1. Lumax 540 VR-T DX Unique protection 1 BIOTRONIK
Cardiac Rhythm Management
November 2011
Lumax 540 VR-T DX
Unique protection 1

2. 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

4. The world’s only single-chamber ICD system with complete atrial diagnostics
Lumax VR-T DX works with the specially designed Linoxsmart S DX ICD lead.
Atrial signals are sensed by the floating atrial dipole of the Linoxsmart S DX ICD lead
A modified atrial input stage of the Lumax 540 VR-T DX device amplifies the atrial signals.
The atrial information ensures accurate sensing and provides unique protection for single-chamber ICD patients.
The Lumax 540 VR-T DX ICD and the Linoxsmart S DX lead can be implanted like a standard single-chamber ICD system without any additional effort.

5. Lumax 540 VR-T DX
Unique premium single-chamber ICD with atrial sensing
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*
* RV 2.5 V/0.4 ms; 60 ppm; 700 Ω; RV 15 % pacing; 4 maximum energy shocks/year; Home Monitoring ON; diagnostics ON

6. Linoxsmart S DX High performance lead with proven reliability
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
7.8 F
0.28 mm
Cross section Linoxsmart S DX

7. Linoxsmart S DX High performance lead with proven reliability
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
Cross section Linoxsmart S DX
7.8 F
0.28 mm
150 / 170 mm

8. Linoxsmart S DX Master Study Results
Excellent Lead Handling
Linoxsmart S DX Master Study Results
Lead Implantation Assessment
87%
easy or very easy lead implantation due to proven ICD lead technology
n=116
* Linoxsmart S DX Master Study; data on file

9. Linoxsmart S DX Master Study Results
Excellent Electrical Performance
Linoxsmart S DX Master Study Results
(n=119) (n=116) (n=104) (n=101) (n=85)
(n=119) (n=113) (n=103) (n=101) (n=85)
* Linoxsmart S DX Master Study; data on file

10. Linoxsmart S DX Master Study Results
Excellent Electrical Performance
Linoxsmart S DX Master Study Results
(n=115) (n=120) (n=100) (n=100) (n=104)
(n=116) (n=120) (n=100) (n=100) (n=104)
* Linoxsmart S DX Master Study; data on file

11. Linoxsmart S DX Master Study Results
Excellent Electrical Performance
Linoxsmart S DX Master Study Results
Mean Atrial Sensing Amplitude
>5mV
mean atrial sensing amplitudes due to unique DX signal amplification
* Linoxsmart S DX Master Study; data on file

12. Linoxsmart S DX Master Study Results
Reliable Atrial Sensing
Linoxsmart S DX Master Study Results
Rate of appropriate atrial sensing
(primary endpoint)
93.8%
appropriate atrial sensing due to specially adapted DX input stage
* Linoxsmart S DX Master Study; data on file

13. The extended Lumax 540 Portfolio
Lumax 540 VR-T DX adds to the premium Lumax 540 Series
Lumax 540 VR-T
Lumax 540 DR-T
Lumax 540 HF-T
Lumax 540 VR-T DX
Linoxsmart S DX
Single-chamber ICD
Single-chamber ICD system with complete atrial diagnostics
Dual-chamber ICD
CRT-D

14. Agenda
Lumax 540 VR-T DX and Linoxsmart S DX
System description
Clinical Benefits

15. Lumax 540 VR-T DX and Linoxsmart S DX
The world’s only single-chamber ICD system with complete atrial diagnostics!
Compared to current standard single-chamber ICDs, Lumax DX enables unique patient protection by providing:
enhanced arrhythmia diagnosis with full featured 3-channel IEGM including RA, RV and far-field
safe shock reduction with clinically proven SMART Detection® algorithm
optimized AF management with complete atrial diagnostics and BIOTRONIK Home Monitoring®

16. Lumax 540 VR-T DX and Linoxsmart S DX
The world’s only single-chamber ICD system with complete atrial diagnostics!
enhanced arrhythmia diagnosis
safe shock reduction
optimized AF management

17. Conventional single-chamber ICD systems provide only ventricular rhythm information
In many cases ventricular electrogram alone does not allow accurate diagnosis at high level of confidence
VT or SVT ?
far-field
ventricle

18. enhanced
Unique DX single-chamber ICD system provides atrial AND ventricular rhythm information
The additional information on atrial rhythm give clear evidence about the origin of the tachycardia
far-field
atrium
ventricle

19. Additional atrial electrograms enable enhanced arrhythmia diagnosis
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.

