Integrated Therapy Warren Klibbe Marketing Manager CRM

The Philos II pacemaker family Philos II S has also the CE Mark, but will not be produced 2

Philos II overview Auto-Initialization Implantation IRSplus Active capture control (ACC) Therapy Mode switching overdrive pacing Effective & efficient workflow Rate fading Broadband IEGM recordings Follow-up Follow-up Home Monitoring 3

Implant confirmation time Auto-initialisation Implant confirmation time 30 min Lead detection polarity selection Diagnostic memory Mode switching PMT management Function activation Threshold monitoring 4

Active capture control Maximum safety 104 patients, 41 Holters, FDA No pauses 100% capture with backup pulse 1 year lifetime extension* No explicit lead limitation Works in uni & bipolar configuration *Calculated using a mean V amplitude reduction of 2.0 V 5

Easy and efficient use – active capture control Intelligent details deliver superiority Fusion discrimination reduces ventricular pacing Back-up pulse with increased width offers protection from phrenic nerve stimulation assuring maximum energy efficacy Single button activation 6

Active capture control 3 components of ACC algorithm ACC at each periodically periodically pace Active threshold monitoring ATM Signal-analysis Threshold search Adjust-ment of the pacing amplitude Capture control successful successful 7

Active capture control Signal check Determinates whether evoked response and polarization artifact are acceptable Pacing with capture Pacing without capture Polarisation- artefact Polarisation- artefact Evoked response 8

Active capture control Signal analysis In the first 5 paces - analysis of the evoked response together with polarisation artefact In the second step, 2 coupled paces (100 ms interval) are applied for five cycles. Based on the in-effective second pace, the maximum polarisation artefact can be determined 9

Active capture control (ACC) Automatic threshold measurement The ventricular threshold is measured periodically and the stimulation amplitude is adapted The measurement starts with the programmed “maximum amplitude“ Output amplitudes are reduced in larger decriments at the beginning, and finally in smaller steps. Each decrimented amplitude has 2 pulses. A back-up pace with higher energy is delivered in the event of NO capture If non-capture is still indicated with a pacing amplitude of 0.1 Volt, than the threshold-test is declareded as “not succesful“ 10

Active capture control Automatic threshold measurement Back-up Pules 0.8 V @ 1.0 ms Example Maximum ACC amplitude = 2.4 V Safety margin = 0.5 V Threshold = 0.9 V 2.4 V 2.1 V 1.8 V 1.6 V 1.4 V 1.2 V 1.0 V 0.9 V 0.8 V 1.4 V 11

Active capture control Amplitude steps during threshold measurement ... 17 0.9 16 1.0 15 1.1 14 1.3 13 1.5 12 1.7 1.2 11 1.9 1.4 10 2.2 1.6 9 2.5 1.8 8 2.9 2.1 7 3.3 2.4 6 3.8 2.8 5 4.3 3.2 4 4.9 3.7 2.7 3 5.6 4.2 3.1 2 6.4 4.8 3.6 1 Amplitude Steps (if capture is not lost during test) Maximum ACC Amplitude Note: below 1.0 V the step is always 0.1V 12

Active capture control Continuous capture confirmation Continuous beat-by-beat testing to ensure effective pacing In case of no capture:  Back-up pace with increased energy In case of loss of capture (a sequence of non-capture):  Start of a new threshold measurement 13

Active capture control The back-up pulse Detection of evoked response 60 ms Ventricular blanking 20 ms Calculation, programming 50 ms 131 ms Ventricular pace actual amplitude with 0.4 ms non-capture Back-up pace actual amplitude with 1.0 ms capture 14

Active capture control Automatic, periodic measurement of ventricular pacing threshold Beat-by-beat capture confirmation Back-up pulse upon detection of non-capture Automatic reprogramming of pulse amplitude Comprehensive diagnostics 15

Active capture control Available statistics for ACC 16

Follow up: Automatic threshold test Fast and automatic determination of the ventricular threshold 100% security due to effective backup pacing assuring ventricular support 17

Active capture control Programming 18

FDA feasibility trial Philos II ACC 19

Broadband IEGM recording Storage of up to 12 IEGM recordings Recording of unfiltered atrial and ventricular IEGM’s and marker channel Recording of 7.5 seconds before and 2.5 seconds after the trigger Broadband signal resolution: 128 Hz 20

Broadband IEGM recording No marker signal correlation Reduced specificity of mode switching due to intermittent farfield sensing 21

Automatic IEGM recordings Intelligent memory management Examples First Mode Switching event Mode Switching event with the highest ventricular rate Episode with the longest duration of mode switching Event with the highest ventricular rate Episode with the longest duration of a high ventricular rate 1 2 3 4 5 12 event memories (of approx 10 seconds each) Intelligent memory management, NOT “First-In First-Out“ Clinically relevant events are not overwritten 22

Broadband IEGM recording Appropriate mode switch due to AF Optimal correlation: marker and event 23

AT/AES classification P-P interval A V Prematurity (e.g., 25%) AVI AARP AESW Information about the origin and classification of AT Therapy verification Possibility to verify antitachycardia therapies 24

