INDICATIONS, SAFETY & WARNINGS
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Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications and Usage: The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.
Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one-month post implant.
Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: infection, arrhythmias, bleeding, hematoma, thrombus, myocardial infarction, transient ischemic attack, stroke, death and device embolization.