Indications for Use: The OPTIMIZER®[Smart, Smart Mini, Lite] 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
