Linoxsmart S DX Master Study Cardiac Rhythm Management Tachyarrhythmia Therapy November 2011 Linoxsmart S DX Master Study Final Results 1

Linoxsmart S DX Master Study Study Objectives Proof of safety and efficacy of the Linoxsmart S DX ICD lead Regulatory support for the approval processes in USA, Japan, Australia and other countries (Master Study) Study Design 119 patients Study start: March 15, 2010 Prospective, non-randomized, international Included system components: Linoxsmart S DX Lumax 540 VR-T DX Cardiomessenger II/II-S

Linoxsmart S DX Master Study Inclusion and Exclusion Criteria Inclusion Meet the indications for an ICD therapy The patient will be available for the follow-up visits Exclusion The patient does not meet ICD therapy indications The patient has permanent atrial tachyarrhythmia The patient has a life expectancy of less than six month The patient is younger than 18 years The patient is expected to have cardiac surgery in the next six months The patient is enrolled in another cardiac clinical study

Linoxsmart S DX Master Study Endpoints Primary endpoint Rate of appropriate atrial sensing1 > 90% Secondary endpoint Linoxsmart S DX complication2-free rate >90% Appropriate atrial sensing: Assessment of 10 consecutive intrinsic atrial beats documented with markers at PHD and 1,3, and 6 month follow-up in dorsal lying position Complication: Linox DX related adverse event with an additional invasive intervention

Linoxsmart S DX Master Study Study Flow Chart Enrollment Patient Informed Consent Implantation Pre-Hospital-Discharge Follow-up 12h - 10 days p.o. 1 Month Follow-up (±1 week) 3 Month Follow-up (±2 weeks) 6 Month Follow-up (±4 weeks) Study End

Linoxsmart S DX Master Study Results Study Centers and Patient Demographics Study centers 25 clinics in 7 countries 45 implanters Patients 116 patients (84% male) Age: 60±14 years Primary prevention indication: 73.3% 20 patients with history of AF LVEF: 36±15 % NYHA classification at enrollment I 18% II 56% III 23% IV 3%

Linoxsmart S DX Master Study Results Primary Endpoint - Efficacy Rate of appropriate atrial sensing: 93.8% [p=0.005] Required rate of appropriate atrial sensing to confirm alternative hypothesis HA

Linoxsmart S DX Master Study Results Secondary Endpoint - Safety Linoxsmart S DX complication-free rate: 94.8% [p=0.048] 6 lead-related complications 4 lead repositionings 2 lead exchanges

Linoxsmart S DX Master Study Results Lead Implantation Assessment Excellent handling characteristics of the new Linoxsmart S DX lead: Over 87% of implantation procedures have been assessed as either very easy or easy

Linoxsmart S DX Master Study Results Lead Implantation Technique

Linoxsmart S DX Master Study Results Lead Insertion Site

Linoxsmart S DX Master Study Results Lead Tip Position

Linoxsmart S DX Master Study Results Atrial Sensing Amplitude

Linoxsmart S DX Master Study Results Ventricular Sensing Amplitude

Linoxsmart S DX Master Study Results Ventricular Pacing Threshold

Linoxsmart S DX Master Study Results Ventricular Pacing Impedance

Linoxsmart S DX Master Study Results Patients with Atrial Tachycardia Number of Patients AF history at enrollment 20 (17.2%) AF appropriately detected during follow-up period in patients with no AF history at enrollment 11 (9.5%) Other atrial tachycardia detected during follow-up period in patients with no AF history at enrollment 2 (1.7%) Total 33 (28.4%) Advanced AF diagnosis with Lumax DX - out of 96 patients with no history of AF at enrollment 11 patients had been diagnosed to have one ore more AF episodes already within 6-month follow-up period of the study.

Linoxsmart S DX Master Study Results Summary Within the Linoxsmart S DX Master Study the investigated DX system demonstrated an appropriate atrial sensing rate of 93.8% a complication-free rate of 94.8% a handling assessment of either very easy or easy in >87% of the implantation procedures stable p-wave amplitudes with a mean value of about 5mV at different body position at every visit appropriate AF detection for the first time in 11 patients with no history of AF at enrollment