Download PATIENTS THAT MAY BENEFIT

Over 200,000 patients worldwide are estimated to receive
a CRT device each year. However, limitations prevent some
patients from benefiting.
CHALLENGING
PROCEDURE
5%
30%
10%
23%
of patients fail to have coronary sinus (CS) lead
implanted in a single procedure1,2,3
UP TO
EFFICACY RATE
of patients who receive a CRT device don’t benefit
from treatment4,5,6
UP TO
POST IMPLANT
COMPLICATIONS
EBR Systems, Inc.
686 W. Maude Ave., Suite 102
Sunnyvale, CA 94085 USA
of patients experience CS lead complications including
lead dislodgements and phrenic nerve stimulation1,2,7,8,9
www.ebrsystemsinc.com
UP TO
UPGRADES
UP TO
of patients who receive a CRT device already have a
conventional pacemaker or ICD implanted10. Studies
© 2016 EBR Systems, Inc. All Rights Reserved.
WiSE is a trademark of EBR Systems, Inc.
Caution: Not commercially available in the United States
demonstrated a higher risk (18.7%) of developing major
complications during an upgrade to a CRT system11.
PATIENTS THAT MAY BENEFIT
 Patients who have not
responded to CRT
 Patients with an acute or chronic
CS lead issue
 Patients with known risk
associated with a CRT upgrade
1.Leon AR, Abraham WT, Curtis AB, et al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart
Failure: Combined Results of Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: 2348–56.
2.Gras D, Bocker D et al. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety”
Europace (2007) 9, 516–522.
3.Al-Majed NS, McAlister FA, Bakal JA, Ezekowitz JA. Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart
failure. Ann Intern Med 2011;154:401–412
4.Martin DO, Lemke B, et al., Investigation of a novel algorithm for synchronized left ventricular pacing and ambulatory optimization of
cardiac resynchronization therapy: Results of the adaptive CRT trial. HRS 2012 Volume 9, Issue 11, Pages 1807–1814.e1.
5.Chung ES, Leon AR, et al., Results of the Predictors of Response to CRT (PROSPECT) Trial. Circulation. 2008;117: 2608-2616.
6.McAlister FA, Ezekowitz J, Hooton, N, et al. Cardiac Resynchronization Therapy for Patients with Left Ventricular Systolic Dysfunction: A
Systematic Review. JAMA. 2007; 297(22): 2502-14.
7.Abraham WT, Fisher WG, Smith AL, et al. Cardiac Resynchronization in Chronic Heart Failure. N Engl J Med. 2002; 346: 1845-53.
8.Linde C, Abraham WT, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in
Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, 2008.
9.Tang SL, Wells GA, et al. Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure. NEJM 2010;363:2385-95.
10.Brignole M, Auricchio A, et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. European Heart Journal (2013)
34, 2281–2329.
11.Poole JE, Gleva MJ, et al. Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements
and Upgrade Procedures Results From the REPLACE Registry. Circulation. 2010;122:1553-1561.
12.van Deursen C, van Geldorp I, Rademakers L. et al. Left Ventricular Endocardial Pacing Improves Resynchronization Therapy in Canine Left
Bundle-Branch Hearts. Circ Arrhythmia Electrophysiol. 2009; 2: 580-7.
13.Bracke FA, van Gelder BM, Dekker LRC, Woorst JF, Teijink JA. Left Ventricular Endocardial Pacing in Cardiac Resynchronization Therapy: Moving
from Bench to Bedside. Neth Heart J. 2012; 20(3): 118–24.
14.Reddy VY, et al. Abstract LBCT01-05. Wireless LV Endocardial Stimulation for CRT: Primary Results of the Safety and Performance of
Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015;
Boston, Massachusetts.
15.Reddy VY, Neuzil P, et al. Presentation of Wireless LV Endocardial Stimulation for CRT: Primary Results of the Safety and Performance of
Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015;
Boston, Massachusetts.
16.Leon AR, Abraham WT, Curtis AB, et al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart
Failure: Combined Results of Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: 2348–56.
17.Linde C, Abraham WT, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in
Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, 2008.