Follow-up Storage of follow-up data in the pacemaker 25

Home Monitoring Home Monitoring principle 1. Patient has an implant with Home Monitoring option 2. CardioMessenger relays on daily basis an SMS (and additional messages if needed) 4. Physician with a secured internet entry 3. Automatic data analysis in the service center 26

Home Monitoring The antenna 27

Rate Fading (Rate smoothing) Purpose of rate fading Prevention of an in-appropriate rate decrease: For example, in patients with exercise induced bradycardia After mode-switching Prevention of symptoms related to sudden rate drop 28

Rate fading Terminology Back-up rate: Effective pacing rate Target rate: Calculated rate (mean detected rate) RF-increase: Speed of adaptation of the back-up rate towards a higher target rate RF-decrease: Speed of adaptation of the back-up rate towards a lower target rate 29

Rate fading Rate fading at sudden rate drop of intrinsic heart rate 10 bpm 30

Rate fading Intrinsic Rate Target Rate Back-up Rate Basic Rate Increasing the Back-up Rate for 2 bpm / cycle (example) Reduction of the Back-up Rate for 0,5 bpm/cycle (example) 10 ppm Basic Rate 4 Cycles Time 31

Rate fading Programming 32

Mode switching with 2:1 lock-in protection The goal of mode switching: Provides transition of atrial tachycardias to the ventricle The goal of 2:1 Lock-In protection: Ensures adequate mode switching even in difficult situations, e.g. long blanking and “slow“ tachycardias 33

Mode switching with 2:1 lock-in protection When does 2:1 Lock-In occur? A long blanking interval (>125ms) was programmed in the pacemaker The patient suffers of atrial flutter 34

Mode switching with 2:1 lock-in protection Ars Blanking As Vp Ars Blanking As Vp Example: Atrial flutter 240bpm, TARP 425 ms, PVAB 200 ms The pacemaker ignores every second P wave, because it occures in the blanking. The sensed rate is 120bpm. TARP Blanking 35

Mode switching with 2:1 lock-in protection Programming and 36

Event below the intervention rate Mode switching with 2:1 lock-in protection Desynchronisation Resynchronisation ... DDD(R) DDI(R) DDI(R) DDD(R) ... ... 1 out of 8 0 out of 8 ... 0 out of 8 2 out of 8 0 out of 8 0 out of 8 1 out of 8 0 out of 8 ... out of 8 1 out of 8 ... 3 out of 8 ... 5 out of 8 4 out of 8 Example: X=5 (3-8) Example: Z=5 (3-8) Event above the intervention rate Event below the intervention rate During ERI mode switching is not disabled. 37

Mode switching with 2:1 lock-in protection Termination of 2:1 lock-in by mode switching Beginning of atrial flutter with 250 ppm. Philos II is in the 2:1 Lock-in . Beginning of the suspicion phases. AV delay extention uncovers 2:1 Lock-in. Termination by immediate Mode Switching Sinus-rhythm 2. P wave 1. P wave 38

VES lock-in protection What is VES-lock-in? It may occur that spontaneous P waves are sensed in the refractory period As a consequence of this … The following QRS-complex is classified as a VES P waves will not be tracked AV synchrony is lost Mainly patients with first/second degree AV-block are affected Who is affected? 39

VES lock-in protection Description of VES-lock-in Creates the picture of atrial undersensing despite the presence of ( intracardiac ) P waves larger then the programmed atrial sensitivity May only occur during episodes of spontaneously conducted P waves with somewhat longer PR times In literature also referred to as “Functional atrial undersensing” 40

VES lock-in protection VES-lock-in timing As Ars Ars Vs („VES“) Vs („VES“) Vs (VES) Vp ARP Basic Interval ARP Extention 41

VES lock-in protection The algorithm Monitoring of Ars-VES sequences Detection if programmed number (n= 4, 6 or 12) of Ars-VES cycles occur Termination of the lock-in situation by an atrial pace, triggered by the atrial refractory sense (Ars) VES lock-in protection restores AV synchrony 42

... VES lock-in protection VES-lock-in termination ... „n“ cycles ARP Ars Ars Ap As Vs („VES“) Vp Vp ... ... „n“ cycles ARP Basic interval ARP extention 43

VES lock-in protection Programming Factory and standard setting = Off Ves-lock-in protection = ON Programmable number of termination cycles: 4, 6, 12 44

VES lock-in protection Vs (VES) Ars Ars Ap Vp As 45

VES lock-in protection Statistics VES-lock-in terminations counter in the „special events“ window 46

VES lock-in protection Competitors VES-lock-in protection is a unique function Competitors do not provide a similar algorithm BUT VES-lock-in behaviour has been reported at competitor pacemakers: Pacesetter1,2 Vitatron1 Medtronic1 Biotronik1 1) Bode et al., PACE 1999 2) Barold, PACE 1999 Many of the terms sound similar but should not be confused. 47

Thank you for your kind attention! Philos II offers you Convenience during implantation Multiple effective therapy options Conclusive diagnostics Efficient follow-up 48

Thank you for your attention!