study shows a 50% reduction in DVT rates with patients using VenaFlow vs. Kendall slow inflation device. VenaFlow can save the hospital $50,000 or more by being more effective at preventing DVT.


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This tool is in an Excel spreadsheet and can be modified for your own currency if needed. The figures are based on US percentages.

The blue cells are the unlocked input cells that you will fill in with the facility’s number of beds and the percent decrease in DVT rates that VenaFlow will provide.

Please contact Amy Armstrong for file.

Venous Thromboembolism (VTE)Cost Savings Estimation Tool

Number of Hospital Beds 100

Number of VTE Cases 21DVT Cases 14VTE Cases 7

Total VTE Cost $294,405

% Reduction in VTE Cases30%(versus competition)

Revised number of VTE Cases 14.7Revised DVT Cases 9.8Revised VTE Cases 4.9

Total Cost Savings $88,321 First Patient Stay

% of patients experiencing VTE 1.00%DVT Cost per Patient $7,500 PE Cost per Patient $13,000

ICU Costs

% of DVT patients that visit ICU during stay 36.00%DVT Cost per ICU Patient $7,500

% of PE patients that visit ICU during stay 17.00%PE Cost per ICU Patient $13,000

Readmitted Patient Stay% of VTE patients readmitted for second stay 14.00%

DVT Readmission Cost per Patient $11,862

PE Readmission Cost per Patient $14,722

ICU Costs

% of DVT patients that visit ICU during stay 36.00%DVT Cost per ICU Patient $7,500

% of PE patients that visit ICU during stay 17.00%PE Cost per ICU Patient $13,000


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Average VTE Case Reduction by Hospital Size


30% Reduction in VTE Cases

Hospital Beds VTE Cases VTE Expense Revised Cases Cost Savings50 10.5 $ 147,202 7.4 $ 44,161

100 21.0 $ 294,405 14.7 $ 88,321 150 31.5 $ 441,607 22.1 $ 132,482 200 42.0 $ 588,810 29.4 $ 176,643 250 52.5 $ 736,012 36.8 $ 220,804 300 63.0 $ 883,215 44.1 $ 264,964 350 73.5 $ 1,030,417 51.5 $ 309,125 400 84.0 $ 1,177,620 58.8 $ 353,286 450 94.5 $ 1,324,822 66.2 $ 397,447 500 105.0 $ 1,472,024 73.5 $ 441,607



100 21.0 $ 294,405 12.6 $ 117,762 150 31.5 $ 441,607 18.9 $ 176,643 200 42.0 $ 588,810 25.2 $ 235,524 250 52.5 $ 736,012 31.5 $ 294,405 300 63.0 $ 883,215 37.8 $ 353,286 350 73.5 $ 1,030,417 44.1 $ 412,167 400 84.0 $ 1,177,620 50.4 $ 471,048 450 94.5 $ 1,324,822 56.7 $ 529,929 500 105.0 $ 1,472,024 63.0 $ 588,810



100 21.0 $ 294,405 10.5 $ 147,202 150 31.5 $ 441,607 15.8 $ 220,804 200 42.0 $ 588,810 21.0 $ 294,405 250 52.5 $ 736,012 26.3 $ 368,006 300 63.0 $ 883,215 31.5 $ 441,607 350 73.5 $ 1,030,417 36.8 $ 515,209 400 84.0 $ 1,177,620 42.0 $ 588,810 450 94.5 $ 1,324,822 47.3 $ 662,411 500 105.0 $ 1,472,024 52.5 $ 736,012

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Walk Away from Risk with Technology

Knowing how VenaFlow Elite’s technology is differentiated and how it gives us a competitive advantage is critical to conversations with Quality Managers, Physicians and CFOs. It is important to find out which pump they are using in order to tailor your discussion based on the technology with which they are familiar.


► Open Probe: I’m sure DVT prevention is one of your facility’s top concerns. Would you be

interested in learning about a device that has been shown to improve outcomes by 50% when

compared to the other devices?

