Lumax 540 VR-T DX Unique protection 1 BIOTRONIK

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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®

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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. 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

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

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

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

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)

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)

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?

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]

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