DO I QUALIFY?

SEE IF CCM® THERAPY IS RIGHT FOR YOU

QUESTIONS TO HELP DETERMINE IF CCM® THERAPY IS RIGHT FOR YOU OR YOUR LOVED ONE

  1. Has your doctor told you that you have a weakened or failing heart and prescribed you medications for it?

  2. Have you experienced any of the following?
    – Difficulty breathing
    – Trouble climbing a flight of stairs
    – Fatigue or tiredness during the day
    – Swelling in your legs

  3. Do your symptoms make it hard for you to accomplish your normal daily activities?

  4. Do you have an ejection fraction (a measurement of the heart’s pumping efficiency) of 25-45%?

If you answered yes to a majority of these questions, CCM® Therapy may be right for you or your loved one.

Heart failure symptoms can make you feel hopeless, but CCM® therapy may be a reason to feel hopeful again.

The therapy received FDA-approval with a Breakthrough Device designation in 2019 following over 10 years of clinical studies.

Not all cardiologists offer CCM® therapy yet.

Enter your information below to be notified about its availability from cardiologists in your area.

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The questions above are for preliminary screening purposes only and more criteria may apply.

Only a doctor can prescribe the Optimizer® Smart implant. Always discuss your situation and the risks and benefits of a procedure with your doctor.

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 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 indicated for Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.

The OPTIMIZER® Smart Mini System 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 indicated for 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:

  1. Patients with a mechanical tricuspid valve
  2. Patients in whom vascular access for implantation of the leads cannot be obtained