18.Young JB, Abraham WT, et al. Combined Cardiac Resynchronization and Implantable Cardioversion Defibrillation in Advanced Chronic Heart
Failure, The MIRACLE ICD Trial. JAMA. 2003;289(20):2685-2694.
W I R E L E S S LV
E N D O C A R D I A L PAC I N G
MC-03195 Rev. A
New Hope
for
Heart Failure
CRT Patients
Caution: Not commercially available in the United States
CLINICAL
RESULTS
HOW
IT WORKS
97%
The WiSE CRT System is designed to overcome the limitations of traditional CRT
pacing. It provides wireless, left ventricular (LV), endocardial pacing in patients
with issues related to standard epicardial coronary sinus (CS) pacing leads.
PACES
CO-IMPLANT
DEVICE
97%
of patients achieved
implantation success
(N=35)
of patients who failed
conventional CRT achieved cardiac
resynchronization at 1-month (N=34)
Receiver Electrode
paces by converting the
ultrasound energy
3
WIRELESS
into electrical energy
LV EF%
Baseline and 6m
50
250
2
ENDOCARDIAL
139
171
150
120
2
1.8
131
1
141
Baseline
100
6m
Select-LV: 69.5% pts ≥ 5% increase (N=23)
14, 15
Baseline
80
6m
Baseline
0
6m
SELECT-LV: QRS decrease of 53 ms
(184 to 131 ms or 29% reduction, N=23)14, 15
Select-LV: 64.7% pts ≥
15% improvement in LVESV (N=17)14, 15
Baseline
6m
SELECT-LV: 61.5% pts ≥ 1 class
improvement in functional capability (N=26)14, 15
Transmitter
transmits ultrasound
energy to the
More Physiological Pacing
Receiver Electrode
RECEIVER
ELECTRODE
Stimulates from the inside of the left
ventricle. Endocardial pacing is considered
more physiological – delivering improved
electrical and haemodynamic response.12,13,14
1
LENGTH OF BODY 9.1mm
DETECTS
The SELECT-LV study showed sustained cardiovascular
improvement for complex CRT patients treated with
the WiSE System
Composite Global Score
(Mortality, HF Hosp, NYHA, QOL)
Transmitter
DIAMETER 2.7mm
detects the RV pacing
pulse from
BATTERY
the co-implant
LV site selection of the stimulation
location; designed to enable tailored
therapy to meet individual patient needs.
3
2.6
27.0
10
BiV
168
160
33.7
30
TRANSMITS
Intrinsic
184
20
Freedom in LV Positioning
4
RV only
200
Designed to eliminate lead complications.
NYHA
Baseline and 6m
200
40
Leadless LV Stimulation
CUSTOMIZED
QRS Duration
Baseline to 6m
End Systolic Volume
Baseline and 6m
TRANSMITTER
All in as
little as
2
milliseconds!
81%
of patients experienced
persistent clinical
benefits at 6-months
(N=24)
Select-LV14, 15
Prospect5
Miracle16
Reverse17
Worsened
Unchanged
Improved
Miracle-ICD18
0
10
20
30
40
50
60
70
80
90
Over 200,000 patients worldwide are estimated to receive
a CRT device each year. However, limitations prevent some
patients from benefiting.
CHALLENGING
PROCEDURE
5%
30%
10%
23%
of patients fail to have coronary sinus (CS) lead
implanted in a single procedure1,2,3
UP TO
EFFICACY RATE
of patients who receive a CRT device don’t benefit
from treatment4,5,6
UP TO
POST IMPLANT
COMPLICATIONS
EBR Systems, Inc.
686 W. Maude Ave., Suite 102
Sunnyvale, CA 94085 USA
of patients experience CS lead complications including
lead dislodgements and phrenic nerve stimulation1,2,7,8,9
www.ebrsystemsinc.com
UP TO
UPGRADES
UP TO
of patients who receive a CRT device already have a
conventional pacemaker or ICD implanted10. Studies
© 2016 EBR Systems, Inc. All Rights Reserved.
WiSE is a trademark of EBR Systems, Inc.
Caution: Not commercially available in the United States
demonstrated a higher risk (18.7%) of developing major
complications during an upgrade to a CRT system11.