► Nurse/Physician response: Sure but aren’t all pumps the same? How is yours different from the

one I’m using?

► Magnifier: Actually there are differences in the various pumps on the market. Are you aware of

the research that supports the benefits of normal inflation combined with graduated, sequential

compression? Do you know if the pumps you’re using are normal, graduated sequential or single

squeeze?

Identify which pump the customer is using and use respective demonstrate value response below to highlight the clinical superiority of VenaFlow’s normal inflation and graduated, sequential compression combination at moving blood and preventing DVT.

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If the account is currently contracted with Kendall, here aresome helpful clinical points from studies to share with them asevidence of the VenaFlow Elite’s clinical efficacy that results from its unique patented technology combination.


Kendall – slow inflation devices

Demonstrate value:

The VenaFlow platform technology that is also featured in the new VenaFlow Elite has an effectivecombination of normal inflation and graduated, sequential compression. This technology combination catalyzes the body’s normal inflation response by stimulating the endogenous fibrinolytic activity needed to protect patients who are immobile post-operatively from the risk of DVT. (Gardner and Fox, 126; Comerata, 310)

► “[Slow inflation devices] do not mimic normal physiologic venous pump action. They may be ineffective in preventing the more dangerous proximal deep venous thrombosis.” (Gardner and Fox)

► “Intermittent pneumatic compression with a faster inflation rate dramatically increases blood flow, generates greater shear stress on the vascular wall, stimulates greater nitric oxide release, and consequently results in stronger responses of vasodilation when compared with intermittent pneumatic compression with a slower inflation rate.”¹ (Kang Liu et al)

► “Roberts et al established that devices with a greater rate of inflation produced improved flow augmentation as compared with those with a slower rate of inflation.VenaFlow produced the greatest increase in peak venous velocity compared with all the other devices” (Westrich, 04302)

► “The use of elliptical, sequential and rapid-filling compression of the leg with overlapping aircells produces significant hemodynamic changes in the common femoral vein, which are superior to other sequential slow or rapid-filling IPC devices.” (Labropoulos, 04356)

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If the account is contracted with Huntleigh, it is essential to provide the same evidence on normal inflation as with the Kendall user, but additionally you must discuss the clinical importance of graduated, sequential compression to moving blood and preventing DVT.

Huntleigh, uniform compression and slow inflation

Demonstrate value:The VenaFlow platform technology that is also featured in the new VenaFlow Elite has an effective combination of normal inflation and graduated, sequential compression. This technology combination catalyzes the body’s natural response of stimulating the endogenous fibrinolytic activity needed to protect patients who are immobile post-operatively from the risk of DVT. (Gardner and Fox, 126; Comerata, 310)

► Graduated, sequential compression devices are more effective than a nonsequential device in clearing blood from the soleal, tibial and femoral veins and therefore is more effective at preventing deep venous thrombosis proximal to the calf. (Nicolaides 15016)

► Research shows that graduated, sequential compression helps to maximize the indices of flow rate, velocity and vein wall shear stress, resulting in more effective DVT prevention than uniform compression. “Uniform compression was substantially inferior to cycles with gradation and sequencing.” (Kamm15020)

► “Intermittent pneumatic compression with a faster inflation rate dramatically increases blood flow, generates greater shear stress on the vascular wall, stimulates greater nitric oxide release, and consequently results in stronger responses of vasodilation when compared with intermittent pneumatic compression with a slower inflation rate.”¹ (Kang Liu et al)

► “Roberts et al established that devices with a greater rate of inflation produced improved flow augmentation as compared with those with a slower rate of inflation.VenaFlow produced the greatest increase in peak venous velocity compared with all the other devices” (Westrich, 04302)

► “The use of elliptical, sequential and rapid-filling compression of the leg with overlapping aircells produces significant hemodynamic changes in the common femoral vein, which are superior to other sequential slow or rapid-filling IPC devices.” (Labropoulos, 04356)


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If the account uses rapid foot pumps, demonstrate evidence that calf cuffs are more effective at moving more blood faster and the fact that VenaFlow is the only true “normal inflation” device that offers all three cuff configurations.

