CARDIOVASCULAR
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Remotely monitor your patient's heart failure while improving their quality of life and reducing HF hospitalizations1

The CardioMEMS™ HF System is the first and only wireless heart failure (HF) remote monitor that has been clinically 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 As telemedicine becomes more common, the CardioMEMS HF System is a safe, reliable way to help your patients manage their heart failure.

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CARDIOMEMS HF SYSTEM IS THE ONLY PROVEN, PROACTIVE AND PERSONALIZED PRODUCT FOR BOTH HFREF AND HFPEF PATIENTS

PROVEN: The CardioMEMS HF System is proven through clinical trial data to reduce heart failure hospitalizations2 and mortality3, as well as improve patients’ quality of life1 for HFrEF and HFpEF

PROACTIVE: Actionable measurements of PA pressures allow proactive changes in medical therapy before heart failure symptoms appear4, reducing heart failure hospitalizations

PERSONALIZED: By individually setting patient thresholds, the CardioMEMS HF System allows physicians to personalize and optimize their care and medical management

CardioMEMS 4 Pillars
CLINICAL EVIDENCE AND STUDIES

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

  • 58% reduction in heart failure hospitalizations3
  • 99.7% freedom from device or system related complications3
  • 61% reduction in heart failure hospitalization for HFpEF patients3

For a more comprehensive review of clinical data please visit the evidence tab.

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
  • Reimbursement Information

 

SETTING UP CUSTOMIZED REMOTE MONITORING AND VIRTUAL COMMUNICATION WITH PATIENTS

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) and the myCardioMEMS™ patient app. 

  • By efficiently utilizing the Merlin.net PCN system you can personalize the thresholds for each patient in order to streamline workflow and create notifications only when a patient falls out of range.
  • Remote monitoring keeps patients comfortably at home and minimizes frequency of in person appointments.
  • myCardioMEMS™ app is a mobile app for your patients that lets them receive messages directly from you to their smartphone (or tablet) and set daily medication and reading reminders.

Read through patient information for the CardioMEMS HF System.

 

"To know that someone is watching and helping me by looking at my numbers every day has made the biggest difference in my life."

IRIS W.
Implanted with the CardioMEMS™ HF System in 2015

Iris quote

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)

Reimbursement Information

Complete Follow-up Results from the CHAMPION Trial

CardioMEMS™ HF System Peer to Peer Presentation

CardioMEMS™ HF System On Demand Webinars

MRI Resources and Scan Parameters

CardioMEMS™ HF System Clinical Compendium

MyCardioMEMS™ App Instructional Visual Guide

MyCardioMEMS™ App Flyer

REFERENCES
  1. Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB, for the CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. The Lancet. 2016;387(10017):453-461.
  2. Shavelle DM, Desai AS, Abraham WT, et al. Pulmonary artery pressure-guided therapy for ambulatory heart failure patients in clinical practice: 1-year outcomes from the CardioMEMS post approval study. Presented at: ACC; March 17, 2019.
  3. Abraham J, et al. Association of Ambulatory Hemodynamic Monitoring with Clinical Outcomes in a Concurrent Matched Cohort Analysis. JAMA Cardiology. 2019;4(6):556-563.
  4. Adamson PB. Pathophysiology of the transition from chronic compensated and acute decompensated heart failure: new insights from continuous monitoring devices. Current Heart Failure Reports. 2009;6:287-292.
  5. Jermyn R, Alam A, Kvasic J, Saeed O, Jorde U. Hemodynamic-guided heart-failure management using a wireless implantable sensor: Infrastructure, methods, and results in a community heart failure disease-management program. Clinical Cardiology. 2016. doi: 10.1002/clc.22643.
  6. Desai AS, Bhimaraj A, Bharmi R, et al. Ambulatory hemodynamic monitoring reduces heart failure hospitalizations in “real-world” clinical practice. J Am Coll Cardiol. 2017;69(19):2357-65.
  7. Givertz MM, Stevenson LW, Costanzo MR, et al., on behalf of the CHAMPION Trial Investigators. Pulmonary artery pressure–guided management of patients with heart failure and reduced ejection fraction. J Am Coll Cardiol. 2017;70:1875-86.

