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CardioMEMS HF System

Remote Pulmonary Pressure Monitor

CardioMEMS HF System

CardioMEMS Clinical Evidence & Data

The CardioMEMS™ HF System is supported by comprehensive clinical evidence demonstrating significant reductions in HF hospitalizations, pulmonary artery pressures, and improved survival. The evidence base includes randomized controlled trials, real-world registries, and health economic analyses spanning over 8,000 heart failure patients.
 

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Reduction in PA Pressures

44-62% reduction across all ejection fraction categories1-9

Outstanding Safety

Consistent safety profile across 8,000+ patients and all trials1,4-7,10

Excellent Adherence

95%+ data transmission rates with consistent wireless connectivity.3-7

HF Hospitalizations

28-62% reduction across RCTs, with real-world results at 57-62%1-9,11-12

#1 HFpEF & HFrEF Solution

46% HFH reduction—first and only device proven in both populations1-2,4-8,13

Improved Quality of Life

7-point KCCQ improvement with significant functional gains1,4,7

Optimized Medical Management

43% HFH reduction and 57% mortality reduction with optimal therapy.1-2,4-5,10,14

Improved Survival

Significantly improved 24-month survival in HFrEF population1,10,14

Supported by Multiple Study Designs

There are a variety of study designs that each come with inherent strengths and limitations. The CardioMEMS HF System for remote pulmonary pressure monitoring has demonstrated significant clinical benefit regardless of study design.

RANDOMIZED CONTROLLED

The “gold standard” of clinical trials. All patients are implanted and followed prospectively. Patients are blinded to group assignment. Treatment is compared to control.
 

Champion
(N = 550)

Guide-HF
Randomized Arm
(N = 1,000)

Monitor-HF (European)
(N = 348)

SINGLE-ARM

The patient’s pre-implant history serves as the comparator to what the patient experiences prospectively after implant.
 

U.S. Post-Approval
(N = 1,200)

MEMS-HF
(European)
(N = 234)

Coast-HF
(Total Cohort)
(N = 299)

Guide-HF
Single Arm
(N = 1,358)

PROPENSITY MATCHED

Retrospective analysis comparing similar baseline patients over the same time period. Those who were not implanted serve as the “control.”
 

Abraham Medicare
(N = 2,174)

Krim 5-Yr Outcomes
(N = 3,564)

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Randomized Controlled Trials

MONITOR-HF Trial (2023)

MONITOR-HF Trial (2023)

Principal Investigator: Brugts JJ, et al.
Randomized Controlled Trial | N =348

First RCT conducted in usual care setting without increased clinician contact, validating that hemodynamic-guided management benefits translate to real-world clinical practice15

  • 44% reduction in HFH compared to standard care
  • 7-point improvement in patient-reported quality of life
MONITOR-HF Trial

GUIDE-HF Trial (2021)

GUIDE-HF Trial (2021)

Principal Investigator: Lindenfeld J, et al.
Randomized Controlled Trial | N=1,000

Expanded population RCT of 1,000 patients demonstrating 28% HFH reduction and 19% reduction in composite primary endpoint. Results expanded FDA indication to include NYHA Class II patients and elevated BNP-based entry.7

Key Highlights

  • 28% HFH reduction
  • 19% reduction in composite primary endpoint
1,000 Randomized Patients

CHAMPION Pivotal Trial (2011)

CHAMPION Pivotal Trial (2011)

Principal Investigator: Abraham WT
Randomized Controlled Trial | N=550

Pivotal RCT establishing efficacy of wireless PA monitoring in guiding therapeutic decisions to prevent hospitalizations. Foundation for over a decade of confirmatory research.2

  • 33% annualized HFH reduction
33% reduction in HFH


RCT Subgroup Analyses

Synergistic Impact with Guideline-Directed Medical Therapy (2017)

Synergistic Impact with Guideline-Directed Medical Therapy (2017)

Principal Investigator: Givertz MM, et al.
Retrospective Subgroup Analysis | N=456

Establishes that CardioMEMS amplifies the benefit of guideline-directed medical therapy, with cumulative benefit in patients on optimal therapy.14

