22-09-29 Why CCM Level 1 - Worldwide.pptx

Why CCM®
Therapy?
Worldwide (ex. US)

Disclaimer
Important
You can only share publications evaluating off-label use(s) of CCM® therapy under the
following conditions:
1. The information you share is in response to an unsolicited request for the
information contained or referenced in this document
2. you have documented the time and place of the unsolicited request that
preceded your distribution of this document
If you have questions, please consult with your manager at Impulse Dynamics

Glen Clardy –
• May 2002 - 42 Years Old
• Diagnosis - Idiopathic Cardiomyopathy
• 2 Daughters 14 & 18 Years Old
• Spring 2004
• Laid off from work
• Needed to rest several times climbing stairs
• Frequent VT - ICD Implanted
• Doctor's Advice "Get your affairs in order . . ."
"I asked my friend to walk my daughters down the
aisle, and I reviewed my will."
IN HIS WORDS

Glen Clardy
• Fall 2004
• Optimizer CCM therapy delivery system implanted
• Felt better in 4 months - EF ▲ to 50%
• Today (≈18 Years later)
• Celebrated 41st anniversary -
• Gave both daughters away in marriage - 2 Grandchildren
• Celebrated 60th birthday hiking in Yosemite National Forest

Heart Failure
A Worldwide Pandemic - With Significant Consequences
• Heart Failure accounts for:
• 33% of the total costs of Medicare ($124B of $373B) 4
• over half of these costs are spent on hospitalizations 5
1 2020 Groenewegen, et al, EJHF - Epidemiology of Heart Failure - doi:10.1002/ejhf.1858
2 2002 Lloyd-Jones, et al, Circulation - Lifetime Risk for Developing Congestive Heart Failure – The Framingham Heart Study - https://doi.org/10.1161/01.CIR.0000039105.49749.6F
3 2017 Taylor, et al, Survival following a diagnosis of heart failure in primary care - doi:10.1093/fampra/cmw145
4 The Cost Burden of Worsening Heart Failure in the Medicare Fee For Service Population: An Actuarial Analysis - Milliman 2017
5 2013 Yancy et al, 2013 ACC-AHA Guidelines for the Treatment f Heart Failure DOI 10.1161-CIR.0b013e31829e8776
5

Heart Failure
Common Signs & Symptoms6
6
6
6 Calvert MJ, et al. European Journal of Heart Failure. 2005. 7:243-251.

Gap in care
7 2017 - Greenhalgh, et al. BMC Cardiovascular Disorders - DOI 10.1186/s12872-017-0594-2
Initiation of neurohormonal therapy
Heart Failure
Typical Patient Journey7
7
Bblockers
ARNI (e.g.,Entresto)
MRA (e.g., Spironolactone)
SGLT2
CRT
6%
0.05%
LVAD
TRANSPLANT
0.05%
Risk of sudden death from arrhythmia
Onset
of CHF
Relatively
stable phase
Episodic (sub-acute)
decompensation
Pump
failure
Time
QoL

All Heart Failure
(Worldwide)
56.70M8
HFpEF HFrEF
5,539,590
NYHA Class IV 9
19,765,620
NYHA Class III 9
24,488,730
NYHA Class II 9
6,906,060
NYHA Class I 9
Heart Failure
Worldwide Prevalence & Therapy Options - Before CCM ®
1 2020 Viarani, et al, AHA Heart Disease and Stroke Statistics - 2020 Update httpsdoi.org10.1161CIR.000000
8 2017, Braunschweig - doi:10.1002/ejhf.563, 2017 Stork - doi: 10.1007/s00392-017-1137-7. 2018 Zhang - https://doi.org/10.1186/s12911-018-0625-7
No Option,
20,747,475
CRT,
4,149,495
NYHA II & III
HFrEF = 24.90M
8

Heart Failure
Worldwide Prevalence & Therapy Options - Before and Now With CCM ®
9
CCM,
20,747,475
CRT,
4,149,495
NYHA II & III
HFrEF = 2.85M
Simple - Safe - Effective
All Heart Failure (US)
56.70M8
HFpEF HFrEF
5,539,590
NYHA Class IV 9
19,765,620
NYHA Class III 9
24,488,370
NYHA Class II 9
6,906,060
NYHA Class I 9