Prevent HF hospitalizations by remotely monitoring PA 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 remotely 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 REMOTELY

Changes in PA pressure occur early on in the progression toward cardiac decompensation, and are a direct indicator of worsening heart failure. An increase in PA pressures 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 while reducing the frequency of office visits.

 

REMOTE 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 reduced6
  • Shorter length of patient stay when hospitalized6
  • Better patient quality of life (5 point difference in Minnesota Living with Heart Failure Questionnaire)6
  • Decrease HF hospitalization costs9
  • Lower mortality10,11

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 Your Patient’s Home to You
  • At home, the patient uses the electronics unit 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.
  • Customizable messages about lifestyle or medication changes can be made via the myCardioMEMS™ app.
HF CardioMEMS transmission flow

On-Demand Webinars

We have developed a number of on-demand webinars with industry leaders to further inform you about the CardioMEMS HF System.

To view our webinars, see our professional HF education and training.

 

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.

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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. https://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
  9. Desai AS, Bhimaraj A, Bharmi R, et al. Ambulatory hemodynamic monitoring reduces heart failure hospitalizations in “real-world” clinical practice. J Am Coll Cardiol. 2017;69(19):2357-65
  10. Abraham J, et al. Association of Ambulatory Hemodynamic Monitoring with Clinical Outcomes in a Concurrent Matched Cohort Analysis. JAMA Cardiology. 2019;4(6):556-563.
  11. Givertz MM, Stevenson LW, Costanzo MR, et al., on behalf of the CHAMPION Trial Investigators. Pulmonary artery pressure–guided management of patients with heart failure and reduced ejection fraction. J Am Coll Cardiol. 2017;70:1875-86.

Clinical Evidence

The following trials and studies illustrate the story of clinical evidence for the CardioMEMS™ HF System:

GUIDE-HF Trial

Will be the largest CardioMEMS prospective trial including 3,600 patients (2,600 single arm + 1,000 randomized). Designed to evaluate heart failure hospitalizations, mortality, quality of life, and functional capacity. The goal is to expand device indication to include NYHA Class II-IV and patients with elevated BNP or NT-proBNP levels and no prior heart failure hospitalization. Learn more about this trial at www.guidehf.com.1

2019 MEMS-HF European Study: Safety and Feasibility of Pulmonary Artery Pressure-Guided Heart Failure Therapy: Rationale and Design of the Prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF)

Clinical Research in Cardiology, 107, pages 991–1002.

First prospective multicenter CardioMEMS study from Europe including 234 patients. The first study to show improved quality of life. The study met all safety endpoints and showed a reduction in pulmonary artery pressures with 66% reduction in heart failure hospitalizations (HFH).2

2019 US Post-Approval Study: Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure Patients in Clinical Practice: 1-Year Outcomes from the CardioMEMS Post-Approval Study

As presented at ACC 2019.

Prospective CardioMEMS trial including 1,200 patients. At one year, results showed a reduction in pulmonary artery pressures and a 58% reduction in HFH regardless of ejection fraction. The trial exceeded all safety endpoints and demonstrated excellent patient data transmission.3

2019 Propensity-Matched Cohort Outcomes: Association of Ambulatory Hemodynamic Monitoring of Heart Failure with Clinical Outcomes in a Concurrent Matched Cohort Analysis

JAMA Cardiol. 2019;4(6):556-563

A large retrospective study from a propensity-matched database including 2,174 patients. At one year, there was a 24% reduction in HFH with a 30% reduction in mortality.2

2017 Optimizing Guideline-Directed Medical Therapy: Pulmonary Artery Pressure-Guided Management of Patients with Heart Failure and Reduced Ejection Fraction

JACC, 70(15)