  • 43% HFH reduction
  • 57% mortality reduction
43% reduction on optimal GDMT

Proven Benefits in HFpEF Patients (2014)

Proven Management in HFpEF Patients (2014)

Principal Investigator: Adamson PB, et al.
RCT Subgroup Analysis | N=119

Landmark subgroup analysis establishing CardioMEMS as the first and only device with randomized evidence of benefit in preserved ejection fraction patients.13

  • 46% lower heart failure hospitalizations at 6 months
46% lower heart failure hospitalizations


Single-Arm Trials

COAST-HF European & Australian Study (2026)

COAST-HF European & Australian Study

Principal Investigator: de Groote P, et al
Prospective Multicenter Single-Arm | N=299

International post-market study evaluating safety and effectiveness of hemodynamic-guided HF management across European and Australian healthcare systems. Real-world evidence demonstrating hospitalization reduction and long-term safety with 98.3% implant success rate.6

  • 69% HFH reduction
  • Improved Quality of Life
69% HFH reduction

GUIDE-HF Single-Arm Analysis (2023)

GUIDE-HF Single-Arm Analysis

Principal Investigator: Mehra M, et al.
Single-Arm cohort | N=1,358
Subgroup analysis presented: Elevated BNP only vs Prior HFH only (n=1,001)

Analysis demonstrating that early intervention with hemodynamic-guided management in NYHA III patients with elevated BNP (no prior hospitalization) may prevent disease progression.16

  • 54% reduction in HFH at 1 year (pre-implant vs post-implant)
  • Significantly lower risk of HF events at 12 months for patients enrolled with elevated BNP, but no prior HFH
Single Arm Trial of Guide-HF Trial

U.S. Post-Approval Study (2020)

US Post-Approval Study

Principal Investigator: Shavelle D, et al.
Prospective Single-Arm | N=1,200

Post-market prospective follow-up confirming sustained safety and efficacy in post-market setting with excellent device reliability and patient data transmission.5

  • 57% HFH reduction regardless of EF reduction
  • Reduction in PA Pressures
57% HFH reduction regardless of HF

MEMS-HF European Study (2020)

MEMS-HF European Study

Principal Investigator: Angermann C, et al.
Prospective Multicenter Single-Arm | N=234

First prospective multicenter CardioMEMS evaluation in European healthcare systems, demonstrating results consistent with U.S. commercial experience.4

  • 62% HFH reduction
  • Improved Quality of Life
62% HFH reduction


Propensity-Matched & Retrospective Analysis

Hemodynamic Monitoring Meta-Analysis (2024)

Hemodynamic Management Meta-Analysis

Principal Investigator: Lindenfeld et al.
Patient-Level Meta-Analysis | Data: CHAMPION, GUIDE-HF, LAPTOP-HF (n=1,350 HFrEF)

First patient-level meta-analysis showing improved survival and fewer HF hospitalizations in patients with HFrEF managed using hemodynamic-guided therapy, based on three randomized controlled trials.10

  • 36% HFH reduction
  • 25% reduction in mortality risk
1,000 Randomized Patients

Propensity-Matched Medicare Analysis (2019)

Propensity-Matched Cohort Outcomes

Principal Investigator: Abraham J, et al.
Propensity-Matched Analysis | N=1,087

Medicare beneficiary claims analysis demonstrating that clinical trial benefits translate into measurable healthcare improvements in real-world Medicare populations.12

  • 24% HFH reduction
  • 30% mortality reduction
24% HFH reduction | 30% Mortality reduction

Real-World Economic Analysis (2017)

Real-World Economic Impact

Principal Investigator: Desai AS, et al.
Healthcare Claims Analysis | N=1,114

Healthcare claims analysis demonstrating cost-effectiveness through hospitalization prevention and quantifying return on investment through HF-related cost reduction.11

  • 34% HFH reduction
  • $13,190 cost reduction per patient-year
$13K reduction in cost

First 2,000 Commercial Implants (2017)

First 2000 Commercial Implants

Principal Investigator: Heywood JT, et al.
Retrospective Real-World | N=2,000

Large retrospective analysis showing transition from clinical trial to commercial use maintained efficacy and safety across a diverse patient population.3