PATIENTS THAT MAY BENEFIT
 Patients who have not
responded to CRT
 Patients with an acute or chronic
CS lead issue
 Patients with known risk
associated with a CRT upgrade
1.Leon AR, Abraham WT, Curtis AB, et al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart
Failure: Combined Results of Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: 2348–56.
2.Gras D, Bocker D et al. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety”
Europace (2007) 9, 516–522.
3.Al-Majed NS, McAlister FA, Bakal JA, Ezekowitz JA. Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart
failure. Ann Intern Med 2011;154:401–412
4.Martin DO, Lemke B, et al., Investigation of a novel algorithm for synchronized left ventricular pacing and ambulatory optimization of
cardiac resynchronization therapy: Results of the adaptive CRT trial. HRS 2012 Volume 9, Issue 11, Pages 1807–1814.e1.
5.Chung ES, Leon AR, et al., Results of the Predictors of Response to CRT (PROSPECT) Trial. Circulation. 2008;117: 2608-2616.
6.McAlister FA, Ezekowitz J, Hooton, N, et al. Cardiac Resynchronization Therapy for Patients with Left Ventricular Systolic Dysfunction: A
Systematic Review. JAMA. 2007; 297(22): 2502-14.
7.Abraham WT, Fisher WG, Smith AL, et al. Cardiac Resynchronization in Chronic Heart Failure. N Engl J Med. 2002; 346: 1845-53.
8.Linde C, Abraham WT, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in
Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, 2008.
9.Tang SL, Wells GA, et al. Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure. NEJM 2010;363:2385-95.
10.Brignole M, Auricchio A, et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. European Heart Journal (2013)
34, 2281–2329.
11.Poole JE, Gleva MJ, et al. Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements
and Upgrade Procedures Results From the REPLACE Registry. Circulation. 2010;122:1553-1561.
12.van Deursen C, van Geldorp I, Rademakers L. et al. Left Ventricular Endocardial Pacing Improves Resynchronization Therapy in Canine Left
Bundle-Branch Hearts. Circ Arrhythmia Electrophysiol. 2009; 2: 580-7.
13.Bracke FA, van Gelder BM, Dekker LRC, Woorst JF, Teijink JA. Left Ventricular Endocardial Pacing in Cardiac Resynchronization Therapy: Moving
from Bench to Bedside. Neth Heart J. 2012; 20(3): 118–24.
14.Reddy VY, et al. Abstract LBCT01-05. Wireless LV Endocardial Stimulation for CRT: Primary Results of the Safety and Performance of
Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015;
Boston, Massachusetts.
15.Reddy VY, Neuzil P, et al. Presentation of Wireless LV Endocardial Stimulation for CRT: Primary Results of the Safety and Performance of
Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015;
Boston, Massachusetts.
16.Leon AR, Abraham WT, Curtis AB, et al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart
Failure: Combined Results of Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: 2348–56.
17.Linde C, Abraham WT, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in
Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, 2008.
18.Young JB, Abraham WT, et al. Combined Cardiac Resynchronization and Implantable Cardioversion Defibrillation in Advanced Chronic Heart
Failure, The MIRACLE ICD Trial. JAMA. 2003;289(20):2685-2694.
W I R E L E S S LV
E N D O C A R D I A L PAC I N G
MC-03195 Rev. A
New Hope
for
Heart Failure
CRT Patients
Caution: Not commercially available in the United States
Over 200,000 patients worldwide are estimated to receive
a CRT device each year. However, limitations prevent some
patients from benefiting.
CHALLENGING
PROCEDURE
5%
30%
10%
23%
of patients fail to have coronary sinus (CS) lead
implanted in a single procedure1,2,3
UP TO
EFFICACY RATE
of patients who receive a CRT device don’t benefit
from treatment4,5,6
UP TO
POST IMPLANT
COMPLICATIONS
EBR Systems, Inc.
