{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:cardiomems-hf-system", "owner": "cardio", "kind": "product", "slug": "cardiomems-hf-system", "name": "CardioMEMS HF System", "aliases": [ "CardioMEMS HF Pressure Measurement System" ], "atlases": [ "cardio" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [], "navigation": { "cardio": { "system": [ "heart" ], "condition-area": [ "heart-failure" ] } }, "payload": { "subtype": "device", "model_or_formulation": "CardioMEMS HF System: implantable pulmonary artery sensor and monitor, delivery system, patient electronics and hospital electronics", "version": "Not stated. The record lists many later supplements and the version under study in CHAMPION is not stated.", "intended_use_snapshots": [] }, "content_digest": "4fcb92db75a316338ab6e2be8adceb12835810f585aa6bd1f34f7754954cc01a", "review": { "content_digest": "4fcb92db75a316338ab6e2be8adceb12835810f585aa6bd1f34f7754954cc01a", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-champion-hospitalization", "owner": "cardio", "subject_entity_id": "cardio:cardiomems-hf-system", "category": "effect", "statement": "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).", "context": { "id": "cardio:ctx-champion-nyha3-us", "label": "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_note": "Adults, 18 years and over (registry minimum age). The abstract gives no mean age.", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "At least 6 months of randomized follow-up for the main comparison; mean 15 months in the whole follow-up (abstract).", "eligibility": { "inclusion": [ "NYHA class III heart failure, irrespective of ejection fraction", "Previous hospital admission for heart failure" ], "exclusion": [ "Exclusion criteria were not read; the abstract does not list them" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, FINDINGS, sentence 1", "applicability_note": "Six-month hospitalisation counts, group sizes and hazard ratio. Abstract of the paper from PubMed; the full text was not read.", "snapshot": { "id": "cardio:pubmed-21315441-2026-10-14", "retrieved_at": "2026-10-14T18:18:46Z", "content_hash": "d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:pubmed-10-1016-s0140-6736-11-60101-3", "source_type": "publication", "title": "Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial", "canonical_url": "https://doi.org/10.1016/S0140-6736(11)60101-3", "identifiers": [ { "scheme": "doi", "value": "10.1016/S0140-6736(11)60101-3", "normalized_value": "10.1016/s0140-6736(11)60101-3", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "21315441", "normalized_value": "21315441", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2011-02-19", "publisher": "Lancet (London, England)", "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.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, FINDINGS, sentence 2", "applicability_note": "Whole follow-up hospitalisation counts and hazard ratio. 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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.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, FINDINGS, sentence 3", "applicability_note": "Device-related complications and sensor failures. Abstract of the paper from PubMed; the full text was not read.", "snapshot": { "id": "cardio:pubmed-21315441-2026-10-14", "retrieved_at": "2026-10-14T18:18:46Z", "content_hash": "d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:pubmed-10-1016-s0140-6736-11-60101-3", "source_type": "publication", "title": "Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial", "canonical_url": "https://doi.org/10.1016/S0140-6736(11)60101-3", "identifiers": [ { "scheme": "doi", "value": "10.1016/S0140-6736(11)60101-3", "normalized_value": "10.1016/s0140-6736(11)60101-3", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "21315441", "normalized_value": "21315441", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2011-02-19", "publisher": "Lancet (London, England)", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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Abstract of the paper from PubMed; the full text was not read.", "snapshot": { "id": "cardio:pubmed-21315441-2026-10-14", "retrieved_at": "2026-10-14T18:18:46Z", "content_hash": "d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:pubmed-10-1016-s0140-6736-11-60101-3", "source_type": "publication", "title": "Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial", "canonical_url": "https://doi.org/10.1016/S0140-6736(11)60101-3", "identifiers": [ { "scheme": "doi", "value": "10.1016/S0140-6736(11)60101-3", "normalized_value": "10.1016/s0140-6736(11)60101-3", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "21315441", "normalized_value": "21315441", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2011-02-19", "publisher": "Lancet (London, England)", "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.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Abstract, METHODS, sentence 2", "applicability_note": "Randomization and the length of the comparison. 