CARDIOVASCULAR
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THIS DEVICE IS COMMERCIALLY AVAILABLE FOR USE IN SELECT INTERNATIONAL MARKETS
IMPROVE QUALITY OF LIFE, WITH THE GOAL OF REDUCING HEART FAILURE HOSPITALIZATIONS1

The CardioMEMS™ HF System is the first and only FDA-approved wireless heart failure (HF) monitor that has been proven to significantly reduce heart failure hospitalizations1 and improve quality of life in New York Heart Association (NYHA) Class III patients who have been hospitalized for heart failure in the previous year.1 The CardioMEMS HF System is a safe, reliable way to help your patients manage their heart failure.

CARDIOMEMS™ HF SYSTEM OVERVIEW

The CardioMEMS™ HF System leverages technology to promote ease of use for patients, while providing essential data and insight to clinicians.

The CardioMEMS HF System has shown:

  • 33% overall reduction in heart failure hospitalizations over an average of 18 months2
  • 50% reduction in heart failure hospitalization for HFpEF patients over an average of 18 months3
  • Shorter length or stay when patients are hospitalized1
  • 98.6% freedom from device or system related complications1
  • No pressure sensor failures1
  • Better patient quality of life as shown by significant improvements in Minnesota Living with Heart Failure Questionnaire scores1

Learn more about how the CardioMEMS™ HF System works to monitor pulmonary artery pressure data.

Understand Patient Care And The CardioMems™ HF System

We provide several resources to help clinicians understand and manage patient care related to the CardioMEMS™ HF System. In our workflow resources you will find:

  • CardioMEMS HF System Program Practice Guide
  • CardioMEMS HF System Patient Selection Videos and Guides
  • CardioMEMS HF System Patient Education Videos and Brochures
Set Up Comprehensive Remote Monitoring

After a patient is implanted with the CardioMEMS™ HF System, you can help your patient set up remote monitoring with the Merlin.net™ Patient Care Network (PCN).

  • Merlin.net PCN is a remote follow-up system that imports and manages cardiac information for your patients with Abbott implanted devices. Learn more about Merlin.net PCN.
Building Comprehensive Heart Failure Management

The CardioMEMS™ HF System is an integral part of our heart failure management portfolio. Our vision is to transform the treatment of heart failure by designing best-in-class, integrated technology to extend and improve lives while decreasing the burden of care and reducing costs. Read more about our approach to heart failure management.

Resources And Documentation

Product Manuals (Instructions For Use)

CardioMEMS HF System Peer To Peer Presentation

MRI Resources And Scan Parameters

CardioMEMS HF System Clinical Compendium

References

1. Abraham, W. T., Adamson, P. B., Bourge, R. C., Aaron, M., Costanzo, M. R., Stevenson, L. W., …Yadav, J. S., for the CHAMPION Trial Study Group. (2011). Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomised controlled trial. The Lancet, 377(9766), 658-666. http://dx.doi.org/10.1016/S0140-6736(11)60101-3

2. Abraham, W. T., Stevenson, L., Bourge, R. C., Lindenfled, J., Bauman, J., & 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

3. Adamson, P. B., Abraham, W. T., Bourge, R. C., Costanzo, M. R., Hasan, A. H., Yadav, C., … Stevenson, L. W. (2014). Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction.Circulation: Heart Failure, 7(6), 935-944. http://dx.doi.org/10.1161/circheartfailure.113.001229

MANAGING PULMONARY ARTERY PRESSURE WITH THE CARDIOMEMS™ HF SYSTEM

Traditionally clinicians have focused on physiological markers that appear late in the time course of decompensation. The CardioMEMS™ HF System monitors changes in pulmonary artery (PA) pressure—an early indicator of the onset of worsening heart failure.

The CardioMEMS HF System offers you real-time notification of patient changes, as well as simple, convenient access to secure data for proactive, personalized patient management. It also provides patients with a heightened awareness of the factors affecting their health and a powerful sense of control.

PATHOPHYSIOLOGY OF WORSENING HF1
graph displaying hospitalization times
PROACTIVELY MANAGING PRESSURE

Changes in PA pressure occur early on in the progression toward cardiac decompensation, and are a direct indicator of worsening heart failure. Early changes can often be addressed through titration of medications—reducing the need for hospitalization, and averting serious progression and complication. Small changes early in this process make a big difference, and the CardioMEMS HF System enables a proactive approach to patient care.

