PRODUCT CATALOG

Cardiac Rhythm Management | Heart Failure Monitoring System | PA Pressure Monitoring

CardioMEMS™ HF System

Patient Electronics System

Product Highlights

  • The CardioMEMS™ HF System is the first and only FDA-approved heart failure (HF) monitor proven to significantly reduce HF hospital admissions and improve quality of life in NYHA Class III patients. When used by clinicians to manage HF, the CardioMEMS HF System is:

    -Safe and reliable – demonstrate 98.6% freedom from device or system complications

    -Clinically proven – reduced HF admissions by 33%1

    -Proactive and personalized – patient management through direct monitoring of PA pressure and titration of medications
  • The CardioMEMS HF System provides direct pulmonary artery (PA) pressure monitoring using the sensor, patient electronics system and the Merlin.net™ Patient Care Network (PCN) to manage patient data. Patient-initiated sensor readings are wirelessly transmitted to an electronics unit and stored in a secure website for clinicians to access and review.
  • The patient electronics system is used by the implanting physician to calibrate the sensor, based upon simultaneous readings from the PA catheter.
  • The patient electronic system is designed for patients to use at home.
  • The patient electronics system powers the sensor using RF energy; receives and processes the frequency information from the sensor; and converts the data into pressure waveforms, PA pressure values and heart rate measurements and transmits PA data to the Merlin.net website.


Ordering Information

Contents: Patient Electronics System

Reorder Number Description
CM1100 Patient Electronics System – (Wi-Fi™, Landline, GSM)
CM1130 Handheld Display
CM1140 GSM Modem
CM1170 Fabric Cover
CM1050 Accessory – Positioning Ball
CM3040 WiFi Adaptor
CM1120 Electronics Travel Case
CM3020 US Power Cord - 125V 7A
CM1110 Power Supply
CardioMEMS HF System Patient Electronics System


1. Abraham, W. T., Stevenson, L., Bourge, R. C., Lindenfled, J., Bauman, J., and Adamson, P. B. (2016). Sustained efficacy of pulmonary artery pressure to guide to adjustment of chronic heart failure therapy: Complete follow-up results from the CHAMPION randomized trial.The Lancet, 387(10017), 453-461. http://dx.doi.org/10.1016/S0140-6736(15)007233-0

Rx Only

 

Brief Summary: Prior to using these devices, please review the User’s Manual 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.

 

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

©2018 St. Jude Medical, Inc. All rights reserved.

SJM-MEM-1014-0040(1)a(1)

Customer Support: 855-478-5833

Last Updated: October 18, 2016