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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.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Abstract, METHODS, sentence 3", "applicability_note": "Only patients were masked. Abstract of the paper from PubMed; the full text was not read.", "snapshot": { "id": "cardio:pubmed-21315441-2026-10-14", "retrieved_at": "2026-10-14T18:18:46Z", "content_hash": "d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:pubmed-10-1016-s0140-6736-11-60101-3", "source_type": "publication", "title": "Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial", "canonical_url": "https://doi.org/10.1016/S0140-6736(11)60101-3", "identifiers": [ { "scheme": "doi", "value": "10.1016/S0140-6736(11)60101-3", "normalized_value": "10.1016/s0140-6736(11)60101-3", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "21315441", "normalized_value": "21315441", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2011-02-19", "publisher": "Lancet (London, England)", "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.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Abstract, METHODS, sentence 4", "applicability_note": "What the treatment group did differently. Abstract of the paper from PubMed; the full text was not read.", "snapshot": { "id": "cardio:pubmed-21315441-2026-10-14", "retrieved_at": "2026-10-14T18:18:46Z", "content_hash": "d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:pubmed-10-1016-s0140-6736-11-60101-3", "source_type": "publication", "title": "Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial", "canonical_url": "https://doi.org/10.1016/S0140-6736(11)60101-3", "identifiers": [ { "scheme": "doi", "value": "10.1016/S0140-6736(11)60101-3", "normalized_value": "10.1016/s0140-6736(11)60101-3", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "21315441", "normalized_value": "21315441", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2011-02-19", "publisher": "Lancet (London, England)", "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.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Abstract, FUNDING, sentence 1", "applicability_note": "Funder named in the abstract. Abstract of the paper from PubMed; the full text was not read.", "snapshot": { "id": "cardio:pubmed-21315441-2026-10-14", "retrieved_at": "2026-10-14T18:18:46Z", "content_hash": "d165a1c6e758a383420cd75e0dd9e145e6fd25e6dc285526981cf691e59fffb1", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:pubmed-10-1016-s0140-6736-11-60101-3", "source_type": "publication", "title": "Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial", "canonical_url": "https://doi.org/10.1016/S0140-6736(11)60101-3", "identifiers": [ { "scheme": "doi", "value": "10.1016/S0140-6736(11)60101-3", "normalized_value": "10.1016/s0140-6736(11)60101-3", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "21315441", "normalized_value": "21315441", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2011-02-19", "publisher": "Lancet (London, England)", "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.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "message.updated-by[0].DOI", "applicability_note": "Crossref lists an erratum for this paper, by DOI.", "snapshot": { "id": "cardio:crossref-champion-lancet-2011-2026-10-14", "retrieved_at": "2026-10-14T19:17:15Z", "content_hash": "b76a0476b5ad9cf55365b1463d2ff356f63acaba583a8777e58afd3913eb899b", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:crossref-champion-lancet-2011", "source_type": "dataset", "title": "Crossref record for the CHAMPION paper (10.1016/S0140-6736(11)60101-3)", "canonical_url": "https://api.crossref.org/works/10.1016/S0140-6736(11)60101-3", "identifiers": [], "publication_date": null, "publisher": "Crossref", "edition": "Crossref REST API record fetched 2026-10-14. It lists one update to the paper, an erratum.", "reuse_basis": "The Crossref terms were not read, so the reuse basis is unverified. Only the hash of the response is kept and nothing from it is quoted in a record.", "public_text": "cite_only" } } ], "review": { "content_digest": "dd0dbee0a40ba0ee2973203b67c0ba4323d855217f1045110434cddf31852244", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-champion-hospitalization.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fda-p100045-approval", "owner": "cardio", "subject_entity_id": "cardio:cardiomems-hf-system", "category": "regulatory", "statement": "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.", "context": { "id": "cardio:ctx-fda-p100045-us-approval", "label": "United States premarket approval P100045 for the CardioMEMS HF System", "recipient": "unknown", "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_note": "Not stated in the openFDA record. The indication wording gives no age limits.", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory decision)", "eligibility": { "inclusion": [ "NYHA class III heart failure", "Hospitalized for heart failure in the previous year" ], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[53].pma_number", "applicability_note": "The PMA number. 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