BIOTRONIK Cardiac Rhythm Management November 2011 Lumax 540 VR-T DX Unique protection.

BIOTRONIK

Cardiac Rhythm Management

November 2011

Lumax 540 VR-T DX

Unique protection

Agenda

Lumax 540 VR-T DX and Linoxsmart S DX

System description

Clinical Benefits

3

The world’s only single-chamber ICD system with complete atrial diagnostics

5

Lumax 540 VR-T DX

Additional atrial sensing channel optimized for use with floating sensing electrodes

3-channel IEGM incl. RA, RV and far-field

SMART Detection®

Complete AF and HF diagnostics

BIOTRONIK Home Monitoring®

9.4 years longevity*

Unique premium single-chamber ICD with atrial sensing

* RV 2.5 V/0.4 ms; 60 ppm; 700 Ω; RV 15 % pacing; 4 maximum energy shocks/year; Home Monitoring ON; diagnostics ON

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Linoxsmart S DX

Pentapolar 7.8 F single coil ICD lead with active fixation

Floating dipole for atrial sensing

Easy handling, no special implant technique

Based on proven Linoxsmart ICD Lead family

High performance lead with proven reliability

7.8 F

0.28 mm

Cross section Linoxsmart S DX

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Linoxsmart S DX Master Study Results

easy or very easy lead implantation

due to proven ICD lead technology

87%

Excellent Lead Handling

Lead Implantation Assessment

49%

38%

10%3%

very easy

easy

moderate difficult

difficult

very easy

easy

moderate difficult

difficult

n=116

* Linoxsmart S DX Master Study; data on file

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0

1

2

3

4

5

6

7

8

9

10

I mplant PHD 1-monthFU

3-monthFU

6-monthFU

P-w

av

e A

mp

lidu

te [

mV

]


mean atrial sensing amplitudes

due to unique DX signal amplification

>5mV

Excellent Electrical Performance

Mean Atrial Sensing Amplitude


12

50

60

70

80

90

100

PHD 1-month FU 3-month FU 6-month FU

App

ropr

iate

Atr

ial S

ensi

ng [%

]

Dorsal lying position Sitting, palms together Sitting, Jendrassik's m.


Rate of appropriate atrial sensing (primary endpoint)

appropriate atrial sensing

due to specially adapted DX input stage

93.8%

Reliable Atrial Sensing


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Single-chamber ICD system with complete atrial

diagnostics

The extended Lumax 540 Portfolio

Lumax 540 VR-T DXLinoxsmart S DX

Single-chamber ICD

Lumax 540 VR-TDual-chamber ICD CRT-D

Lumax 540 DR-T Lumax 540 HF-T

Lumax 540 VR-T DX adds to the premium Lumax 540 Series

Agenda


System description

Clinical Benefits

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safe shock reduction

optimized AF management

enhanced arrhythmia diagnosis


The world’s only single-chamber ICD system with complete atrial diagnostics!

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In many cases ventricular electrogram alone does not allow accurate diagnosis at high level of confidence

VT or

SVT ?

Conventional single-chamber ICD systems provide only ventricular rhythm information

ventricle

far-field

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The additional information on atrial rhythm give clear evidence about the origin of the tachycardia

enhancedUnique DX single-chamber ICD system provides atrial AND ventricular rhythm information

ventricle

far-field

atrium

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Availability of atrial electrograms in addition to ventricular electrograms significantly improves accuracy of arrhythmia diagnosis

Diagnostic accuracy with single versus dual chamber electrograms*

* Kim, MH. et al., Diagnostic value of single versus dual chamber electrograms recorded from an implantable defibrillator. J.Interv.Card Electrophysiol. 9 (1):49-53, 2003.

Additional atrial electrograms enable enhanced arrhythmia diagnosis

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Lumax 540 VR-T DXClinical example

73 year old male

Secondary prevention, no history of AF

CAD, hypertension, diabetes mellitus

EF 47%, NYHA II

Lumax 540 VR-T DX with Linoxsmart 65/17 S DX implanted on April 01, 2010

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Detection of sudden onset arrhythmia on July 7, 2010

Far-field

Atrium

Ventricle

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Far-field

Ventricle

Termination of arrhythmia by ATP -> classification as VT correct?