Foot pumps, rapid but only in a foot offering

Demonstrate value:The “rapid” foot devices on the market are good, but VenaFlowis the only device on the market with true normal inflation in thecalf, foot and thigh in one universal pump. Normal inflation of thefoot still moves blood, but normal inflation in the calf actuallymoves more blood faster. In the diagram of the body’s naturalfoot pump mechanism (see diagram below), you see that thecalf contains a larger volume of blood and the firing of the calfmuscle helps to more effectively move that higher volume ofblood faster. Therefore, calf cuffs that inflate rapidly are the mosteffective means of preventing DVT because they moreaccurately mimic ambulation.


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Potential objection:I thought my current pump was normal inflation

Objection response:VenaFlow Elite inflates within ½ second, whereas the other devices on the market inflate within 4to 12 seconds depending on the device.

VenaFlow Elite Calf Cuff Pressure Curve

0

10

20

30

40

50

60

70

80

90

0 1 2 3 4 5 6 7

Time [sec]

Pres

sure

[mm

Hg]

distal

proximal

►Not only does VenaFlow move blood similar to the way our bodies do when we are ambulatory, but it moves blood faster than the other devices on the market, including the rapid inflation foot devices. (Whitelaw, 04337)


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Walk Away from Risk with Clinical Efficacy

Approach: VenaFlow Elite’s effective technology combination produces blood velocity thatmimics ambulation, which is what helps to reduce DVT.

Open Probe: Would you agree that after the patient is ambulatory that they no longer needa pneumatic compression device?

Nurse/physician response:Yes I would agree. DVT risk is present when they arerecovering and not yet ambulatory.

Magnifier: That is exactly what VenaFlow Elite does. It mimics ambulation. The latestvascular research shows that a device that mimics ambulation and produces high bloodvelocity creates turbulence in the vein which helps clean out valve cusps where clots like toform.

Demonstrate value: By mimicking ambulation, VenaFlow Elite technology is the best wayto protect your patients and your practice from the risks associated with DVT.

Potential objection: Well I use a different pump and my DVT rates are pretty low.

Objection response:The Lachiewicz study proves that VenaFlow reduces DVT rates by 50% when compared tothe typical slow inflation SCD device on the market. Also Gardner and Fox stated that“because of their slow inflation rates, they do not mimic normal physiologic venous pumpaction. They may however be ineffective in preventing the more dangerous proximal deepvenous thrombosis.” (Lachiewicz, 04368)“Peak velocity and shear stress have been shown to increase in sequential compressionmodels, decreasing stasis and increasing fibrinolytic activity.” (Labropoulos, 04356)Now let me show you Dopplers of your current device vs. VenaFlow.

►Similar to Walk Away From Risk With Technology, this selling scenario is designed for Quality Managers, Physician leads and C-Suite staff. After you have overcome any objections pertaining to technology, you can show these decision makers the effect the technology has on hemodynamics with Doppler images. This is extremely compelling, especially when comparing VenaFlow Elite to competitive Dopplers.


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Walk Away from Risk With Multimodal Approach

►This scenario is yet another clinical discussion to have with clinical decision makers such as physicians, nurse managers and/Service Line Managers. This discussion is tailored to facilities that may only use chemoprophylaxis and who have room to adopt more stringent IPC protocols. You can use the clinical points below to emphasize the importance and general acceptance of the multimodal approach.

Approach: The VenaFlow Elite used in combination with Low Molecular Weight Heparin(LMWH) or other anti-coagulants is a more effective means of DVT prevention thanchemoprophylaxis alone.

Open Probe: Are you using IPC devices in addition to anticoagulants? If not, why?

Nurse/physician response: We have a few IPC devices for the high risk surgeries, butoverall we’ve had great success with anticoagulants so we are fine with using that for themajority of cases.