TRADITIONAL MARKERS PROVEN TO NOT IMPROVE OUTCOMES

In large randomized controlled studies (TELE-HF, TIM-HF), daily telemonitoring of symptoms, blood pressure and/or weight did not reduce hospitalizations or deaths.2,3

PA PRESSURE MONITORING WITH THE CARDIOMEMS™ HF SYSTEM

Evidence shows CardioMEMS HF System provides:

  • Significant reductions in heart failure hospitalizations in patients with preserved or reduced ejection fraction6,7,8
  • Hospitalization reduced by 1/3 at 18 month6
  • Shorter length of patient stay when hospitalized6
  • Better patient quality of life (5 point difference in Minnesota Living with Heart Failure Questionnaire)6

See more about the effectiveness of monitoring PA pressure in the evidence tab.

HOW THE CARDIOMEMS™ HF SYSTEM WORKS

Monitoring PA Pressure

The CardioMEMS™ HF System provides ambulatory pulmonary artery (PA) pressure monitoring using a small pressure sensor, permanently implanted in the distal pulmonary artery via a safe right heart catheterization procedure.

Patient-initiated sensor readings are wirelessly transmitted to an external electronics unit and stored in a secure website for clinicians to access and review. Directly monitoring PA pressure not only alerts you if a patient’s heart failure is worsening, but allows you to intervene earlier, adjusting medication or making other treatment changes.

graphic explaining how sensing works
CardioMEMS™ HF System Sends PA Pressure Data from Home to You
  • At home, the patient uses the electronics unit and the pillow containing the antenna to take sensor readings daily or upon clinician request. This is a simple process that takes only a few minutes.
  • The patient lies on the pillow and presses a button. The unit captures 18 seconds of pressure readings and wirelessly transmits the data to the secure website.
  • You have access to patients’ data transmissions via a secure website. Pressure readings, trend data and pressure waveforms are displayed in the intuitive patient data management website, providing unique clinical insight for guiding medical management.
graphic showing how transmission works
BUILDING COMPREHENSIVE HEART FAILURE MANAGEMENT

The CardioMEMS™ HF System is an integral part of our heart failure management portfolio. Our vision is to transform the treatment of heart failure by designing best-in-class, integrated technology to extend and improve lives while decreasing the burden of care and reducing costs. Read more about our approach to heart failure management.

REFERENCES

1. Graph adapted from Adamson, P. B. (2009). Pathophysiology of the transition from chronic compensated and acute decompensated heart failure: New insights from continuous monitoring devices. Current Heart Failure Reports, 6(4), 287-92. http://www.ncbi.nlm.nih.gov/pubmed/19948098

2. Chaudhry, S. I., Mattera, J. A., Curtis, J. P., Spertus, J. A., Herrin, J., Lin, Z., … Krumholz, H. M., (2010). Telemonitoring in patients with heart failure. New England Journal of Medicine, 363(24), 2301-2309. http://dx.doi.org/10.1056/NEJMoa1010029

3. Kohler, F., Winker, S., Schieber, M., Sechtem, U., Stangle, K., Bohm, M., … Anker, S. D. (2010, November). Telemedical interventional monitoring in heart failure (TIM-HF), a randomized, controlled, intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with chronic heart failure. Presented at the meeting of the American Heart Association, Chicago, IL. http://dx.doi.org/10.1161/CIR.0b013e318200c0b5

4. van Veldhuisen, D. J., Braunschweig, F., Conraads, V., Ford, I., Cowie, R. M., Jondeau, G., … Borggrefe, M., for the DOT-HF Investigators. (2011). Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with heart failure. Circulation, 124(16), 1719-1726. http://dx.doi.org/10.1161/circulationaha.111.043042

5. Adamson, P. B., Abraham, W. T., Bourge, R. C., Costanzo, M. R., Hasan, A. H., Yadav, C., … Stevenson, L. W. (2014). Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction.Circulation: Heart Failure, 7(6), 935-944. http://dx.doi.org/10.1161/circheartfailure.113.001229

6. Abraham, W. T., Stevenson, L., Bourge, R. C., Lindenfled, J., Bauman, J., & 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

7. Adamson, P. B., Abraham, W. T., Bourge, R. C., Stevenson, L. W., & Yadav, J. (2010). CardioMEMS heart sensor allows monitoring of pressures to improve outcomes in NYHA class III heart failure patients (CHAMPION) Trial: Impact of hemodynamic guided care on patients with preserved ejection fraction. Journal of Cardiac Failure, 16(11), 913. http://dx.doi.org/10.1016/j.cardfail.2010.09.012

8. Weiner, S., Abraham, W. T., Adamson, P. B., Neville, S., & Henderson, J. (2011). Effect of CRT on heart failure related hospitalizations in patients with reduced EF utilizing remote pulmonary artery pressures in the CHAMPION Trial. Heart Rhythm, 8(5S), S437. http://dx.doi.org/10.1016/j.hrthm.2011.03.033

