# CardioMEMS HF System

Product · id `cardio:cardiomems-hf-system` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Also called: CardioMEMS HF Pressure Measurement System

Browse, organ or system: Heart  
Browse, condition area: Heart failure  

## In plain language

A small sensor that is placed in an artery of the lung to measure the pressure there and send the readings wirelessly. The US FDA approved it on 28 May 2014 for people with NYHA class III heart failure who have been in hospital for heart failure in the previous year. In the CHAMPION trial, people whose care was adjusted using these readings had fewer hospital admissions for heart failure over 6 months than people given standard care alone. Only patients were masked in that trial.

## Technical summary

Premarket approval P100045, product code MOM, device class 3. The approval order statement in the openFDA record lists the CM2000 implantable sensor and monitor with its delivery system, the patient electronics and the hospital electronics. The record lists ABBOTT MEDICAL as the applicant today and 90 later supplements; their content was not read. The registry names the CHAMPION device HF Pressure Measurement System, and the openFDA trade name is CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM; this page does not state that the trial device and the approved device are the same product version. The current openFDA registration listing names Abbott Medical as a manufacturing establishment for the P100045 devices; that listing is current and does not show who made the sensor in 2014.

## Claims, with the population each applies to

## Context: Adults with NYHA class III heart failure and a past heart-failure hospital admission, at 64 US centres (CHAMPION)

Recipient: Adult; Population: Patients with New York Heart Association class III heart failure, irrespective of ejection fraction, and a previous hospital admission for heart failure. The registry gives a minimum age of 18 years.; Care setting: Enrolled at 64 centres in the USA (abstract). The abstract does not say whether they were hospitals or outpatient clinics.; Geography: United States (abstract and registry).; Life stage: Adults, 18 years and over (registry minimum age). The abstract gives no mean age.; Follow-up: At least 6 months of randomized follow-up for the main comparison; mean 15 months in the whole follow-up (abstract).

### In CHAMPION, people with New York Heart Association class III heart failure, irrespective of ejection fraction, and a previous hospital admission for heart failure were randomly assigned to management with a wireless implantable haemodynamic monitoring system (treatment group) or to a control group, for at least 6 months. In the treatment group, clinicians used daily pulmonary artery pressure readings in addition to standard care; the control group had standard care alone. Only patients were masked to their group. At 6 months there were 83 heart-failure-related hospitalisations in the treatment group (270 people) and 120 in the control group (280 people), a rate of 0.31 against 0.44 (hazard ratio 0.70, 95% CI 0.60 to 0.84). Over the whole follow-up, with a mean of 15 months, there were 153 such hospitalisations in the treatment group against 253 in the control group (hazard ratio 0.64, 95% CI 0.55 to 0.75). Eight patients had a device-related or system-related complication; freedom from these was 98.6% (95% CI 97.3 to 99.4) against a prespecified criterion of 80%, and freedom from pressure-sensor failure was 100% (99.3 to 100.0).

