PROVIDERS

PROVIDING HOPE WHEN HOPE IS LOST

Help Your Patients Find Hope for Living Better with Heart Failure Using Optimizer® Smart

When chronic heart failure (CHF) patients remain symptomatic despite guideline-directed medical therapy and do not qualify for traditional CRT therapy, they’re forced to live with worsening symptoms that diminish their quality of life. It doesn’t have to be this way.

Impulse Dynamics has developed the breakthrough Optimizer® Smart system with Cardiac Contractility Modulation technology to ease the symptoms of CHF for these patients. CCM® therapy delivers precisely timed electrical pulses to the heart cells during the absolute refractory period. It is designed to strengthen and help the heart contract more forcibly, thereby delivering more blood and oxygen to the body.

About the Optimizer® Smart System

The Optimizer® Smart is a minimally invasive, implantable device that delivers a proprietary therapy to patients with heart failure. CCM® therapy is a first-of-a-kind, life-changing treatment alternative for a select population of heart failure patients. The Optimizer® Smart System includes an implantable stimulation device (similar in size to a pacemaker) and an external charging station. The device has a 15-year battery life.

Optimizer is one of the first cardiac devices to be granted Breakthrough Technology designation by the FDA. It went on to an FDA Advisory Panel review where it received a unanimous positive vote on benefit-risk of the device, and ultimately received FDA approval in March of 2019. Optimizer is the first and only FDA-approved device in the United States or elsewhere for the delivery of CCM® therapy.

Clinical Evidence

Evidence from clinical and bench investigations suggest that CCM® therapy improves the heart’s contractility, as it is designed to do, by modifying the function and expression of proteins in the heart muscle.

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

Peer Perspective

Various heart failure providers have shared their real-world experiences with CCM® therapy, and have compared the breakthrough innovation with other device-based treatment options such as BAT or CRT.

 

The Patient and Procedure

Optimizer is indicated to improve 6-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not indicated for CRT and have an LVEF ranging between 25% and 45%.

In eligible patients, the device is implanted in a small pocket under the skin of the upper chest, along with commercially available pacemaker leads that are placed in the heart’s right ventricular septum, while the patient is under light sedation. The device is generally implanted in the right pectoral region into a subcutaneous pocket at a depth of 2.5 centimeters and the pocket is then closed. After implantation, the physician custom-programs and activates the device for the patient. The patient charges the device one hour per week using the external charger. Optimizer® Smart systems are expected to last for at least 15 years before requiring replacement.

Reimbursement

CCM® therapy is covered by Medicare and is increasingly covered by commercial insurers. Impulse Dynamics offers reimbursement support for its trained physicians and their staff, as well as for facilities where Optimizer® Smart procedures are performed. Please utilize the resources provided on our reimbursement page, or contact us for assistance.

Reach Out to an Impulse Dynamics Representative

To learn more about the Optimizer® Smart system or how you can give your patients a renewed sense of hope with the breakthrough treatment approach, reach out to a representative today by calling (856) 642-9933.

 

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