CHAMPION TRIAL DATA

The CHAMPION clinical trial was designed to evaluate the safety and effectiveness of the CardioMEMS™ HF System when used by clinicians to reduce heart failure hospitalizations in NYHA Class III patients.The data prove the efficacy of the CardioMEMS™ HF System.1

Trial Design

graphic showing facts about patients with sensor implants
CLINICAL RESULTS OF THE CHAMPION TRIAL
The CardioMEMS™ HF System Met All Primary Safety Endpoints
  • 98.6% freedom from device or system related complications1 (p < 0.0001 versus pre-specified objective performance criteria (OPC) of 80%*)
  • No pressure sensor failures1 (p < 0.0001 versus pre-specified OPC of 90%*)
Significant Reductions in Heart Failure Hospitalizations in Patients with Preserved or Reduced Ejection Fraction2-4
  • 33% overall reduction in heart failure hospitalizations over an average of 18 months (p < 0.0001)2
  • In patients with preserved ejection fraction, 50% reduction in heart failure hospitalization over an average of 18 months (p < 0.0004)3
  • In patients with reduced ejection fraction, reductions in heart failure hospitalization were achieved in patients with and without a CRT device, demonstrating that the CardioMEMS HF System reduces hospitalizations even in patients receiving CRT therapy4

Learn more about the CHAMPION trial.

ENGAGING AND EMPOWERING PATIENTS

The CardioMEMS HF System is also an effective tool for engaging and involving patients in the process of care. By encouraging patients to participate in the management of their disease, you will increase their awareness of factors that affect their health and well-being, and empower them to make healthy, informed choices.

The CardioMEMS HF System has shown:

  • 33% reduction in HF hospitalization over an average of 18 months2
  • Shorter length of stay when patients are hospitalized1
  • Better patient quality of life as shown by improvement in the Minnesota Living with Heart Failure Questionnaire (MLHFQ)1
  • More days alive outside the hospital1

In recent real-world data, at one year, the CardioMEMS HF System has shown:

  • 58% reduction in heart failure hospitalizations
  • 99.7% freedom from device or system related complications
  • 61% reduction in heart failure hospitalization for HFpEF patients

Other recent data from a retrospective cohort study demonstrates 30% reduction in mortality at 12 months when compared with matched controls from CMS database.

GUIDELINE-DIRECTED MEDICAL THERAPY WITH CRT OR ICD PATIENT DATA

At the 2015 Heart Rhythm Society scientific sessions, Dr. William Abraham presented a retrospective analysis of the CHAMPION Trial. The data showed that PA pressure guided heart failure(HF) management significantly reduced HF hospitalizations and mortality in patients on guideline-directed medical therapy (GDMT) who also had a CRT or ICD device when compared to patients on GDMT with a CRT or ICD device managed with standard of care (SOC).6

Read the presentation abstract.

See additional HRS 2015 data presented by Dr. Lee Goldberg about PA pressure sensor measurements beating clinical signs to guide prevention of HF hospitalizations.

Building Comprehensive Heart Failure Management

The CardioMEMS™ HF System is an integral part of our heart failure management portfolio. Our vision is to transform the treatment of heart failure by designing best-in-class, integrated technology to extend and improve lives while decreasing the burden of care and reducing costs Read more about our approach to heart failure management.

