{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:mitraclip", "owner": "cardio", "kind": "product", "slug": "mitraclip", "name": "MitraClip", "aliases": [ "MitraClip NT", "MitraClip NTR/XTR", "MitraClip System" ], "atlases": [ "cardio" ], "summary_plain": "A device from Abbott for leaky mitral valves. It is delivered through a catheter and is a form of transcatheter edge-to-edge repair. The US FDA approved it in 2013 for people with a degenerative leak who are at prohibitive risk for surgery, and in 2019 added people with a moderate-to-severe or severe leak caused by heart muscle weakness (secondary mitral regurgitation), a left ventricular ejection fraction from 20% to 50%, both included, and an end-systolic dimension of the left ventricle of 70 mm or less, whose symptoms continue despite the fullest guideline-directed medical therapy they tolerate, as judged by a heart team. The COAPT trial tested it in that second group.", "summary_technical": "MitraClip Clip Delivery System, FDA product code NKM. PMA P100009 original approval 2013-10-24 (degenerative mitral regurgitation, prohibitive surgical risk); supplement S028, 2019-03-14, for the MitraClip NT and NTR/XTR Clip Delivery Systems, adds symptomatic moderate-to-severe or severe secondary mitral regurgitation in people who also take the fullest guideline-directed medical therapy they tolerate. COAPT registry NCT01626079 names the intervention MitraClip System. Later systems under the same PMA number are not read here.", "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": [ "valvular-and-congenital-disease", "heart-failure" ] } }, "payload": { "subtype": "device", "model_or_formulation": "MitraClip Clip Delivery System; MitraClip NT and NTR/XTR Clip Delivery Systems", "version": "The original approval names the MitraClip Clip Delivery System. The 2019 supplement names the NT and NTR/XTR systems. Later systems under the same PMA number are not read here.", "intended_use_snapshots": [ "cardio:openfda-pma-p100009-2026-10-14", "cardio:openfda-pma-p100009-s028-2026-10-14" ] }, "content_digest": "7c31f1e3e0eaebce050eaa9d0612e0362e5318f3ad9dce0bd36855d040e18a61", "review": { "content_digest": "7c31f1e3e0eaebce050eaa9d0612e0362e5318f3ad9dce0bd36855d040e18a61", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-coapt-all-cause-death", "owner": "cardio", "subject_entity_id": "cardio:mitraclip", "category": "effect", "statement": "In COAPT, death from any cause within 24 months occurred in 29.1% of the patients in the MitraClip plus medicines group and in 46.1% of the patients in the medicines alone group (hazard ratio 0.62, 95% confidence interval 0.46 to 0.82).", "context": { "id": "cardio:ctx-coapt-hf-secondary-mr", "label": "Adults with heart failure and moderate-to-severe or severe secondary mitral regurgitation, randomized in COAPT", "recipient": "adult", "population": "Patients 18 years or older (registry minimum age) with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy; 614 were randomized (302 to the device group and 312 to the control group). The registry record also covers a continued access study of 162 further patients. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.", "care_setting": "78 sites in the United States and Canada (abstract)", "geography": "United States and Canada", "life_stage_note": "Registry minimum age 18 years; no maximum 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": "The primary effectiveness end point covers 24 months; the primary safety end point is at 12 months (abstract). The registry gives the primary completion as 2019-03 and an estimated study completion of 2024-07, with a recruitment status of unknown.", "eligibility": { "inclusion": [ "Heart failure with moderate-to-severe or severe secondary mitral regurgitation", "Symptoms despite maximal doses of guideline-directed medical therapy", "Age 18 years or older (registry)" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The abstract does not name death from any cause among the end points in its methods; it reports 24-month death as a result. The registry lists all-cause mortality among its secondary outcomes (a count at 12 months, and Kaplan-Meier freedom from all-cause mortality at 24 months). The abstract does not say whether this test was prespecified or adjusted for multiple comparisons, so treat it as a secondary result. The same limits apply as for the heart-failure hospitalization claim: funded by Abbott, no masking in the registry, selected patients with secondary mitral regurgitation on maximal medicines. Only the abstract was read.