First 2000 commercial implants


CardioMEMS HF System Data at a Glance

StudyDesignNPA PressureHF HospitalizationHFpEFSafetyQoLAdherenceElevated BNP Survival
CHAMPION Pivotal Study2RCT550✓✓ ✓✓   
Proven Benefits in HFpEF Patients13RCT Subgroup119 ✓✓     
Synergistic Impact With GDMT14Retrospective456 ✓     ✓
First 2000 Commercial Implants3Retrospective2,000✓ ✓  ✓  
COAST6Single-Arm299✓✓✓✓ ✓  
Economic Impact11Retrospective Database1,114 ✓      
Propensity-matched Outcomes12Retrospective Database2,174 ✓     ✓
MEMS-HF European Study4Single-arm234✓✓✓✓✓✓  
US Post-approval Study5Single-arm1,200✓✓✓✓ ✓  
GUIDE-HF Study7RCT1,000✓✓✓✓✓✓✓ 
MONITOR-HF Study15RCT348✓✓✓✓✓✓✓ 
Meta-analysis of CHAMPION, GUIDE-HF and LAPTOP10Retrospective1,350 ✓     ✓
GUIDE-HF Single-arm16Single-arm1,358✓✓  ✓ ✓ 

References

  1. Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized controlled trial. The Lancet. 2011;377(9766):658-666.
  2. Abraham WT, Stevenson LW, Bourge RC, et al. 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.
  3. 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.
  4. Angermann C, Assmus B, Anker SD, et al. Pulmonary-artery-pressureguided therapy in ambulatory patients with symptomatic heart failure: the CardioMEMS European monitoring study for heart failure (MEMS-HF). European J of Heart Failure. 2020;22(10):1891-1901.
  5. Shavelle D, Desai A, Abraham W, et al. Lower rates of heart failure and all-cause hospitalizations during pulmonary artery pressure-guided therapy for ambulatory heart failure. Circulation: Heart Failure. 2020;13(8):229-238.
  6. de Groote P, McKenzie S, Flett A, et al. Heart failure hospitalization reduction and long-term safety with remote pulmonary artery pressure monitoring: results of the CardioMEMS heart failure system outside United States (of America) post-market study. Eur Heart J Open. 2026;6(2):oeag021. Published 2026 Apr 1. doi:10.1093/ehjopen/oeag021
  7. Lindenfeld J, Zile MR, Desai AS, et al. Haemodynamicguided management of heart failure (GUIDE-HF): a randomized controlled trial. The Lancet. 2021;398:991-1001.
  8. Zile MR, Mehra MR, Ducharme A, et al. Hemodynamicallyguided management of heart failure across the ejection fraction spectrum: The GUIDE-HF trial. JACC: Heart Failure. 2022;10(12):931-944.
  9. Heywood JT, Zalawadiya S, Bourge RC, et al; CardioMEMS Post-Approval Study Investigators. Sustained reduction in pulmonary artery pressures and hospitalizations during 2 years of ambulatory monitoring. Journal of Cardiac Failure. 2023;29(1):56-66. doi:10.1016/j.cardfail.2022.10.422
  10. Lindenfeld, J, Costanzo, M, Zile, M. et al. Implantable Hemodynamic Monitors Improve Survival in Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2024 Feb, 83 (6) 682–694. https://doi.org/10.1016/j.jacc.2023.11.030
  11. 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.
  12. Abraham J, Bharmi R, Jonsson O, et al. Association of ambulatory hemodynamic monitoring with clinical outcomes in a concurrent matched cohort analysis. JAMA Cardiology. 2019;4(6):556-563.
  13. Adamson PB, Abraham WT, Bourge RC, et al. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circulation: Heart Failure. 2014;7:935-944.
  14. 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.
  15. Brugts, J et al. Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial. The Lancet. May 20, 2023. https://doi.org/10.1016/S0140- 6736(23)00923-6.
  16. Mehra M, Costanzo MR, Zile M, et al; GUIDE-HF Trial Investigators. Primary results of the prospective single arm trial of hemodynamic-guided management of heart failure (GUIDE-HF). Presented at: HFSA Conference; October 2023; Cleveland, OH.
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