686 W. Maude Ave., Suite 102
Sunnyvale, CA 94085 USA
of patients experience CS lead complications including
lead dislodgements and phrenic nerve stimulation1,2,7,8,9
www.ebrsystemsinc.com
UP TO
UPGRADES
UP TO
of patients who receive a CRT device already have a
conventional pacemaker or ICD implanted10. Studies
© 2016 EBR Systems, Inc. All Rights Reserved.
WiSE is a trademark of EBR Systems, Inc.
Caution: Not commercially available in the United States
demonstrated a higher risk (18.7%) of developing major
complications during an upgrade to a CRT system11.
PATIENTS THAT MAY BENEFIT
 Patients who have not
responded to CRT
 Patients with an acute or chronic
CS lead issue
 Patients with known risk
associated with a CRT upgrade
1.Leon AR, Abraham WT, Curtis AB, et al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart
Failure: Combined Results of Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: 2348–56.
2.Gras D, Bocker D et al. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety”
Europace (2007) 9, 516–522.
3.Al-Majed NS, McAlister FA, Bakal JA, Ezekowitz JA. Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart
failure. Ann Intern Med 2011;154:401–412
4.Martin DO, Lemke B, et al., Investigation of a novel algorithm for synchronized left ventricular pacing and ambulatory optimization of
cardiac resynchronization therapy: Results of the adaptive CRT trial. HRS 2012 Volume 9, Issue 11, Pages 1807–1814.e1.
5.Chung ES, Leon AR, et al., Results of the Predictors of Response to CRT (PROSPECT) Trial. Circulation. 2008;117: 2608-2616.
6.McAlister FA, Ezekowitz J, Hooton, N, et al. Cardiac Resynchronization Therapy for Patients with Left Ventricular Systolic Dysfunction: A
Systematic Review. JAMA. 2007; 297(22): 2502-14.
7.Abraham WT, Fisher WG, Smith AL, et al. Cardiac Resynchronization in Chronic Heart Failure. N Engl J Med. 2002; 346: 1845-53.
8.Linde C, Abraham WT, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in
Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, 2008.
9.Tang SL, Wells GA, et al. Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure. NEJM 2010;363:2385-95.
10.Brignole M, Auricchio A, et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. European Heart Journal (2013)
34, 2281–2329.
11.Poole JE, Gleva MJ, et al. Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements
and Upgrade Procedures Results From the REPLACE Registry. Circulation. 2010;122:1553-1561.
12.van Deursen C, van Geldorp I, Rademakers L. et al. Left Ventricular Endocardial Pacing Improves Resynchronization Therapy in Canine Left
Bundle-Branch Hearts. Circ Arrhythmia Electrophysiol. 2009; 2: 580-7.
13.Bracke FA, van Gelder BM, Dekker LRC, Woorst JF, Teijink JA. Left Ventricular Endocardial Pacing in Cardiac Resynchronization Therapy: Moving
from Bench to Bedside. Neth Heart J. 2012; 20(3): 118–24.
14.Reddy VY, et al. Abstract LBCT01-05. Wireless LV Endocardial Stimulation for CRT: Primary Results of the Safety and Performance of
Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015;
Boston, Massachusetts.
15.Reddy VY, Neuzil P, et al. Presentation of Wireless LV Endocardial Stimulation for CRT: Primary Results of the Safety and Performance of
Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015;
Boston, Massachusetts.
16.Leon AR, Abraham WT, Curtis AB, et al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart
Failure: Combined Results of Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: 2348–56.
17.Linde C, Abraham WT, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in
Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, 2008.
18.Young JB, Abraham WT, et al. Combined Cardiac Resynchronization and Implantable Cardioversion Defibrillation in Advanced Chronic Heart
Failure, The MIRACLE ICD Trial. JAMA. 2003;289(20):2685-2694.
W I R E L E S S LV
E N D O C A R D I A L PAC I N G
MC-03195 Rev. A
New Hope
for
Heart Failure
CRT Patients
Caution: Not commercially available in the United States
CLINICAL
RESULTS
HOW
IT WORKS
97%
The WiSE CRT System is designed to overcome the limitations of traditional CRT
pacing. It provides wireless, left ventricular (LV), endocardial pacing in patients
with issues related to standard epicardial coronary sinus (CS) pacing leads.