A CHAMPION trial subgroup analysis of patients with reduced ejection fraction on guideline-directed medication therapy (GDMT). Patients able to tolerate an “optimal” therapy tolerating an ACEi/AR and BB had a 43% reduction in HFH with a 57% reduction in mortality per patient-year. Patients on “partial” therapy able to tolerate at least one ACEi/ARB and/or BB had a 33% reduction in HFH with a 37% reduction in mortality per patient-year.4

2017 Real-World Economic Impact: Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in “Real-World” Clinical Practice

JACC, 69(19)

Retrospective real-world study including 1,114 patients. At one year, there was a 34% reduction in HFH and a $13,190 reduction in heart failure hospitalization costs per patient-year.5

2017 First 2000 Commercial Implants: Impact of Practice-Based Management of Pulmonary Artery Pressures in 2000 Patients Implanted with the CardioMEMS Sensor

Circulation, 135(16).

Large retrospective real-world study including 2,000 patients. There was a reduction in pulmonary artery pressures regardless of ejection fraction and consistent patient data transmission compliance.6

2016 CHAMPION Pivotal Trial: Sustained Efficacy of Pulmonary Artery Pressure to Guide Adjustment of Chronic Heart Failure Therapy: Complete Follow-up Results from the CHAMPION Radomised Trial

The Lancet, 387(10017), 453-461.

Pivotal prospective trial including 550 patients. Results showed a 33% annualized reduction in HFH regardless of ejection fraction.2

References
  1. Lindenfeld J, et al. Hemodynamic-GUIDED Management of Heart Failure (GUIDE-HF). Am Heart J. 2019;214:18-27.
  2. Abraham J, et al. Association of Ambulatory Hemodynamic Monitoring with Clinical Outcomes in a Concurrent Matched Cohort Analysis. JAMA Cardiology. 2019;4(6):556-563.
  3. Shavelle, D., et al. Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure Patients in Clinical Practices: Outcomes from the CardioMEMS Post-Approval Study. As presented at ACC 2019.
  4. Givertz MM, Stevenson LW, et al. Pulmonary artery pressure-guided management of patients with heart failure and reduced ejection fraction. JACC. 2017;70:1875-86.
  5. Desai AS, et al. Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in “Real-World” Clinical Practice. JACC. 2017;69(19):2357-2365.
  6. Heywood JT, Jermyn R, Shavelle D, et al. Impact of practice-based management of PA pressures in 2000 patients implanted with the CardioMEMS sensor. Circulation. 2017;135:1509-17.

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, M.D., 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 STEPHANIE PREISTER, CNP

In this video, Stephanie Preister, CNP leads a discussion with patients about the CardioMEMS™ HF System and patient compliance.

Play Video

CARDIOMEMS™ HF SYSTEM: CLINICAL CONSIDERATIONS IN PATIENT SELECTION

In this webinar, Jamie Pelzel, M.D. discusses how understanding disease progression and appropriate advanced therapy referral timing can have a profound impact on patient outcomes.

Video about Clinical Considerations in Patient Selection


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.

Physician Peer-to-Peer Presentation

Patient Candidate Considerations

Patient Quick Education Tool 


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.

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


HOW THE CARDIOMEMS™ HF SYSTEM WORKS

Watch how pulmonary artery pressure monitoring can help your doctor manage your heart failure symptoms.

Play Video

USING YOUR CARDIOMEMS™ HF SYSTEM

See how to set up, operate, clean, repack and troubleshoot your CardioMEMS Patient Electronics System.

Play Video

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

RIGHT-SIDED HEART FAILURE

This type of heart failure affects the right side, or right ventricle, of the heart. It usually results from left-sided heart failure, but it can also be a result of damage to the right ventricle from a heart attack.

Play Video

On our patient page, we also provide testimonial videos where heart failure patients reflect on their experience with the CardioMEMS™ HF System.

For additional patient education resources, please download the patient quick start guide.

 

CARDIOMEMS™ HF SYSTEM: IMPLANT PROCEDURE
Play Video

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

Implant Checklist


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 heart failure.