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Adult; Population: Patients with New York Heart Association class III heart failure, irrespective of ejection fraction, and a previous hospital admission for heart failure. The registry gives a minimum age of 18 years.; Care setting: Enrolled at 64 centres in the USA (abstract). The abstract does not say whether they were hospitals or outpatient clinics.; Geography: United States (abstract and registry).; Life stage: Adults, 18 years and over (registry minimum age). The abstract gives no mean age.; Follow-up: At least 6 months of randomized follow-up for the main comparison; mean 15 months in the whole follow-up (abstract).
- Limitations: One single-blind trial: only patients were masked, so clinicians were not. The comparison counts hospitalisations as events, not people. The abstract names CardioMEMS as the funder, and the device studied is the CardioMEMS system. PubMed links an erratum to the paper (Lancet 2012;379:412), and Crossref lists an erratum with DOI 10.1016/s0140-6736(12)60193-7 dated 2012-02-04. The erratum text could not be read, so it is unknown whether it changes any figure here. The numbers come from the PubMed abstract; the full text and registry results were not read. The abstract gives no result on deaths. No certainty rating was assessed.
- Last checked: 2026-10-14
- Source problem: a cited source is corrected. Check the sources before relying on this claim.
- Sources:
  1. Supports: Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read.) <https://doi.org/10.1016/S0140-6736(11)60101-3>
     Locator: Abstract, FINDINGS, sentence 1. Retrieved 2026-10-14T18:18:46Z. Source state: Corrected. Snapshot hash: d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1.
     How it applies: Six-month hospitalisation counts, group sizes and hazard ratio. Abstract of the paper from PubMed; the full text was not read.
  2. Supports: Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read.) <https://doi.org/10.1016/S0140-6736(11)60101-3>
     Locator: Abstract, FINDINGS, sentence 2. Retrieved 2026-10-14T18:18:46Z. Source state: Corrected. Snapshot hash: d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1.
     How it applies: Whole follow-up hospitalisation counts and hazard ratio. Abstract of the paper from PubMed; the full text was not read.
  3. Supports: Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read.) <https://doi.org/10.1016/S0140-6736(11)60101-3>
     Locator: Abstract, FINDINGS, sentence 3. Retrieved 2026-10-14T18:18:46Z. Source state: Corrected. Snapshot hash: d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1.
     How it applies: Device-related complications and sensor failures. Abstract of the paper from PubMed; the full text was not read.
  4. Background: Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read.) <https://doi.org/10.1016/S0140-6736(11)60101-3>
     Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-14T18:18:46Z. Source state: Corrected. Snapshot hash: d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1.
     How it applies: Population and sites. Abstract of the paper from PubMed; the full text was not read.
  5. Background: Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read.) <https://doi.org/10.1016/S0140-6736(11)60101-3>
     Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:46Z. Source state: Corrected. Snapshot hash: d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1.
     How it applies: Randomization and the length of the comparison. Abstract of the paper from PubMed; the full text was not read.
  6. Background: Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read.) <https://doi.org/10.1016/S0140-6736(11)60101-3>
     Locator: Abstract, METHODS, sentence 3. Retrieved 2026-10-14T18:18:46Z. Source state: Corrected. Snapshot hash: d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1.
     How it applies: Only patients were masked. Abstract of the paper from PubMed; the full text was not read.
  7. Background: Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read.) <https://doi.org/10.1016/S0140-6736(11)60101-3>
     Locator: Abstract, METHODS, sentence 4. Retrieved 2026-10-14T18:18:46Z. Source state: Corrected. Snapshot hash: d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1.
     How it applies: What the treatment group did differently. Abstract of the paper from PubMed; the full text was not read.
  8. Background: Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists an erratum for this paper (Lancet 2012 Feb 4;379(9814):412) without a PMID or text. The erratum was not read.) <https://doi.org/10.1016/S0140-6736(11)60101-3>
     Locator: Abstract, FUNDING, sentence 1. Retrieved 2026-10-14T18:18:46Z. Source state: Corrected. Snapshot hash: d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1.
     How it applies: Funder named in the abstract. Abstract of the paper from PubMed; the full text was not read.
  9. Background: Crossref record for the CHAMPION paper (10.1016/S0140-6736(11)60101-3) (Dataset, edition Crossref REST API record fetched 2026-10-14. It lists one update to the paper, an erratum.) <https://api.crossref.org/works/10.1016/S0140-6736(11)60101-3>
     Locator: message.updated-by\[0\].DOI. Retrieved 2026-10-14T19:17:15Z. Source state: Current. Snapshot hash: b76a0476b5ad9cf55365b1463d2ff356f63acaba583a8777e58afd3913eb899b.
     How it applies: Crossref lists an erratum for this paper, by DOI.

## Context: United States premarket approval P100045 for the CardioMEMS HF System

Recipient: Recipient not specified; Population: People with New York Heart Association class III heart failure who have been hospitalized for heart failure in the previous year, as the FDA approval order statement words the indication.; Care setting: Not stated in the FDA record beyond the indication wording.; Geography: United States (decision by the US Food and Drug Administration); Life stage: Not stated in the openFDA record. The indication wording gives no age limits.; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)