20. Lumax 540 VR-T DX Clinical 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

21. Lumax 540 VR-T DX Clinical example
Detection of sudden onset arrhythmia on July 7, 2010
Far-field
Note: Show this slide and the next one to your customer and ask them what he/she thinks is the underlying arrhythmia, than proceed to the next two slides to show and discuss the solution
Atrium
Ventricle

22. Lumax 540 VR-T DX Clinical example
Termination of arrhythmia by ATP -> classification as VT correct?
Far-field
Note: Show this slide and the one before to your customer and ask them what he/she thinks is the underlying arrhythmia, than proceed to the next two slides to show and discuss the solution
Ventricle

23. Lumax 540 VR-T DX Clinical example
Start of AV node reentry tachycardia (July 7, 2010)
Far-field
Atrium
Ventricle

24. Lumax 540 VR-T DX Clinical example
Detection as VT
Delivered ATP terminated ongoing arrhythmia

25. Lumax 540 VR-T DX and Linoxsmart S DX
The world’s only single-chamber ICD system with complete atrial diagnostics!
enhanced arrhythmia diagnosis
safe shock reduction
optimized AF management

26. safe
Atrial 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

27. safe
Unique DX single-chamber ICD allows enhanced SVT discrimination for safe shock reduction
Clinically proven dual-chamber SMART Detection® algorithm provides enhanced SVT discrimination based on atrial and ventricular rhythm information
SMART Detection®
100% sensitivity
94% specificity
Available for VT1 and VT2 zone
Available for detection and redetection
Informative episode details
Traceable marker annotations
Detection SVT

28. Atrial and ventricular sensing for enhanced SVT discrimination
safe
Atrial 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

29. Atrial and ventricular sensing for enhanced SVT discrimination
safe
Atrial and ventricular sensing for enhanced SVT discrimination
IEGM-Online HD® transmission via BIOTRONIK Home Monitoring® allows timely remote evaluation of therapy appropriateness

30. Lumax 540 VR-T DX and Linoxsmart S DX
unique
Lumax 540 VR-T DX and Linoxsmart S DX
protection
The world’s only single-chamber ICD system with complete atrial diagnostics!
enhanced arrhythmia diagnosis
safe shock reduction
optimized AF management

31. of all ICD and pacemaker patients have previously unknown AF*
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
~25%
is the lifetime risk of developing AF in those who have reached the age of 40**
>13%
of all ICD and pacemaker patients have previously unknown AF*
* Ricci, RP. et al., Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation. Europace
** 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

32. 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
Detection AMon

33. Lumax 540 VR-T DX Clinical examples
Case 1: Early detection of AF
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

34. Lumax 540 VR-T DX Clinical examples
Case 1: Early detection of AF
Start of atrial fibrillation on July 12, 2010, 22:44h
Detection in AF monitoring zone

35. Lumax 540 VR-T DX Clinical examples
Case 1: Early detection of AF
IEGM reveals fast conduction into ventricle (up to 180 bpm)
Spontaneous termination on July 13, 2011, 12:52h (>14h duration)

36. Lumax 540 VR-T DX Clinical examples
Case 1: Early detection of AF
AF statistics reveals both slow and fast conduction into ventricle (up to 20% pacing during night, mean ven. heart up to 130 bpm)

37. 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
Anticoagulation necessary?
Risk for inappropriate therapy?
AF therapy effective?
Change of heart failure status?
In-office follow-up necessary?

38. 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
Evaluate AF
Change medication
Monitor therapy success
Atrial Burden
[% of day]

39. Lumax 540 VR-T DX and Linoxsmart S DX
unique
Lumax 540 VR-T DX and Linoxsmart S DX
protection
The world’s only single-chamber ICD system with complete atrial diagnostics!
enhanced arrhythmia diagnosis
safe shock reduction
optimized AF management