With CCM Therapy (EF 45%) is the new milestone to consider life-changing device therapy

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.”

Eligibility For CCM® Therapy

R

Ejection Fraction 25-45%

R

Class III Heart Failure

R

Guideline Directed Medical Therapy

R

Not receiving Cardiac Resynchronization Therapy

Optimizer® Smart with CCM® Therapy: A Revolutionary Approach to Heart Failure

The Optimizer® Smart, a minimally invasive, implantable device, is the first therapy of its kind designed to strengthen the heart so it can contract more forcibly, allowing more oxygen-rich blood to reach the body.

Studies evaluating the FDA-approved therapy have demonstrated the device is safe, and improves overall heart function, and quality of life for patients.3

The Optimizer® Smart improves heart function by delivering Cardiac Contractility Modulation therapy, the company’s proprietary technology, to the heart.3

CCM® therapy sends precisely timed electrical pulses to the heart cells during the absolute refractory period of the beating cycle, just after the heart contracts, to improve systolic contraction of the heart.

The approach was proven to be safe and effective in numerous clinical studies, including several randomized controlled trials, and the results have been published in over 90 articles appearing in leading medical journals.4

The Optimizer® Smart was granted Breakthrough Device designation by the FDA, and it is the first and only FDA-approved (March 2019) device in the United States, or elsewhere in the world, for the delivery of CCM® therapy.

The Optimizer® Smart has been used to treat over 4,000 patients and is currently available in the United States, Europe (obtained CE Mark in October 2016), China, Brazil, India and more than 40 other countries around the world.

HOPE IS HERE

“CCM® therapy has given me my life back. I can’t even call it an impact, it’s literally given me my life back.”

Darlene V

CCM® Therapy Patient

Lois W

CCM® Therapy Patient

“I’m pretty much back to all my normal duties around the barn. I think that the benefit you get from that gives you such a better outlook on life, and just continues to get better all the time.”

“Now, I can go to football games and watch my son coach. My three youngest grandchildren, we’re going to go to Disney World and enjoy our time together – which is all I live for.”

Bob S

CCM® Therapy Patient

Dave H

CCM® Therapy Patient

“I’m pretty surprised by my results. I’ve been able to move boulders in my yard, I’ve pushed a golf cart, I’ve planted trees, I’ve dug up bushes. It’s been a good positive result for me.”

About CCM® Therapy

Impulse Dynamics offers cardiac contractility modulation therapy to treat adults with moderate-to-severe chronic heart failure. CCM® delivers non-excitatory electrical signals to the right side of the intraventricular septum during the absolute refractory period of the ventricular contraction, and does not trigger a new action potential. CCM® signals are delivered by Impulse Dynamics’ Optimizer system (i.e. Optimizer IVs), which is an implantable pulse generator. This device is implanted in a minimally-invasive procedure under local anesthesia, typically in the right pectoral region. CCM® has been evaluated in patients with heart failure with reduced ejection fraction (HFrEF) In contrast to a pacemaker or a defibrillator, the system is designed to modulate the strength of contraction of the heart muscle rather than the rhythm. CCM® therapy is delivered at regular intervals throughout the day.

CCM® Therapy

OUR Journey

2015

FDA Breakthrough Designation

N
March 2019

FDA Approval – Post Market Approval 

May 2019

First commercial implant (Ohio State University)

N
October 2019

FDA Approval of Optimizer® two-lead system

November 2019

Transitional Pass-Through Payment Status for Outpatient Prospective Payment System January 2020

N
December 2020

Applied for NTAP New Technology Add-on Payment for Inpatient Prospective Payment System 2021, to be effective October 1, 2020 if granted

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
View Clinical Trials

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

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.

Impulse Dynamics has committed ourselves to maximizing availability of Cardiac Contractility Modulation to patients who would benefit from it.  To learn more, please contact your local Impulse Dynamics Territory Manager or email reimbursement@impulse-dynamics.com

What Providers are saying about Optimzer® Smart Therapy

Mike Arnold, DNP

Doctor of Nursing Practice

“I see probably in the neighborhood of 20-25 patients a month who would benefit from CCM® Therapy, specifically.”

“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

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.”

“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

Ben D’Souza, M.D.

Electrophysiologist

“I’ve had patients that were wheelchair bound that were able to walk again.”

AAHFN NURSES INTERESTED IN LEARNING ABOUT IMPULSE DYNAMICS

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