Magnifier: If I could prove that using IPC devices in conjunction with anticoagulants woulddecrease your DVT rates, would you reconsider using more pumps in your hospital?

Demonstrate value: Run through the results of the Eisele and Westrich Multimodal studieson this page.

Potential objection: Well I use anti-embolism stocking with anticoagulants, so I don’t reallyneed to add IPC to my protocol too.

Objection response:The Silbersack study shows that with the combined use of LMWH and IPC in TKRs andTHRs, the DVT rate was zero. However for the patients with LMWH and stockings there wasa 28.6% DVT rate. So “combined prophylaxis with LMWH and IPC is more effective thanLMWH used with graduated compression stockings. (Silbersack, 04371)


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Walk Away from Risk With Ease of Use

►This selling scenario should be targeted to Floor Managers, Nurse-Educators, Administrators, Scrub Techs or any influencers who are hands-on with IPC devices. This discussion shows them what benefits the Elite has over the competition in terms of ease of use.

Approach: VenaFlow Elite leverages the clinically proven VenaFlow platform technology while featuring a new, low profile and light-weight appearance.

Open Probe: 1. What would you change about the SCD you currently use?2. Do you have any compliance issues with your current device and why?

Nurse response:I get a ton of false alarms with the pump we use. It wakes the patients up and it’s a major nuisance in the OR. Secondly I have trouble with the pumps fitting on our beds; we end up putting them on the floor. Also the cuffs are hot and the patients don’t like them.

Magnifier:Have you seen and tried our most recent offering, the VenaFlow Elite?

Demonstrate value: VenaFlow Elite’s new low profile, light-weight design features a telescoping bed hanger that extends to 3.5” and can fit on most specialty beds. We also have all preset alarms and pressures that adjust automatically based on the tightness of the cuff. Our cuffs are made of soft, cool and breathable nylon material that helps increase patient compliance.

Potential objection:But does it have a battery? We require 25% of our pumps to be battery operated.

Objection response: Yes the Elite version is available with a battery installed. The battery has a 2 year life and automatically charges when plugged in. The device will run for 2 hours on battery power.


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Other Suggested Open Ended Selling Questions

1) What specific pumps are you using?

2) Which types of cases are you using “brand x” on?

3) Do you use calf, thigh or foot cuffs? How many cuff pairs do you purchase per month?

4) Do you rent pumps monthly or weekly? How many times per month do you wish you had access to more without renting?

5) Do you purchase your cuffs direct from the manufacturer, or do you go through a distributor?

►Talk about relationships we have with 3rd party distributors►Let them know we can service them through either channel

6) What is your current minimum order quantity of cuffs?►You can order VenaFlow in any quantity you want, you are not subject to a minimum order quantity

7) What is your yearly maintenance charge?►DJO does not charge any maintenance charges like some of the other manufacturers do.

After you have presented the need, the features and benefits, clinicals, and competitive advantages, ask for the business!!

Competitive business:►Have you seen the Doppler comparisons between your pumps and ours?►Is this something we can switch out for you this week?

Doesn’t currently use IPC device:►Can I bring in some product for you to trial?


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Other Objection Responses

Objection #1: “Our surgeries are so short, we don’t need DVT prophylaxis.”

Response: ►There is a growing interest/awareness of DVT prophylaxis even for brief cases – ex. core measures, etc.►High risk patients need DVT prophylaxis even for short cases; we have heard it is used for surgeries 30 minutes or more►One patient getting DVT could draw unwanted attention to your facility as well as impact you financially. Prevention is key.

Objection #2: “This is too cost prohibitive for us”

Response:►We have a consignment model in which we consign pumps at no charge to you and require the purchase of only 36 cuff pairs per pump per year, which is less than 1 pair per week►This minimal expense is worth it to protect the physicians’ interest and the reputation of the clinic

Objection #3: “We move so quickly between cases, we don’t have time to bother with DVT prophylaxis.”