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 4", "applicability_note": "Death from any cause by group, and the hazard ratio.", "snapshot": { "id": "cardio:pubmed-30280640-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1806640", "source_type": "publication", "title": "Transcatheter Mitral-Valve Repair in Patients with Heart Failure", "canonical_url": "https://doi.org/10.1056/NEJMoa1806640", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1806640", "normalized_value": "10.1056/nejmoa1806640", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30280640", "normalized_value": "30280640", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-12-13", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried.", "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 (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, CONCLUSIONS, sentence 1", "applicability_note": "The authors report lower all-cause mortality within 24 months.", "snapshot": { "id": "cardio:pubmed-30280640-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1806640", "source_type": "publication", "title": "Transcatheter Mitral-Valve Repair in Patients with Heart Failure", "canonical_url": "https://doi.org/10.1056/NEJMoa1806640", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1806640", "normalized_value": "10.1056/nejmoa1806640", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30280640", "normalized_value": "30280640", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-12-13", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried.", "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 (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "protocolSection.outcomesModule.secondaryOutcomes[24].measure", "applicability_note": "The registry lists all-cause mortality at 12 months among its secondary outcomes.", "snapshot": { "id": "cardio:ctgov-nct01626079-2026-10-14", "retrieved_at": "2026-10-14T18:18:23Z", "content_hash": "c704470d9e281e9b6ab5a19cc4735faa44c97e48e3d57e3fbc41ed6c84710da1", "source_effective_date": "2023-11-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:ctgov-nct01626079", "source_type": "registry", "title": "Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS", "canonical_url": "https://clinicaltrials.gov/study/NCT01626079", "identifiers": [ { "scheme": "nct", "value": "NCT01626079", "normalized_value": "NCT01626079", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. National Library of Medicine (ClinicalTrials.gov)", "edition": "ClinicalTrials.gov API v2 record, last update posted 2023-11-27.", "reuse_basis": "Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT01626079.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "protocolSection.outcomesModule.secondaryOutcomes[48].measure", "applicability_note": "The registry also lists Kaplan-Meier freedom from all-cause mortality as a secondary outcome.", "snapshot": { "id": "cardio:ctgov-nct01626079-2026-10-14", "retrieved_at": "2026-10-14T18:18:23Z", "content_hash": "c704470d9e281e9b6ab5a19cc4735faa44c97e48e3d57e3fbc41ed6c84710da1", "source_effective_date": "2023-11-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:ctgov-nct01626079", "source_type": "registry", "title": "Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS", "canonical_url": "https://clinicaltrials.gov/study/NCT01626079", "identifiers": [ { "scheme": "nct", "value": "NCT01626079", "normalized_value": "NCT01626079", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. National Library of Medicine (ClinicalTrials.gov)", "edition": "ClinicalTrials.gov API v2 record, last update posted 2023-11-27.", "reuse_basis": "Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT01626079.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.", "public_text": "quote" } } ], "review": { "content_digest": "41af2169681c3a0e2c988e2230f5eec60556bb832ad9e8b5c4e83896caf7cb90", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-coapt-all-cause-death.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-coapt-hf-hospitalization", "owner": "cardio", "subject_entity_id": "cardio:mitraclip", "category": "effect", "statement": "In COAPT, 614 patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who were still symptomatic on maximal medicines were randomized at 78 sites in the United States and Canada to the MitraClip device plus medicines (302 patients) or medicines alone (312 patients). The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year with the device and 67.9% per patient-year with medicines alone (hazard ratio 0.53, 95% confidence interval 0.40 to 0.70). The primary safety end point, freedom from device-related complications at 12 months, was 96.6% (lower 95% confidence limit 94.8%), above the prespecified goal of 88.0%.", "context": { "id": "cardio:ctx-coapt-hf-secondary-mr", "label": "Adults with heart failure and moderate-to-severe or severe secondary mitral regurgitation, randomized in COAPT", "recipient": "adult", "population": "Patients 18 years or older (registry minimum age) with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy; 614 were randomized (302 to the device group and 312 to the control group). The registry record also covers a continued access study of 162 further patients. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.", "care_setting": "78 sites in the United States and Canada (abstract)", "geography": "United States and Canada", "life_stage_note": "Registry minimum age 18 years; no maximum 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": "The primary effectiveness end point covers 24 months; the primary safety end point is at 12 months (abstract). The registry gives the primary completion as 2019-03 and an estimated study completion of 2024-07, with a recruitment status of unknown.", "eligibility": { "inclusion": [ "Heart failure with moderate-to-severe or severe secondary mitral regurgitation", "Symptoms despite maximal doses of guideline-directed medical therapy", "Age 18 years or older (registry)" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Funded by Abbott; the registry lists Abbott Medical Devices as lead sponsor and FDA lists ABBOTT MEDICAL as applicant for the device. The registry lists no masking. The result applies to the group enrolled: symptomatic heart failure with secondary mitral regurgitation despite maximal medicines. It does not show the same effect in people with primary (degenerative) mitral regurgitation or in people who are not on maximal medicines. Other trials of the same device in similar patients are not covered in this record. The registry shows a recruitment status of unknown with an estimated completion in 2024-07, which is out of date. Only the abstract was read.