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General| Model Number | CM2000 |
|---|---|
| Indication | For patients with New York Heart Association (NYHA) Class III heart failure |
| Implantation Method | Catheter-based implantation into the pulmonary artery |
| Measurement Parameter | Pulmonary artery pressure |
| Power Source | External RF power during measurement |
| Communication Method | Wireless communication to external reader |
| Dimensions | Approximately 15 mm in length and 3 mm in diameter |
| Weight | Less than 1 gram |
| Regulatory Approvals | FDA Approved |
| Device Type | Implantable hemodynamic monitoring system |
| Intended Use | Monitoring pulmonary artery pressure in heart failure patients |
Specifies the patient population and conditions for which the CardioMEMS HF System is intended.
Lists conditions and patient factors that prohibit the use of the CardioMEMS HF System.
Highlights critical safety information and potential risks associated with system use.
Outlines important measures to prevent device malfunction or patient harm during use.
Lists possible complications and negative outcomes associated with the device and procedure.
Defines the required qualifications and training for personnel operating the system.
Step-by-step instructions for configuring the hospital electronics system for device operation.
Detailed steps for performing the catheterization and implanting the sensor.
Presents data on the reduction of heart failure hospitalizations in the treatment group.
Reports significant adverse events determined to be related to the device.
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