Hope is Here for patients with Heart failure
More than 6 million patients have heart failure today, and both the incidence and prevalence are rising rapidly. Until recently, besides optimizing medical therapies, there were few unique alternatives for treating patients with heart failure.
Now breakthrough device therapies have changed everything for a large majority of NYHA Class III patients.
With the advent of cardiac contractility modulation therapy, “Hope is Here” for you and your patients who previously had no option except to medically manage through progressively worsening symptoms to the point of LVAD or transplant.
CCM® can be provided early on – within a wide EF range between 25% and 45% – to enhance quality of life while improving functional status for Class III patients not indicated for CRT.
If your symptomatic NYHA Class III patient is medically optimized, they may qualify for CCM®
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CCM® Therapy Explainer Animation
Who is indicated For?
Patients with the following indications are candidates for CCM® Therapy.
Ejection Fraction 25-45%
Class III Heart Failure
Guideline Directed Medical Therapy
Not receiving Cardiac Resynchronization Therapy
Clinical Evidence
Clinical trials have demonstrated statistically significant and clinically meaningful improvements in the FIX-HF-5C randomized trial.
Improvment in MLWHFQ
CCM® subjects improved 11.7 points in the MLWHFQ score compared to the control group.
MLWHFQ
P-values from the two-sample t-test of the mean differences. Results from the repeated measures mixed model on the change form baseline at 24 weeks including all available data in the model yield a least squares mean difference between treatment and control in the pooled cohort of -10.9 (p<0.0001).
NYHA Class Improvement
CCM® subjects improved their NYHA heart failure status by >1 class 81% of the time compared to 42% in the control group.
NYHA Class Improvement
Numbers and percentages of patients whose NYHA increased by 1 or more class at 24 weeks. Comparison of results from the FIX-HF-5 and FIX-HF-5C studies and in an analysis where data are pooled from both studies
*P-value from Cochran-Mantel-Haenszel test, stratified by baseline etiology
Six Minute Walk Improvement
CCM® subjects walked on average 33.7 meters further than the control group during the 6-minute hall walk test
Six Minute Walk Test
Mechinism of Action
How does CCM®work?
The animation shows how the genes of a patient with heart failulre can become down-regulated, while others become abnormally up-regulated. CCM Therapy has been associated with reversion of these key gene expression back towards normal profiles, which collectively improves myocardial and LV functions.
Refer to Instructions for Use for additional information.
Optimizer® Smart with CCM® Therapy: A Revolutionary Approach to Heart Failure
Dr. Rami Kahwash
Heart Failure Specialist
The Ohio State University Wexner Medical Center
Columbus, OH
“Between 35% and 45% on this Cardi-O-meter, CCM is the only device approved to treat heart failure in both wide and narrow QRS duration. CCM indication still spans 2/3 of patients in the 25% to 35% range who have narrow QRS. CCM effects are more pronounced as the needle moves to the right on the gauge, leaving >45% an appealing target for future research.”
Insurance Coverage
We have pathways to payment with Medicare and commercial payors in multiple care settings – inpatient, outpatient and surgery centers. Additionally, we have a range of resources available for facilities, practitioners and patients related to obtaining access to Optimizer®. Impulse Dynamics has committed ourselves to maximizing availability of Cardiac Contractility Modulation to patients who would benefit from it.
Clinical Trials
FIX-HF-5C Trial
Clinical trials have demonstrated statistically significant and clinically meaningful improvements in the FIX-HF-5C randomized trial:
- CCM® subjects improved 11.7 points in the MLWHFQ score compared to the control group
- CCM® subjects improved their NYHA heart failure status by >1 class 81% of the time compared to 42% in the control group
- CCM® subjects walked on average 33.7 meters further than the control group during the 6-minute hall walk test
Score change in the MLWHFQ
%
Improved NYHA heart failure status by greater than 1 Class
meters further than control group for 6-minute hall walk test
Looking for more educational information on CCM® Therapy, please checkout our VuMedi channel to view our latest webinars or industry theater discussions. Visit our channel
What Providers are saying about Optimzer® Smart Therapy
Andrew J. Kaplan, M.D.
Cardiac Electrophysiologist
“I’ve been amazed at how virtually every single one of my patients has seen a transformation in their life, having received this therapy.”
“The FDA granted breakthrough designation to this device and the reason they did that is because this is the first device-based therapy in this population that can reduce symptoms when medications alone are not enough.”
Matthew A. Goldstein, M.D.
Electrophysiologist
Ben D’Souza, M.D.
Electrophysiologist
“I’ve had patients that were wheelchair bound that were able to walk again.”
“I think if you’re feeling that you have run out of options for the treatment of your heart failure and you haven’t had a conversation with a cardiologist or an electrophysiologist about the role of CCM®, then I think that there are still potential options for you, and you really aren’t at the end of the road.”
Tom Mattioni, M.D.
Electrophysiologist
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