Patient Safety information for CCMTM cardiac contractility modulation therapy, delivered by the Optimizer® Smart implant.
What is CCMTM therapy, delivered by the Optimizer® Smart implant, used for? (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%.
Are there any reasons why I should not be treated with by the Optimizer® Smart implant?
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
What are possible side effects and risks?
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.