Patient Management Clinical Quick Guide


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.

Merlin.Net™ PCN Checklist


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 success at home.

Patient Discharge Procedure


TRAVEL LETTER NOTIFICATION

If your patient plans to travel, they can bring this letter with them to help ease the burden of getting through TSA security with their patient electronics system.

Travel Letter Notification


CARDIOMEMS™ HF SYSTEM BILLING AND REIMBURSEMENT

REMOTE MONITORING REIMBURSEMENT GUIDE

This document provides instructions on the CPT codes, supporting sample documentation and Frequently Asked Questions for reporting remote monitoring of the CardioMEMS™ HF System.

Remote Monitoring Reimbursement Guide

On-demand Webinars

Successful Remote Management of Patients with Heart Failure

Phil Adamson, MD hosts an interactive webinar with Eiran Gorodeski, MD, Raymond Benza, MD and J. Thomas Heywood, MD to discuss current challenges and innovative strategies for managing patients remotely. They also address how to best use remotely obtained hemodynamics information from the CardioMEMS™ HF System to empower care in virtual patient visits.

Current Climate of CardioMEMS™ HF System: Remote Monitoring and Telemedicine

In an interactive webinar hosted by Phil Adamson, MD, a discussion is had between Andrew Sauer, MD, Kunjan Bhatt, MD and Arvind Bhimaraj, MD, MPH, FACC, FHFSA. They discuss how remote monitoring of PA pressures using the CardioMEMS™ HF System has helped with management of HF patients during a healthcare crisis. Also addressed is how to prepare for success with telemedicine and how the CardioMEMS™ HF System can fit into these virtual appointments.

COVID-19: Remote Monitoring with the CardioMEMS™ HF System and Virtual Resources to Stay Connected with your Patients

Christina Sauld, APNP hosted an interactive webinar to address how she uses Merlin.net™ PCN to efficiently manage her patients during the COVID-19 pandemic. Presentation also gave webinar participants a platform to discuss concerns related to managing their heart failure patients with remote monitoring.

Merlin.net™ PCN- Making Heart Failure More Than Mangeable

Mike Pudlo, NP presents best practices and tips for utilizing the enhanced Merlin.net™ Patient Care Network (PCN) to improve clinical efficiencies and make heart failure more manageable.

Hemodynamics for Advanced Practitioners

Terrie-Ann Benjamin, MD, MHS explains the use of hemodynamics and evaluation of the right heart catherization as it relates to heart failure patients and managing CardioMEMS™ HF System patients with the Merlin.net™ PCN.

Hemodynamics: A Lost Art

Michelle "Mickie Gilbert, NP, educates on the principles of hemodynamic monitoring in a case study format. She highlights how she utilizes ambulatory pulmonary pressure monitoring through the CardioMEMS™ HF System to improve outcomes for her heart failure patients.

Building a CardioMEMS™ HF System: A Single Site Perspective

In this webinar, Robert Capodilupo, MD showcases his experience in building out his CardioMEMS™ HF System program at the New England Heart Institute.

CardioMEMS™ HF System Workflow Best Practice Strategies

In this webcast, Christina Sauld, APNP presents best practices, identified through workflow research, for incorporating the CardioMEMS™ HF System into clinical practice to improve clinical efficiencies.

CardioMEMS™ PA Sensor Implant Procedure

This is a live CardioMEMS™ PA Sensor implant procedure perfomed by David Shavelle, MD from Keck School of Medicine USC.

TECHNICAL SPECIFICATIONS

CARDIOMEMS™ HF SYSTEM

PA Sensor and Delivery System Contents:

PA Sensor and Delivery System

 

Model Number

Description

CM2000

PA Sensor and Delivery System

 

CARDIOMEMS™ HF SYSTEM

Patient Electronics System

Contents: Patient Electronics System

Model 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

 

INDICATIONS, SAFETY & WARNINGS
INDICATIONS, SAFETY & WARNINGS

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.

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