myCardioMEMS for Pc

1. 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.

2. These factors include: patient environment, data services, mobile device operation system and settings, clinic environment, schedule/configuration changes, or data processing.

3. 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.

4. Limitations: Patients must use their own Apple‡ mobile device to receive and transmit information to the my CardioMEMS™ mobile app.

5. myCardioMEMS™ patient application from Abbott is to be used by patients with the CardioMEMS™ HF System.

6. myCardioMEMS patient application lets you receive communications from your clinic about medications and other information.

7. 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.

8. Contraindications: The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

9. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patients information as intended by the clinician.

10. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

11. The myCardioMEMS™ app can provide notification of medication adjustments and reminders, requests for lab work and acknowledgement that the PA pressure readings have been received.

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