Response:►VenaFlow set up is easy and has preset pressures and alarms, so there are no adjustments required►You can leave a pump in the busiest room so it is ready for the case.

Objection #4: “I don’t schedule cases very far in advance so I couldn’t stock inventory.”

Response:►It isn’t necessary to keep a great deal of inventory on hand because the cuffs don’t take up much space, they come in one size fits all and can be trimmed, we don’t have minimum orders, and the pumps are compatible with all three cuff styles. Our customers typically only need to keep approximately 5-10 pairs on hand.


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Section 6: Sales Support Materials

Marketing Collateral Update:

► Launch Binder

► Data Sheet

► VenaFlow Doppler Comparison DVD

► VenaFlow In-service Guide

► VenaFlow In-service DVD

► Excel Spreadsheet - Cost Savings Estimation Tool

► Clinical Studies (Available on RepNet)

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1) Eisele Study, part #05000

Rapid-Inflation Intermittent Pneumatic Compression for Prevention of Deep VenousThrombosis; Eisele R, Kinzl L, Koelsch T:J Bone Joint Surg Am. 89: 1050-6, 2007

Description: Randomized, prospective study with 902 patients with Low Molecular Weight Heparin (LMWH) blood thinners were compared against 901 patients using LMWH with VenaFlow. The LMWH alone group had 1.7% DVT rate vs. the LMWH with VenaFlow which had a 0.4% DVT rate.

Results: A rapid inflation intermittent pneumatic compression device (VenaFlow) combined with LMWH is significantly

2) Labropoulus Study, part #04356

Improved Venous Return By Elliptical, Sequential and Seamless Air-cell Compression; LabropoulosN, Oh DS, Golts E, et al: International Angiology 22(3): 317-321, 2003

Description: Kendall thigh and VenAssist (Art Assist) device hemodynamics are compared to that of the VenaFlow Calf System.

Results: “The Use of elliptical, sequential and rapid-filling compression of the leg with overlapping aircells produces significant hemodynamic changes in the common femoral vein, which are superior to other sequential slow or rapid-filling IPC devices.”

3) Westrich Multimodal Study, part #04374

“Thromboembolic Disease Prophylaxis in Patients With Hip Fracture, A Multimodal Approach” Hospital For Special Surgery, 2005.

Description: Combined pneumatic compression (VenaFlow system) with chemical prophylaxis(warfarin and aspirin).

Results: Suggested that pneumatic compression with the VenaFlow calf in conjunction with chemical prophylaxis is an effective means of reducing thromboembolic disease in the high risk population of hip fracture patients.

4) Lachiewicz Study, part #04368

“Two Mechanical Devices For Prophylaxis of Thromboembolism After Total Knee Arthoplasty”: University of North Carolina, 2004.

Description: Randomized prospective study comparing the incidence of DVT following total knee arthroplasty using two devices - the Kendall thigh SCD and the VenaFlow calf system.

Results: Patients who received VenaFlow were 50% less likely to develop a DVT than those patients who received Kendall thigh SCD.

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5) Silbersack Study, part #04371

“Prevention of Deep Vein Thrombosis After Total Hip and Knee Replacement”: Martin Luther University Halle/Salle, Germany, 2004.

Description: Compared the efficacy of intermittent pneumatic compression in conjunction with LMWH to that of anti-embolism stockings with LMWH in patients undergoing primary unilateral THR or TKR.

Results: Compression ultrasonography showed no evidence of thrombosis in the patients that used LMWH and intermittent pneumatic compression whereas there was a 28.6% DVT rate with the group using compression stockings with LMWH, thereby suggesting that stockings are not as effective as IPC devices in preventing thrombosis. (Part #04371)

6) Whitelaw Study, part #04337

“Evaluation of Intermittent Pneumatic Compression Devices”: Whitelaw GP, Oladipo OJ, Shah BP, et al: Orthopedics, March, 2001.