CRT Landmark Trials
Now a Class 1 Indication
10
10 For CRT: Higgins JACC 2003, Abraham NEJM 2002, Abraham Circulation 2004, Young JAMA 2003, Cazeau NEJM 2001, Leclercq EHJ 2002
11 For CCM 25-45% - 2020 - Wiegn, et al, Circulation Heart Failure - doi.org/10.1161/CIRCHEARTFAILURE.119.006512
12 For CCM 35-45% - 2018 - Abraham, et al, JACC Heart Failure - doi.org/10.1016/j.jchf.2018.04.010
Note - data weighted by patient numbers and provided only as a comparison
0.91
9.5
20 67%
Peak Vo2 (ml/kg/min) MLWHFQ (points)
Clinically Meaningful @ 5 Points
6MHW (meters)
Clinically Meaningful @ 25M
NYHA (% Improving ≥ 1 Class)
CRT

0.91
9.5
20 67%
1.7
11.4 34
81%
6MHW (meters)
CRT
CCM
11
CRT and CCM® Landmark Trials
Outcomes Comparison
11
50% of this
group improved
by 2 NYHA
classes!
A 6% Increase in
PVO2
An 8%
Decrease in CV Death &
Heart Failure
Hospitalization
-9%
-7%
-5%
-3%
-1%
1%
3%
5%
7%
=
13 2012 Swank, et al, Circ Heart Fail. 2012;5:579-585
DOI: 10.1161/CIRCHEARTFAILURE.111.965186

12
12
CCM® Real-World Registry (n=503)13
Effect on Cardiovascular and HF-Related Hospitalizations
14 2021 Kuschyk et al, European Journal of Heart Failure doi:10.1002/ ejhf.2202
0.74
0.25
0.30
0.15
0.00
0.20
0.40
0.60
0.80
1.00
1.20
12 Months Pre-Implant 24 Months Post-Implant
Comparison of Event Rates Pre- and Post-CCM Implantation
(n=503)
HF Hospitalizations CV Hospitalizations
▼63%

13
16 2016 - Liu, et al, International Journal of Cardiology - http://dx.doi.org/10.1016/j.ijcard.2016.01.071
13
100-month Kaplan–Meier analysis for the composite endpoint
of all-cause mortality or HF hospitalization in the subgroup
with EF 25 - 40%
CCM® Clinical Outcomes
Sustained and Durable Treatment Effects Over 8+ Years1
b: EF 25-40%
CCM patients 4X
less likely to
experience these
events

14
Optimizer approved
CCM® Worldwide Utilization
≥ 7,000 Patients Implanted In 44 Countries Worldwide
Optimizer® Smart was the first
breakthrough device to go before the
Circulatory System Devices Panel of the
FDA’s Medical Devices Advisory
Committee on December 4, 2018,
receiving a unanimous 12-0
recommendation for approval based on
the benefit-to-risk ratio of the device.

CCM® Therapy Delivery
Simple - Safe - Effective
Simple
• Procedure is like a dual-chamber pacemaker
implant
Safe
• Low complication rates - like pacemaker implants
Effective
• 81% improved by ≥ 1 NYHA Class
• ½ of those improved by 2 classes
15
20 Year Longevity
Rechargeable

Improves contractility
Minutes to Hours(1-3)
Rapid
Optimizer®
Smart Mini
Therapy Effects
16
Reverse remodeling
Weeks to Months(~4)
Long-Term
Normalizes gene profile
Hours to Weeks(1-3)
Intermediate
i