PACES
CO-IMPLANT
DEVICE
97%
of patients achieved
implantation success
(N=35)
of patients who failed
conventional CRT achieved cardiac
resynchronization at 1-month (N=34)
Receiver Electrode
paces by converting the
ultrasound energy
3
WIRELESS
into electrical energy
LV EF%
Baseline and 6m
50
250
2
ENDOCARDIAL
139
171
150
120
2
1.8
131
1
141
Baseline
100
6m
Select-LV: 69.5% pts ≥ 5% increase (N=23)
14, 15
Baseline
80
6m
Baseline
0
6m
SELECT-LV: QRS decrease of 53 ms
(184 to 131 ms or 29% reduction, N=23)14, 15
Select-LV: 64.7% pts ≥
15% improvement in LVESV (N=17)14, 15
Baseline
6m
SELECT-LV: 61.5% pts ≥ 1 class
improvement in functional capability (N=26)14, 15
Transmitter
transmits ultrasound
energy to the
More Physiological Pacing
Receiver Electrode
RECEIVER
ELECTRODE
Stimulates from the inside of the left
ventricle. Endocardial pacing is considered
more physiological – delivering improved
electrical and haemodynamic response.12,13,14
1
LENGTH OF BODY 9.1mm
DETECTS
The SELECT-LV study showed sustained cardiovascular
improvement for complex CRT patients treated with
the WiSE System
Composite Global Score
(Mortality, HF Hosp, NYHA, QOL)
Transmitter
DIAMETER 2.7mm
detects the RV pacing
pulse from
BATTERY
the co-implant
LV site selection of the stimulation
location; designed to enable tailored
therapy to meet individual patient needs.
3
2.6
27.0
10
BiV
168
160
33.7
30
TRANSMITS
Intrinsic
184
20
Freedom in LV Positioning
4
RV only
200
Designed to eliminate lead complications.
NYHA
Baseline and 6m
200
40
Leadless LV Stimulation
CUSTOMIZED
QRS Duration
Baseline to 6m
End Systolic Volume
Baseline and 6m
TRANSMITTER
All in as
little as
2
milliseconds!
81%
of patients experienced
persistent clinical
benefits at 6-months
(N=24)
Select-LV14, 15
Prospect5
Miracle16
Reverse17
Worsened
Unchanged
Improved
Miracle-ICD18
0
10
20
30
40
50
60
70
80
90
CLINICAL
RESULTS
HOW
IT WORKS
97%
The WiSE CRT System is designed to overcome the limitations of traditional CRT
pacing. It provides wireless, left ventricular (LV), endocardial pacing in patients
with issues related to standard epicardial coronary sinus (CS) pacing leads.
PACES
CO-IMPLANT
DEVICE
97%
of patients achieved
implantation success
(N=35)
of patients who failed
conventional CRT achieved cardiac
resynchronization at 1-month (N=34)
Receiver Electrode
paces by converting the
ultrasound energy
3
WIRELESS
into electrical energy
LV EF%
Baseline and 6m
50
250
2
ENDOCARDIAL
139
171
150
120
2
1.8
131
1
141
Baseline
100
6m
Select-LV: 69.5% pts ≥ 5% increase (N=23)
14, 15
Baseline
80
6m
Baseline
0
6m
SELECT-LV: QRS decrease of 53 ms
(184 to 131 ms or 29% reduction, N=23)14, 15
Select-LV: 64.7% pts ≥
15% improvement in LVESV (N=17)14, 15
Baseline
6m
SELECT-LV: 61.5% pts ≥ 1 class
improvement in functional capability (N=26)14, 15
Transmitter
transmits ultrasound
energy to the
More Physiological Pacing
Receiver Electrode
RECEIVER
ELECTRODE
Stimulates from the inside of the left
ventricle. Endocardial pacing is considered
more physiological – delivering improved
electrical and haemodynamic response.12,13,14
1
LENGTH OF BODY 9.1mm
DETECTS
The SELECT-LV study showed sustained cardiovascular
improvement for complex CRT patients treated with
the WiSE System
Composite Global Score
(Mortality, HF Hosp, NYHA, QOL)
Transmitter
DIAMETER 2.7mm
detects the RV pacing
pulse from
BATTERY
the co-implant
LV site selection of the stimulation
location; designed to enable tailored
therapy to meet individual patient needs.