Description: Compared blood flows of VenaFlow calf, Jobst Calf, Jobst Thigh, Kendall Thigh, Venodyne Calf, PlexiPulse Foot and Plantar/dorsiflexion.

Results: Demonstrates that the VenaFlow system is the only DVT prophylaxis on the market that produces peak venous velocities that match blood flows achieved through plantar/dorsiflexion.

7) AORN Guidelines for Prevention of Venous Stasis (insert in 00-0616 Surgery Center Packet)

AORN Journal, 85(3):607-624, 2007

Description: The purpose of the guideline is to provide a framework that perioperative team members and others can use to develop polices, procedures, and protocols for prevention of venous stasis and DVT/PE.

Results: According to the guidelines, IPC devices should be turned on before the beginning of induction of general anesthesia or before regional anesthesia has been administered. Plan of care should be considered for procedures lasting longer than 30-45 minutes.

8) NICE Guidelines; Venous thromboembolism: reducing the risk.

Jan 2010, NICE clinical guidance 92

Description: Guidance issued to all hospitals in England and Wales to cover all hospitalised patients. Provide guidance on assessing all patients and selecting the most appropriate prophylaxis possible.

Results: All surgical patients should be offered mechanical prophylaxis to include anti-embolism stockings, foot impulse and intermittent pneumatic compression. Pharmacological modalities can be used in all patient groups as long as the correct risk assessment has been made.

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Bed hanger release

Pump indicator lights

Telescoping bed hanger

Graphical display

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Tube Alarm

If one or both tubes has a kink or leak, after 4-6 minutes thissymbol and the text “CHECK TUBES” will alternate on thegraphical display, an audible alarm will sound and the pumpindicator lights on the side of the system will flash red.

Single/Dual Leg Alarm

Once powered on, the VenaFlow Elite System will default todual leg operation mode. In the event that the selected legoperation mode and the number of cuffs attached do notmatch, after 4 minutes, an audible alarm will sound and thissymbol will appear on the graphical display along with thetext, “LEG ALARM”. Additionally, the pump indicator lights onthe side of the system will flash red.

A leg alarm will activate if either of the following occur:

•Single leg use is desired, one cuff is connected, but the single leg operation button is not pressed within 3 minutes after powering on the device.

•Single leg operation button was pressed within 3 minutes of powering on the device, but two cuffs are connected.

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Compliance Alarm

This feature is currently disabled from every device that will be shipped to a customer. During our beta site testing, we found some devices were false alarming (visual alarm only), so we disarmed it. Once we improve the system, we will install this feature. It is described below.

Call for Service Alarm

• If the cuffs are removed from the patient while the deviceis still functioning and the cuffs are not reapplied after 15minutes, a visual alarm will flash and the graphical displaywill read “COMPLIANCE ALARM”. Additionally, the pumpindicator lights on the side of the system will flash red.

If one of the system’s critical components is not workingproperly, the Call For Service alarm symbol will appear onthe graphical display and it will alternate with the text “CALLFOR SERVICE”. Additionally, the pump indicator lights on theside of the system will flash red.

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Battery Information

The VenaFlow Elite is available with or without a battery installed inside the device. If an account chooses to order battery units (30BI-B), they will be responsible to pay a fee per pump with the initial consignment order. Then the account would also be responsible to pay for each replacement battery needed thereafter outside of the 1 year battery warranty. They will have the option of ordering a battery kit and replacing it themselves for a charge or sending the pumps back and having DJO replace at a higher premium.

If the device is installed with a battery, the battery icon featured above will appear in the top right hand corner of the display when powered on. Additionally, there is a sticker on the device indicating that it is a battery installed system.

Important: The battery must be charged before use. To charge the battery, simply plug in the device while it is powered on or off. Powered on it takes 4 hours to charge, powered off it takes 2 hours. A fully charged VenaFlow Elite device will last approximately 2 hours.