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 2", "applicability_note": "Annualized rate of heart-failure hospitalization by group, and the hazard ratio.", "snapshot": { "id": "cardio:pubmed-30280640-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1806640", "source_type": "publication", "title": "Transcatheter Mitral-Valve Repair in Patients with Heart Failure", "canonical_url": "https://doi.org/10.1056/NEJMoa1806640", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1806640", "normalized_value": "10.1056/nejmoa1806640", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30280640", "normalized_value": "30280640", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-12-13", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried.", "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 (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 3", "applicability_note": "Primary safety end point.", "snapshot": { "id": "cardio:pubmed-30280640-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1806640", "source_type": "publication", "title": "Transcatheter Mitral-Valve Repair in Patients with Heart Failure", "canonical_url": "https://doi.org/10.1056/NEJMoa1806640", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1806640", "normalized_value": "10.1056/nejmoa1806640", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30280640", "normalized_value": "30280640", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-12-13", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried.", "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 (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, CONCLUSIONS, sentences 1 and 2", "applicability_note": "The authors' conclusion for the same population.", "snapshot": { "id": "cardio:pubmed-30280640-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1806640", "source_type": "publication", "title": "Transcatheter Mitral-Valve Repair in Patients with Heart Failure", "canonical_url": "https://doi.org/10.1056/NEJMoa1806640", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1806640", "normalized_value": "10.1056/nejmoa1806640", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30280640", "normalized_value": "30280640", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-12-13", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried.", "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 (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Abstract, METHODS, sentences 1 to 4", "applicability_note": "Design, sites, population and end points.", "snapshot": { "id": "cardio:pubmed-30280640-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1806640", "source_type": "publication", "title": "Transcatheter Mitral-Valve Repair in Patients with Heart Failure", "canonical_url": "https://doi.org/10.1056/NEJMoa1806640", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1806640", "normalized_value": "10.1056/nejmoa1806640", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30280640", "normalized_value": "30280640", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-12-13", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried.", "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 (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "protocolSection.designModule.designInfo.maskingInfo.masking", "applicability_note": "The registry records no masking.", "snapshot": { "id": "cardio:ctgov-nct01626079-2026-10-14", "retrieved_at": "2026-10-14T18:18:23Z", "content_hash": "c704470d9e281e9b6ab5a19cc4735faa44c97e48e3d57e3fbc41ed6c84710da1", "source_effective_date": "2023-11-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:ctgov-nct01626079", "source_type": "registry", "title": "Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS", "canonical_url": "https://clinicaltrials.gov/study/NCT01626079", "identifiers": [ { "scheme": "nct", "value": "NCT01626079", "normalized_value": "NCT01626079", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. National Library of Medicine (ClinicalTrials.gov)", "edition": "ClinicalTrials.gov API v2 record, last update posted 2023-11-27.", "reuse_basis": "Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT01626079.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.", "public_text": "quote" } } ], "review": { "content_digest": "5a3fbc14e0e0ce152d3eaf5ad22b88a292cf86489bb4f5c34138858784f13d0a", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-coapt-hf-hospitalization.