3
2.6
27.0
10
BiV
168
160
33.7
30
TRANSMITS
Intrinsic
184
20
Freedom in LV Positioning
4
RV only
200
Designed to eliminate lead complications.
NYHA
Baseline and 6m
200
40
Leadless LV Stimulation
CUSTOMIZED
QRS Duration
Baseline to 6m
End Systolic Volume
Baseline and 6m
TRANSMITTER
All in as
little as
2
milliseconds!
81%
of patients experienced
persistent clinical
benefits at 6-months
(N=24)
Select-LV14, 15
Prospect5
Miracle16
Reverse17
Worsened
Unchanged
Improved
Miracle-ICD18
0
10
20
30
40
50
60
70
80
90
CLINICAL
RESULTS
HOW
IT WORKS
97%
The WiSE CRT System is designed to overcome the limitations of traditional CRT
pacing. It provides wireless, left ventricular (LV), endocardial pacing in patients
with issues related to standard epicardial coronary sinus (CS) pacing leads.
PACES
CO-IMPLANT
DEVICE
97%
of patients achieved
implantation success
(N=35)
of patients who failed
conventional CRT achieved cardiac
resynchronization at 1-month (N=34)
Receiver Electrode
paces by converting the
ultrasound energy
3
WIRELESS
into electrical energy
LV EF%
Baseline and 6m
50
250
2
ENDOCARDIAL
139
171
150
120
2
1.8
131
1
141
Baseline
100
6m
Select-LV: 69.5% pts ≥ 5% increase (N=23)
14, 15
Baseline
80
6m
Baseline
0
6m
SELECT-LV: QRS decrease of 53 ms
(184 to 131 ms or 29% reduction, N=23)14, 15
Select-LV: 64.7% pts ≥
15% improvement in LVESV (N=17)14, 15
Baseline
6m
SELECT-LV: 61.5% pts ≥ 1 class
improvement in functional capability (N=26)14, 15
Transmitter
transmits ultrasound
energy to the
More Physiological Pacing
Receiver Electrode
RECEIVER
ELECTRODE
Stimulates from the inside of the left
ventricle. Endocardial pacing is considered
more physiological – delivering improved
electrical and haemodynamic response.12,13,14
1
LENGTH OF BODY 9.1mm
DETECTS
The SELECT-LV study showed sustained cardiovascular
improvement for complex CRT patients treated with
the WiSE System
Composite Global Score
(Mortality, HF Hosp, NYHA, QOL)
Transmitter
DIAMETER 2.7mm
detects the RV pacing
pulse from
BATTERY
the co-implant
LV site selection of the stimulation
location; designed to enable tailored
therapy to meet individual patient needs.
3
2.6
27.0
10
BiV
168
160
33.7
30
TRANSMITS
Intrinsic
184
20
Freedom in LV Positioning
4
RV only
200
Designed to eliminate lead complications.
NYHA
Baseline and 6m
200
40
Leadless LV Stimulation
CUSTOMIZED
QRS Duration
Baseline to 6m
End Systolic Volume
Baseline and 6m
TRANSMITTER
All in as
little as
2
milliseconds!
81%
of patients experienced
persistent clinical
benefits at 6-months
(N=24)
Select-LV14, 15
Prospect5
Miracle16
Reverse17
Worsened
Unchanged
Improved
Miracle-ICD18
0
10
20
30
40
50
60
70
80
90
Over 200,000 patients worldwide are estimated to receive
a CRT device each year. However, limitations prevent some
patients from benefiting.
CHALLENGING
PROCEDURE
5%
30%
10%
23%
of patients fail to have coronary sinus (CS) lead
implanted in a single procedure1,2,3
UP TO
EFFICACY RATE
of patients who receive a CRT device don’t benefit
from treatment4,5,6
UP TO
POST IMPLANT
COMPLICATIONS
EBR Systems, Inc.