Low Battery Alarm

1) When there is approximately 15 minutes of charge left in the battery, an audible alarm will beep 3 times every minute. When there is less than approximately 5 minutes of charge left, a consistent beep will sound and a larger version of the battery icon will appear on the graphical display and it will alternate with the text “LOW BATTERY”.

2) When either battery alarm occurs, immediately plug device in to electrical outlet to begin replenishing the charge.

3) If the device is not plugged in during the alarm period, the device will shut down and will fail to power on again until the device is plugged in again.

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Section 9: Sizing, Pricing and Ordering Information

Part Number Description Qty

MaxCalf

Circumference

Recommended Int’l Mkt Price

(List -10)30BI VenaFlow Elite System, International 1 N/A $ 1,400.00

30BI-B VenaFlow Elite System with Battery, International 1 N/A $ 1,500.00

3040 VenaFlow Elite Calf Cuff Pair 48.26cm (19”) $ 30.00

3041 VenaFlow Elite Sterile Calf Cuff Each 48.26cm (19”) $ 40.00

3042 VenaFlow Elite XL Calf Cuff Pair 55.88cm(22”) $ 30.00

3043 VenaFlow Elite Bariatric Calf Cuff Pair 76.2cm(30”) $ 40.00

3044 VenaFlow Elite Sterile XL Calf Cuff Each 55.88cm(22”) $ 40.00

3045 VenaFlow Elite Thigh Cuff Pair One size $ 45.00

3046 VenaFlow Elite Foot Cuff Pair One size $ 50.00

3050 VenaFlow Elite Foam Calf Cuff Pair 48.26cm (19”) $ 22.00

3008 Tube Assembly, 1.68m(5.5‘) Each $ 30.00

3008XL Tube Assembly, 2.6m(8.5‘) Each $ 35.00

3008XXL Tube Assembly, 3.2m(10.5‘) Each $ 35.00

3008XXXL Tube Assembly, 3.8m(12.5‘) Each $ 40.00

System Replacement Parts

3071 Bed Hanger 1

3072 Tube Attachment Tag 1

3073 Fuse Pair

3074 Battery Pack 1

Pricing Guidance Information

• VenaFlow Elite may be purchased or sold on consignment.

• For consignment units, each contract will need to be negotiated on an individual basis based on competitive pricing. Each contract needs to be approved by your General Manager.

• When necessary, discounting would be acceptable. Please consult your General Manager for guidance.

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Section 10: Post Launch Dashboard

This type of Post Launch Dashboard will be created and distributed to measure sales performance as well as provide useful information (i.e. Success Stories), which may help others win business in their markets. Top performing Sales Reps will also be recognized for their success.

Unit Sales by Geographic Distribution

May 2011Launch Dashboard

2011 YTD Units & Sales Revenue

Next Steps

Comments from the French Sales Team:• The Original tag and stickers are “SUPER” and stand out!• The drawings in the Launch package/Brochure comparing AS II system vs.

Competitors is absolutely perfect and “they don’t need to talk more!”• The mesh is very good and some said it will help them to regain customers

that were not satisfied with the AS Classic that did not have this feature.

Challenges

• Lowering cost of goods and labor time by approximately $2.00 - $1.50. • Implementing new “softer” strap• Implementing new Aircast box (to fit large size better)

We have experienced back order issue due to:• Demand higher than originally forecasted• Product strategy shifting in some markets• Back orders caused by spacer mesh shortage and Oracle/JDE issue

AIR-STIRRUP II TM

G-A-S51%France

31%

Italy9%

Spain 2%

Export 3% Canada 1% UK 1% Nordic 1%

2011 Q1 YOY Analysis(Air-Stirrup + Air-Stirrup II combined)

Feedback from the Field

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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.

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.

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).

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.

Venous thromboembolism (VTE):

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

Section 11: Glossary of Terms

Documents

VenaFlow Walk Away From Risk - DJO Globalstorage.djoglobal.eu/.../Marketing...binder_lo_pdf.pdf · The Western European market is estimated to be at $125 million with a 9% CAGR (2005