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Start of AV node reentry tachycardia (July 7, 2010)

Far-field

Atrium

Ventricle

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Detection as VT

Delivered ATP terminated ongoing arrhythmia

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safeAtrial arrhythmias increase the risk for ICD patients to receive inappropriate shocks

76% of inappropriate shocks are caused by AF and SVT (MADIT II)*

* Daubert, JP et al., Inappropriate implantable cardioverter-defibrillator shocks in MADIT II, JACC 2008, 51: 1357–65

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safe

Clinically proven dual-chamber SMART Detection® algorithm provides enhanced SVT discrimination based on atrial and ventricular rhythm information

Det

ectio

n S

VT

SMART Detection®

100% sensitivity

94% specificity

Available for VT1 and VT2 zone

Available for detection andredetection

Informative episode details

Traceable marker annotations

Unique DX single-chamber ICD allows enhanced SVT discrimination for safe shock reduction

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safeAtrial and ventricular sensing for enhanced SVT discrimination

SMART Detection® correctly identifies atrial arrhythmia and withholds inappropriate therapy

SMART episode details

Duration: 1 min 17 sec

Classification: SVT

Measured onset: 58%,

Measured stability: 2%

Delivered ATP: 0

Delivered shocks: 0

SMART details: Aflut

PP<RR,

RR stable,

N:1 multiplicity

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safeAtrial and ventricular sensing for enhanced SVT discrimination

IEGM-Online HD® transmission via BIOTRONIK Home Monitoring® allows timely remote evaluation of therapy appropriateness

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uniqueprotection



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>13%of all ICD and

pacemaker patients have previously

unknown AF*

~25%is the lifetime risk of

developing AF in those who have reached the

age of 40**

Atrial fibrillation is most common arrhythmia with high incidence in cardiac device patients

Many cardiac device patients without history of atrial fibrillation show new or yet undiagnosed AF after implantation

* Ricci, RP. et al., Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation. Europace. 2009.

** Camm, AJ. et al., Guidelines for the management of AF: the Task Force for the Management of AF of the European Society of Cardiology (ESC). Europace. 2010

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optimized Early detection of atrial fibrillation allows reduction of associated risks

With AF monitoring zone and IEGM-Online HD® the unique Lumax DX enables early detection of silent AF in a single-chamber ICD system

Det

ectio

n A

Mon

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Lumax 540 VR-T DXClinical examples

47 years old female

Prophylactic indication

Hypertrophic obstructive cardiomyopathy

EF 60%, NYHA II, no history of AF

Lumax 540 VR-T DX with Linoxsmart S DX 65/17 implanted on June 4, 2010

R amplitude ~12mV, P amplitudes between 2-5 mV

Case 1: Early detection of AF

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Start of atrial fibrillation on July 12, 2010, 22:44h

Detection in AF monitoring zone


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IEGM reveals fast conduction into ventricle (up to 180 bpm)

Spontaneous termination on July 13, 2011, 12:52h (>14h duration)


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AF statistics reveals both slow and fast conduction into ventricle (up to 20% pacing during night, mean ven. heart up to 130 bpm)


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Anticoagulation necessary?

Risk for inappropriate therapy?

AF therapy effective?

Change of heart failure status?

In-office follow-up necessary?

optimized Lumax DX provide complete AF and HF diagnostics in a single-chamber ICD

Automatic transmission of relevant diagnostic data via BIOTRONIK Home Monitoring® allows immediate and remote assessment of clinical implications

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Monitor therapy successEvaluate AF

Change medication

Lumax DX and BIOTRONIK Home Monitoring® enable optimized AF management

Daily data transmission of complete AF diagnostics via BIOTRONIK Home Monitoring® allows remote monitoring of therapy success

Atrial Burden[% of day]

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uniqueprotection



BIOTRONIK Cardiac Rhythm Management November 2011 Lumax 540 VR-T DX Unique protection.

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