686 W. Maude Ave., Suite 102
Sunnyvale, CA 94085 USA
of patients experience CS lead complications including
lead dislodgements and phrenic nerve stimulation1,2,7,8,9
www.ebrsystemsinc.com
UP TO
UPGRADES
UP TO
of patients who receive a CRT device already have a
conventional pacemaker or ICD implanted10. Studies
© 2016 EBR Systems, Inc. All Rights Reserved.
WiSE is a trademark of EBR Systems, Inc.
Caution: Not commercially available in the United States
demonstrated a higher risk (18.7%) of developing major
complications during an upgrade to a CRT system11.
PATIENTS THAT MAY BENEFIT
 Patients who have not
responded to CRT
 Patients with an acute or chronic
CS lead issue
 Patients with known risk
associated with a CRT upgrade
1.Leon AR, Abraham WT, Curtis AB, et al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart
Failure: Combined Results of Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: 2348–56.
2.Gras D, Bocker D et al. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety”
Europace (2007) 9, 516–522.
3.Al-Majed NS, McAlister FA, Bakal JA, Ezekowitz JA. Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart
failure. Ann Intern Med 2011;154:401–412
4.Martin DO, Lemke B, et al., Investigation of a novel algorithm for synchronized left ventricular pacing and ambulatory optimization of
cardiac resynchronization therapy: Results of the adaptive CRT trial. HRS 2012 Volume 9, Issue 11, Pages 1807–1814.e1.
5.Chung ES, Leon AR, et al., Results of the Predictors of Response to CRT (PROSPECT) Trial. Circulation. 2008;117: 2608-2616.
6.McAlister FA, Ezekowitz J, Hooton, N, et al. Cardiac Resynchronization Therapy for Patients with Left Ventricular Systolic Dysfunction: A
Systematic Review. JAMA. 2007; 297(22): 2502-14.
7.Abraham WT, Fisher WG, Smith AL, et al. Cardiac Resynchronization in Chronic Heart Failure. N Engl J Med. 2002; 346: 1845-53.
8.Linde C, Abraham WT, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in
Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, 2008.
9.Tang SL, Wells GA, et al. Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure. NEJM 2010;363:2385-95.
10.Brignole M, Auricchio A, et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. European Heart Journal (2013)
34, 2281–2329.
11.Poole JE, Gleva MJ, et al. Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements
and Upgrade Procedures Results From the REPLACE Registry. Circulation. 2010;122:1553-1561.
12.van Deursen C, van Geldorp I, Rademakers L. et al. Left Ventricular Endocardial Pacing Improves Resynchronization Therapy in Canine Left
Bundle-Branch Hearts. Circ Arrhythmia Electrophysiol. 2009; 2: 580-7.
13.Bracke FA, van Gelder BM, Dekker LRC, Woorst JF, Teijink JA. Left Ventricular Endocardial Pacing in Cardiac Resynchronization Therapy: Moving
from Bench to Bedside. Neth Heart J. 2012; 20(3): 118–24.
14.Reddy VY, et al. Abstract LBCT01-05. Wireless LV Endocardial Stimulation for CRT: Primary Results of the Safety and Performance of
Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015;
Boston, Massachusetts.
15.Reddy VY, Neuzil P, et al. Presentation of Wireless LV Endocardial Stimulation for CRT: Primary Results of the Safety and Performance of
Electrodes Implanted in the Left Ventricle (SELECT-LV) Study. Presented at Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015;
Boston, Massachusetts.
16.Leon AR, Abraham WT, Curtis AB, et al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart
Failure: Combined Results of Over 2,000 Patients from a Multicenter Study Program. J Am Coll Cardiol. 2005; 46: 2348–56.
17.Linde C, Abraham WT, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in
Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. JACC Vol. 52, No. 23, 2008.
18.Young JB, Abraham WT, et al. Combined Cardiac Resynchronization and Implantable Cardioversion Defibrillation in Advanced Chronic Heart
Failure, The MIRACLE ICD Trial. JAMA. 2003;289(20):2685-2694.
W I R E L E S S LV
E N D O C A R D I A L PAC I N G
MC-03195 Rev. A
New Hope
for
Heart Failure
CRT Patients
Caution: Not commercially available in the United States