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

2. 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

3. 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

4. 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

5. 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

6. 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%

7. 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

8. 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

9. 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

10. Linoxsmart S DX Master Study Results
Lead Implantation Technique

11. Linoxsmart S DX Master Study Results
Lead Insertion Site

12. Linoxsmart S DX Master Study Results
Lead Tip Position

13. Linoxsmart S DX Master Study Results
Atrial Sensing Amplitude

14. Linoxsmart S DX Master Study Results
Ventricular Sensing Amplitude

15. Linoxsmart S DX Master Study Results
Ventricular Pacing Threshold

16. Linoxsmart S DX Master Study Results
Ventricular Pacing Impedance

17. 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.

18. 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