Hope is Here
Are you struggling with heart failure? Hope is here with CCM® Therapy
Start Living For Today
Hope is here. You can start living with CHF better with CCM® Therapy, powered by the Optimizer® Smart Mini system.
Understand Your Heart Failure Treatment Options
CCM® Therapy may be an option for people that aren’t adequately responding to heart failure medications.
Delivered by the Optimizer® Smart Mini Implant, CCM® Therapy can:
Help people with heart failure get back to living
Improves quality of life1
Work more effectively than medications alone
Medications aren’t always
enough to manage symptoms
Strengthen your heart
Designed to improve contraction of the heart
Over 9,000 CCM® Therapy devices have been implanted
As a result, patients receiving CCM® therapy experience a higher quality of life by reducing CHF symptoms such as overwhelming shortness of breath and fatigue.
Life With CCM® Therapy
As with any medical procedure, individual results may vary.
What do cardiologists say?
CCM® Therapy is delivered by the Optimizer® Smart Mini implant, and it is the first and only FDA-approved device in the United States for the delivery of CCM® Therapy.
The therapy has been proven to be safe and effective in numerous clinical studies, including several randomized controlled trials, and the results have been published in over 80 articles appearing in leading medical journals².
Ben D’Souza, M.D.
Electophysiologist
Tom Mattioni, M.D.
Electrophysiologist
Matthew A. Goldstein, M.D.
Electrophysiologist
Find out if CCM® Therapy is right for you or a loved one
The therapy is covered by Medicare and is increasingly covered by commercial insurers. An insurance specialist can help you navigate the available coverage from your plan.
References:
1 Abraham WT, Kuck KH Goldsmith RL, et al. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation. JACC Heart Failure. 6(10), 874-883 (2018).
2 Clinical evidence on file: https://impulse-dynamics.com/providers/clinical-trials/
3 Indication for Use (IFU): https://impulse-dynamics.com/fda-indications-patient-selection/
Indications for Use:
The OPTIMIZER® Smart System, which delivers Cardiac Contractility Modulation (CCM) therapy, is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.
The OPTIMIZER® Smart Mini System, which delivers Cardiac Contractility Modulation (CCM) therapy, is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.
IMPORTANT SAFETY INFORMATION
With all medical procedures there are risks associated with the implant procedure and the use of the device. The risks include but are not limited to arrhythmias including atrial and ventricular bradycardias or tachycardias including fibrillation, stroke, transient ischemic attack, respiratory/ventilatory failure, right atrial or right ventricular perforation, hemorrhage, infection, pericardial effusion, pneumothorax, abnormal cardiac function, worsening heart failure, myocardial tissue damage, and chest pain. In rare cases death can occur.
Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of an OPTIMIZER® Smart Device.
OPTIMIZER® Smart and OPTIMIZER® Smart Mini is not for everyone. CONTRAINDICATIONS AND PRECAUTIONS include:
- Patients with a mechanical tricuspid valve
- Patients in whom vascular access for implantation of the leads cannot be obtained