Heart failure symptoms can make you feel hopeless, but CCMTM therapy may be a reason to feel hopeful again.
CCM therapy may be an option for people that aren’t adequately responding to heart failure medications.1
The therapy received FDA-approval with a Breakthrough Device designation in 2019 following over 10 years of clinical studies.
Not all cardiologists offer CCMTM therapy yet.
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CCMTM therapy, delivered by the Optimizer® Smart implant, is a new treatment that can help people with heart failure feel better1
- Delivers energy to the heart
- Minimally invasive procedure
The therapy is covered by Medicare and is increasingly covered by commercial insurers. An insurance specialist can help you navigate determining the available coverage from your plan.
The therapy may be an option for people that aren’t adequately responding to heart failure medications.1
SEE IF CCM THERAPY
IS RIGHT FOR YOU
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 is indicated to improve NYHA functional status, 6-minute hall walk distance and quality of life of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for Cardiac Resynchronization Therapy, 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 is not for everyone. CONTRAINDICATIONS AND PRECAUTIONS include:
- Patients with permanent or long-standing persistent atrial fibrillation or flutter
- Patients with a mechanical tricuspid valve
- Patients in whom vascular access for implantation of the leads cannot be obtained