Linoxsmart S DX Master Study

Final Results

Cardiac Rhythm Management

Tachyarrhythmia Therapy

November 2011

2

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)

Linoxsmart S DX Master Study

Study Objectives

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

Study Design

3

Linoxsmart S DX Master Study

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

Inclusion and Exclusion Criteria

4

Linoxsmart S DX Master Study

Primary endpoint

Rate of appropriate atrial sensing1 > 90%

Secondary endpoint

Linoxsmart S DX complication2-free rate >90%

Endpoints

1.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

2.Complication: Linox DX related adverse event with an additional invasive intervention

5

Linoxsmart S DX Master Study

Study Flow Chart

EnrollmentPatient Informed Consent

Implantation

Pre-Hospital-Discharge Follow-up12h - 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 enrollmentI 18%II 56%III 23%IV 3%

7

Linox smart S DX Master StudyAppropriate Atrial Sensing Rate

50

55

60

65

70

75

80

85

90

95

100

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

Ap

pro

pri

ate

Atr

ial S

en

sin

g [%

]

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

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

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Linoxsmart S DX Master Study Results

Secondary Endpoint - Safety

6 lead-related complications

4 lead repositionings

2 lead exchanges

Linoxsmart S DX complication-free rate: 94.8% [p=0.048]

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

Atrial Sensing Amplitude

Linoxsmart S DX Master Study Results

Linox smart S DX Master StudyMean P-wave Amplitude with Standard Deviation

0

1

2

3

4

5

6

7

8

9

10

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

P-w

av

e A

mp

lidu

te [

mV

]

14

Linoxsmart S DX Master Study Results

Ventricular Sensing Amplitude

Linox smart S DX Master StudyMean R-wave Amplitude with Standard Deviation

0

2

4

6

8

10

12

14

16

18

20

Implant PHD 1 month FU 3 month FU 6 month FU

R-w

av

e A

mplid

ute

[m

V]

15

Linoxsmart S DX Master Study Results

Ventricular Pacing Threshold

Linox smart S DX Master StudyMean Ventricular Pacing Threshold with Standard Deviation

0.0

0.5

1.0

1.5

2.0

I mplant PHD 1 month FU 3 month FU 6 month FU

Ve

ntr

icu

lar

pa

cin

g t

hre

sho

ld [

V]

16

Linoxsmart S DX Master Study Results

Ventricular Pacing Impedance

Linox smart S DX Master StudyMean Ventricular Pacing Impedance with Standard Deviation

0

200

400

600

800

1000

Implant PHD 1 month FU 3 month FU 6 month FU

Ve

ntr

icu

lar

pa

cin

g i

mp

ed

an

ce [

V]

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.

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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