The Eucomed Monitorings in Europe

EHRA Summit, Heart House, Sophia Antipolis, March 16th, 2009

Oern R. Stuge, MD, MBAMember of the Eucomed Board of Directors

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Eucomed: - Voice of Medical Technology

European Medical Technology Industry Trade Association

Field: Prevention, treatment and amelioration of disease and disabilityEucomed represents:

4500 companiesTotal Employment 435,000 people. (2007)Total revenue of member companies; 63.6 bn Euros

Board of Directors: Corporate and Association representatives

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Eucomed Monitorings of CRM Devices

Started in 2003 – present

Annual collection from the different device manufacturers till end 2004

Quarterly since Q1-2005

Result:Implants per million inhabitants per country –European countries•ICD, CRT-P, CRT-D, IPGs

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Low Power Devices - Implant per Million Inh

The 2008 Preliminary data cannot to be shared, and has been replaced with the 2007 dataFinal implant rates for 2008 will be available on Eucomed website

http://www.eucomed.be/press/downloads.aspx Under “Graphs and statistics” section.

Avg = 941Avg = 916

BelgiumGermany

ItalyFranceAustria

Western EuropeSweden

USAFinland

PortugalSpain

SwitzerlandDenmark

NetherlandsUK

NorwayIreland

0 200 400 600 800 1000 1200 1400

IPG CRT-P 2007 WE Average 2006 WE Average

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High Power Devices - Implants per Million Inh

The 2008 Preliminary data cannot to be shared, and has been replaced with the 2007 dataFinal implant rates for 2008 will be available on Eucomed website

http://www.eucomed.be/press/downloads.aspx Under “Graphs and statistics” section.

Avg = 189

Avg = 160

USAGermany

ItalyNetherlands

DenmarkAustria

Western EuropeIreland

BelgiumSwitzerland

FranceFinland

SwedenUK

NorwayPortugal

Spain

0 100 200 300 400 500 600 700

ICD CRT-D 2007 WE Average 2006 WE Average

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CRT Devices - Implants per Million Inh

Preliminary data, not to be distributed,Final implant rates will be available on Eucomed website

The 2008 Preliminary data cannot to be shared, and has been replaced with the 2007 dataFinal implant rates for 2008 will be available on Eucomed website

http://www.eucomed.be/press/downloads.aspx Under “Graphs and statistics” section.

Avg = 88Avg = 76

USAItaly

NetherlandsGermanyBelgium

DenmarkAustria

SwedenWestern Europe

FranceUK

SwitzerlandNorwayIrelandSpain

PortugalFinland

0 50 100 150 200 250 300

CRT-D CRT-P 2007 WE Average 2006 WE Average

7

0

10

20

30

40

50

60

Portugal Ita

lySpain

FranceGerm

any UKFinlandBelgiumDenmark

Netherlands

AustriaSweden

Switzerl

andIre

land

Norway

00.511.522.533.544.55

Based on 2007 CIA world factbook & Eucomed data 2007

GD

P pe

r per

son

$ 10

00 (P

PP)

Implants/G

DP (1000 $)

GDP

CRT+CRT-D Implant rates/GDP

Weak link between wealth and CRT implant rates

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SCD is a leading cause of death in Western Europe – more than stroke, AIDs, lung or breast cancer ~400.000 deaths/year1

Patients at risk are identified by the guidelines2

>85% of European indicated patients according to the ESC HF 2008 guidelines did not get a device3

ICD Implants

< 15% have access3

ICD Therapy in Western Europe:

Western Europe

1. Priori S.G. et al. Task Force on Sudden Cardiac Death, European Society of Cardiology – Summary of recommendations. Europace. 2002; 4: 3-182. HF2008 ESC Guidelines 3. Medtronic Data on File Jan 2008

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Western Europe

CRT Implants

< 25% have access4

Heart Failure is a major cause of death and hospitalizations in Europe1

Patients who benefit from CRT devices are identified by the guidelines2

The risk of being hospitalised for worsening HF is reduced by 52% by CRT3

>75% of European indicated patients according to the ESC HF 2008 guidelines did not get a device4

CRT Therapy in Western Europe

1. Priori S.G. et al. Task Force on Sudden Cardiac Death, EuropeanSociety of Cardiology – Summary of recommendations. Europace. 2002; 4: 3-182. HF 2008 ESC Guidelines3. Cleland. NEJM 2005;352: 1539-15494. Medtronic Data on File Jan 2008

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CRM Devices in Calendar Year 2008

Huge disparity between countries and also within countries

Patients treated during this year:

IPG: 127,586;

ICD (excl CRT-D): 18,119; CRT: 14,815

Growing at 8%

But untreated patients remain > 80%

Less than 15% ICD eligible patients received an ICD

Less than 25% CRT eligible patients received a CRT device.

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Out of Hospital Sudden Cardiac Arrest

Even out of hospital SCA patients may go untreated1

For Western Europe, this would mean:7,000 patients2 are•Admitted for SCA•Discharged without an ICD when they may

need it

1Sterk B et al, Europace. 2004 May;6(3):179-832 Calculated based on Sterk B et al, 5% National average survival – US, and Priori S.G. et al. Task Force on Sudden Cardiac Death, European Society of Cardiology –Summary of recommendations. Europace. 2002; 4: 3-18

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EHRA

Will EHRA play a role in reducing the number of untreated indicated patients in Europe?How can Eucomed help?

Thank you