### The US Food and Drug Administration approved premarket approval application P100045 for the CardioMEMS HF Pressure Measurement System on 28 May 2014. The approval order statement in the openFDA record says the device is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in New York Heart Association class III heart failure patients who have been hospitalized for heart failure in the previous year, and that physicians use the hemodynamic data for heart failure management with the goal of reducing heart failure hospitalizations. The record lists FDA product code MOM and device class 3.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: Recipient: Recipient not specified; Population: People with New York Heart Association class III heart failure who have been hospitalized for heart failure in the previous year, as the FDA approval order statement words the indication.; Care setting: Not stated in the FDA record beyond the indication wording.; Geography: United States (decision by the US Food and Drug Administration); Life stage: Not stated in the openFDA record. The indication wording gives no age limits.; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- Limitations: The openFDA record is the original approval; the same response lists many later supplements, whose content was not read, so the indication may have changed. The record lists ABBOTT MEDICAL as the applicant today and does not say who held the application in 2014. The approval order statement is FDA's wording of the indication and is not a finding about how well the device works. openFDA's own disclaimer says not to rely on it for decisions about medical care.
- Last checked: 2026-10-14
- Sources:
  1. Supports: openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System (Regulator, edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement\_number (results\[53\]).) <https://api.fda.gov/device/pma.json?search=pma_number:%22P100045%22&limit=100>
     Locator: results\[53\].pma\_number. Retrieved 2026-10-14T18:20:06Z. Source state: Current. Snapshot hash: 85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998.
     How it applies: The PMA number. The record with an empty supplement\_number is the original approval.
  2. Supports: openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System (Regulator, edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement\_number (results\[53\]).) <https://api.fda.gov/device/pma.json?search=pma_number:%22P100045%22&limit=100>
     Locator: results\[53\].decision\_date. Retrieved 2026-10-14T18:20:06Z. Source state: Current. Snapshot hash: 85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998.
     How it applies: ISO decision date of the original approval.
  3. Supports: openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System (Regulator, edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement\_number (results\[53\]).) <https://api.fda.gov/device/pma.json?search=pma_number:%22P100045%22&limit=100>
     Locator: results\[53\].decision\_code. Retrieved 2026-10-14T18:20:06Z. Source state: Current. Snapshot hash: 85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998.
     How it applies: APPR is FDA's decision code for an approval.
  4. Supports: openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System (Regulator, edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement\_number (results\[53\]).) <https://api.fda.gov/device/pma.json?search=pma_number:%22P100045%22&limit=100>
     Locator: results\[53\].trade\_name. Retrieved 2026-10-14T18:20:06Z. Source state: Current. Snapshot hash: 85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998.
     How it applies: The trade name as the record writes it.
  5. Supports: openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System (Regulator, edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement\_number (results\[53\]).) <https://api.fda.gov/device/pma.json?search=pma_number:%22P100045%22&limit=100>
     Locator: results\[53\].ao\_statement. Retrieved 2026-10-14T18:20:06Z. Source state: Current. Snapshot hash: 85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998.
     How it applies: The approval order statement gives the indication.
  6. Supports: openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System (Regulator, edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement\_number (results\[53\]).) <https://api.fda.gov/device/pma.json?search=pma_number:%22P100045%22&limit=100>
     Locator: results\[53\].product\_code. Retrieved 2026-10-14T18:20:06Z. Source state: Current. Snapshot hash: 85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998.
     How it applies: FDA product code.
  7. Background: openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System (Regulator, edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement\_number (results\[53\]).) <https://api.fda.gov/device/pma.json?search=pma_number:%22P100045%22&limit=100>
     Locator: results\[53\].openfda.device\_class. Retrieved 2026-10-14T18:20:06Z. Source state: Current. Snapshot hash: 85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998.
     How it applies: Device class as the openFDA block writes it.
  8. Background: openFDA premarket approval (PMA) records for P100045: CardioMEMS HF Pressure Measurement System (Regulator, edition The openFDA device PMA response returned on 2026-10-14, from a dataset last updated 2026-10-05. It lists the original approval and 90 supplements; the original approval is the record with an empty supplement\_number (results\[53\]).) <https://api.fda.gov/device/pma.json?search=pma_number:%22P100045%22&limit=100>
     Locator: results\[53\].applicant. Retrieved 2026-10-14T18:20:06Z. Source state: Current. Snapshot hash: 85f5f9c64c260193a4519c1991e8ab19b5a178a33ea58952e4733cddfdf40998.
     How it applies: The applicant as the record now lists it; it does not say who held the application in 2014.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-p100045`

- Product: CardioMEMS HF System (`cardio:cardiomems-hf-system`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2014-05-28
- Product version: CardioMEMS HF System, which the approval order statement lists as the CM2000 implantable sensor and monitor with its delivery system, patient electronics and hospital electronics
- Pathway: PMA
- Submission: P100045
- Product code: MOM
- Device class: III
- Indication: Wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA class III heart failure patients who have been hospitalized for heart failure in the previous year, to inform heart failure management with the goal of reducing hospitalizations (FDA approval order statement)
- Jurisdictions: United States; note: United States
- Applies to: Recipient: Recipient not specified; Population: People with New York Heart Association class III heart failure who have been hospitalized for heart failure in the previous year, as the FDA approval order statement words the indication.; Care setting: Not stated in the FDA record beyond the indication wording.; Geography: United States (decision by the US Food and Drug Administration); Life stage: Not stated in the openFDA record. The indication wording gives no age limits.; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- Basis: claim `cardio:claim-fda-p100045-approval`

## Connected pages

- CHAMPION: fewer heart-failure hospitalisations with pressure-guided management than with standard care: Heart failure (`cardio:heart-failure`) [a claim, not a settled fact; see claim `cardio:claim-champion-hospitalization` and its context]
- Registered as a manufacturing establishment for the P100045 devices in the current openFDA listing; also the applicant on PMA P100045: Abbott (`cardio:abbott`)
- Files under this front: Devices and monitoring (`cardio:front-devices-and-monitoring`)
- Investigated in: CHAMPION trial (`cardio:champion-trial`)

## Provenance

Content hash: 4fcb92db75a316338ab6e2be8adceb12835810f585aa6bd1f34f7754954cc01a
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14