Resources And Documentation
References

*Objective performance criteria based on complications and failure rates for other heart failure monitoring devices and similar OPCs accepted by the FDA.
1. Abraham, W. T., Adamson, P. B., Bourge, R. C., Aaron, M., Costanzo, M. R., Stevenson, L. W., … Yadav, J. S., for the CHAMPION Trial Study Group. (2011). Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomised controlled trial. The Lancet, 377(9766), 658-666. http://dx.doi.org/10.1016/S0140-6736(11)60101-3
2. Abraham, W. T., Stevenson, L., Bourge, R. C., Lindenfled, J., Bauman, J., & 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
3. Adamson, P. B., Abraham, W. T., Bourge, R. C., Stevenson, L. W., & Yadav, J. (2010). CardioMEMS heart sensor allows monitoring of pressures to improve outcomes in NYHA class III heart failure patients (CHAMPION) Trial: Impact of hemodynamic guided care on patients with preserved ejection fraction. Journal of Cardiac Failure, 16(11), 913. http://dx.doi.org/10.1016/j.cardfail.2010.09.012
4. Weiner, S., Abraham, W. T., Adamson, P. B., Neville, S., & Henderson, J. (2011). Effect of CRT on heart failure related hospitalizations in patients with reduced EF utilizing remote pulmonary artery pressures in the CHAMPION Trial. Heart Rhythm, 8(5S), S437. http://dx.doi.org/10.1016/j.hrthm.2011.03.033
5. Abraham, W. T., Adamson, P., Stevenson, L., & Yadav, J. (2015). Pulmonary artery pressure management in heart failure patients with reduced ejection fraction significantly reduces heart failure hospitalizations and mortality above and beyond background guideline-directed medical therapy. Journal of the American College of Cardiology, 61(10), A790. http://dx.doi.org/10.1016/S0735-1097(15)60790-2
6. Abraham, W. T., Adamson, P., Stevenson, L., Costanzo, M., Bourge, R., Bauman, J., & Yadav, J. (2015, May). Pulmonary artery pressure management in heart failure patients with cardiac resynchronization therapy or implantable cardioverter devices significantly reduces heart failure hospitalizations and mortality above and beyond background guideline-directed medical therapy. Presented at the meeting of the Heart Rhythm Society, Boston, MA.

CardioMems™ HF System

PA Sensor and Delivery System Contents:

PA Sensor and Delivery System

SPECIFICATIONS

 

Reorder Number

Description

CM2000

PA Sensor and Delivery System

CardioMems™ HF System

Patient Electronics System

Contents: Patient Electronics System

SPECIFICATIONS

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

CM1110

Power Supply

 

 

CARDIOMEMS™ HF SYSTEM WORKFLOW RESOURCEs

We provide the following resources to help clinicians understand and manage patient care related to the CardioMEMS™ HF System.

CardioMEMS™ HF System Program Practice Guide

Download the CardioMEMS™ HF System Program Practice Guide.This interactive guide is a comprehensive resource to help clinicians manage clinical programs more efficiently for heart failure patients who have received a CardioMEMS™ HF System.

CardioMEMS™ HF System Patient Selection Resources

CardioMEMS™ HF System Patient Approach With Philip B. Adamson, MD, MSC, FACC

In this video, Philip B. Adamson, M.D., MSc, FACC, reviews essential tips to approaching patients about their symptoms and engaging in conversation about the CardioMEMS™ HF System.

Play Video
CARDIOMEMS™ HF SYSTEM PATIENT APPROACH WITH JAMIE PELZEL, MD

In this video, Jamie Pelzel, MD, reviews essential tips to approaching patients about their symptoms and engaging in conversation about the CardioMEMS™ HF System.

Play Video

For information on patient selection, please download the physician peer-to-peer presentation guide for the CardioMEMS™ HF System and the patient candidate considerations. Use the Patient Quick Education Tool with your patients to visually explain the benefits and components of the CardioMEMS HF System.

CardioMEMS™ HF System Patient Education

How to Stay Above Heart Failure: Talking to Your Patient About the Cardiomems™ HF System

Once you’ve identified the heart failure patients you think could benefit from the CardioMEMS™ HF System, this resource can help you educate and prepare your heart failure patients to receive the CardioMEMS™ HF System.

UNDERSTANDING HEART FAILURE

See how heart failure affects your heart’s ability to pump blood to the body.

Play Video
LEFT-SIDED HEART FAILURE

Learn about this type of heart failure, which affects the left ventricle (lower, left side) of the heart.

Play Video
CardioMEMS™ HF System: Implant Procedure
Play Video

Get an overview of the implant procedure of the CardioMEMS™ PA sensor in the pulmonary artery.

CARDIOMEMS™ HF SYSTEM PATIENT MANAGEMENT

PATIENT MANAGEMENT CLINICAL QUICK GUIDE

Heart failure is a difficult condition to manage. This resource provides you an overview of best practice methods to effectively use the CardioMEMS™ HF System to track your patient’s pulmonary artery pressure over time to help better manage their HF.

MERLIN.NET™ PATIENT CARE NETWORK (PCN) CHECKLIST

After a patient is implanted with the CardioMEMS™ HF System, this resource can aid in appropriately setting up the patient for successful remote monitoring in the Merlin.Net™ PCN.

PATIENT DISCHARGE PROCEDURE

When the patient is ready to be discharged from the hospital, the care team can use the patient discharge procedure checklist to ensure all important steps are followed to set the patient up for succes at home.

References

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Android is a trademark of Google LLC.

Indications, Safety & Warnings

Rx Only

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.

Limitations: Patients must use their own Apple or Android mobile device to receive and transmit information to the myCardioMEMS™ mobile app. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi) available. 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. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.

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