The Science Behind CCM®
More Than 100 Publications in Peer-Reviewed Journals
Select Publications
• Kuschyk, et al: “Long Term Clinical experience with cardiac
contractility modulation delivered by the Optimizer Smart system”
European Journal of Heart Failure, May 2021
• Tschöpe, et al: - Clinical effects of cardiac contractility modulation in
heart failure with mildly reduced systolic function
ESC Heart Failure, December 2020
• Abraham, et al: “A Randomized Control Trial to evaluate the safety
and efficacy of Cardiac Contractility Modulation”
JACC HF, May 2018
• Tschope, et al: “Cardiac contractility modulation: mechanisms of
action in heart failure with reduced ejection fraction and beyond”
European Journal of Heart Failure, August 2018
• Borggrefe and Mann: “Cardiac Contractility Modulation in 2018”
Circulation, December 2018
• Butter, et al: “Cardiac Contractility Modulation Electrical Signals
Improve Myocardial Gene Expression in Patients with heart failure”
Journal of the American College of Cardiology, May 2008
• Borggrefe, et al: “Randomized, double blind study of non-excitatory,
cardiac contractility modulation electrical impulses for symptomatic
heart failure”
European Heart Journal, January 2008 17
i

0.91
9.5
20 67%
1.7
11.4 34
81%
2.32
14.9
57
82%
6MHW (meters)
CRT
CCM
CCM (EF 35-45%)
18
CRT and CCM® Landmark Trials
Outcomes Comparison
18
50% of both
these groups
improved by 2
NYHA classes!

Heart Failure
AIM HIGHer Seeks Safety & Efficacy for a Population >6X Larger than HFrEF
19
No Option,
20,747,475
CRT,
4,149,495
NYHA II & III
HFrEF = 24.90M
CCM
24,896,970
Symptomatic HF
HFpEF= 24.90M
All Heart Failure
(Worldwide)
56.70M8
HFpEF HFrEF
5,539,590
NYHA Class IV 9
19.765,620
NYHA Class III 9
24,488,730
NYHA Class II 9
6,609,060
NYHA Class I 9

> 35%
to
≤ 45%
• Fewer heart failure meds
• Not indicated for ICD
• Indicated for CCM® therapy
• General cardiologist
• +/- Heart failure cardiologist
≥ 25%
to
≤ 35%
• Multiple heart failure
medications
• Meets ICD indications
• Indicated for CCM® therapy
• General cardiologist
• Heart failure cardiologist
• Electrophysiologist
CCM® Therapy Worldwide (ex. the US)
Who and where are the right patients?
They're among your HFrEF patients that
remain symptomatic despite GDMT
What is their
EF?
What does the
patient look like?
Who does the
patient see?
20
CCM
(EF >35 - ≤45%),
427,324
CCM
(EF ≥25 - ≤35%)
427,324
CRT (EF < 35%),
200,000
NYHA II & III
HFrEF = 24.90M

• Heart failure is a massive challenge
• Accounts for 1/3 of all hospital costs
• For many patients, there is a gap in care from medications to
LVAD / heart transplant
• CRT can help some of these patients
• CCM can now help even more patients
• Study results similar to CRT
• Over 7,000 patients treated
• >100 publications
• CCM is simple, safe, effective, and well-reimbursed
CCM® Therapy
In Summary
21

CCM® Therapy Delivery
Patient Testimonial - George Marra
• 2003 – Developed HF
• Continued to get worse despite GDMT - described himself as "a vegetable"
• 2006 - Enrolled in CCM clinical trial; assigned to non-treatment group
• Kept getting worse and was hearing how well Optimizer patients were doing
• Did his own research and found he could get CCM in Germany
• 2007 Paid out of pocket for the trip and the procedure
• 2021 Submitted his story (voluntarily) to Impulse Dynamics website
• 2022 (19 years later) feeling great and enjoying retirement in Belize
22
George & Lynn Marra in Lamani, Belize (2014)
“and it's not just George, it's me and our whole
community who have, and continue, to benefit."
Lynn Marra 2022

22-09-29 Why CCM Level 1 - Worldwide.pptx

Recommended

Recommended

More Related Content

Similar to 22-09-29 Why CCM Level 1 - Worldwide.pptx

Similar to 22-09-29 Why CCM Level 1 - Worldwide.pptx (20)

Recently uploaded

Recently uploaded (20)

22-09-29 Why CCM Level 1 - Worldwide.pptx