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fda-p100009-approval", "owner": "cardio", "subject_entity_id": "cardio:mitraclip", "category": "regulatory", "statement": "On 2013-10-24 the US Food and Drug Administration approved the MitraClip Clip Delivery System under PMA P100009, product code NKM, applicant ABBOTT MEDICAL. The approval order states the use as percutaneous reduction of significant symptomatic mitral regurgitation (MR of 3+ or more) due to a primary abnormality of the mitral apparatus (degenerative MR) in patients determined by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, to be at prohibitive risk for mitral valve surgery, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.", "context": { "id": "cardio:ctx-fda-p100009-degenerative-mr-prohibitive-risk", "label": "United States PMA approval P100009: MitraClip for degenerative mitral regurgitation at prohibitive surgical risk", "recipient": "unknown", "population": "Patients with significant symptomatic mitral regurgitation (MR of grade 3+ or more) due to a primary abnormality of the mitral apparatus (degenerative MR) whom a heart team, including a cardiac surgeon and a cardiologist experienced in mitral valve disease, judges to be at prohibitive risk for mitral valve surgery, and in whom existing comorbidities would not preclude the expected benefit. The order gives no age range.", "care_setting": "Not stated in the FDA record beyond the heart team judgement", "geography": "United States (decision by the US Food and Drug Administration)", "life_stage_note": "Not stated in the FDA record", "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": [ "Significant symptomatic mitral regurgitation (3+ or more) due to a primary abnormality of the mitral apparatus (degenerative MR)", "Judged by a heart team to be at prohibitive risk for mitral valve surgery", "Existing comorbidities would not preclude the expected benefit" ], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. This original approval covers degenerative mitral regurgitation only. Secondary mitral regurgitation, the group studied in COAPT, was added by supplement S028, which has its own record.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].pma_number", "applicability_note": "The PMA number of this record.", "snapshot": { "id": "cardio:openfda-pma-p100009-2026-10-14", "retrieved_at": "2026-10-14T18:21:10Z", "content_hash": "b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009", "source_type": "regulator", "title": "FDA premarket approval record P100009: MitraClip Clip Delivery System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P100009", "normalized_value": "P100009", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].applicant", "applicability_note": "The applicant, as FDA writes the name.", "snapshot": { "id": "cardio:openfda-pma-p100009-2026-10-14", "retrieved_at": "2026-10-14T18:21:10Z", "content_hash": "b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009", "source_type": "regulator", "title": "FDA premarket approval record P100009: MitraClip Clip Delivery System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P100009", "normalized_value": "P100009", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].trade_name", "applicability_note": "The trade name FDA gives this record.", "snapshot": { "id": "cardio:openfda-pma-p100009-2026-10-14", "retrieved_at": "2026-10-14T18:21:10Z", "content_hash": "b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009", "source_type": "regulator", "title": "FDA premarket approval record P100009: MitraClip Clip Delivery System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P100009", "normalized_value": "P100009", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_date", "applicability_note": "ISO date of the decision.", "snapshot": { "id": "cardio:openfda-pma-p100009-2026-10-14", "retrieved_at": "2026-10-14T18:21:10Z", "content_hash": "b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009", "source_type": "regulator", "title": "FDA premarket approval record P100009: MitraClip Clip Delivery System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P100009", "normalized_value": "P100009", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_code", "applicability_note": "FDA decision code: APPR is an approval.", "snapshot": { "id": "cardio:openfda-pma-p100009-2026-10-14", "retrieved_at": "2026-10-14T18:21:10Z", "content_hash": "b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009", "source_type": "regulator", "title": "FDA premarket approval record P100009: MitraClip Clip Delivery System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P100009", "normalized_value": "P100009", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code", "applicability_note": "FDA product code of this record.", "snapshot": { "id": "cardio:openfda-pma-p100009-2026-10-14", "retrieved_at": "2026-10-14T18:21:10Z", "content_hash": "b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009", "source_type": "regulator", "title": "FDA premarket approval record P100009: MitraClip Clip Delivery System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P100009", "normalized_value": "P100009", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].ao_statement", "applicability_note": "FDA approval order statement: the approved indication, quoted in fragments.", "snapshot": { "id": "cardio:openfda-pma-p100009-2026-10-14", "retrieved_at": "2026-10-14T18:21:10Z", "content_hash": "b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009", "source_type": "regulator", "title": "FDA premarket approval record P100009: MitraClip Clip Delivery System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P100009", "normalized_value": "P100009", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "meta.disclaimer", "applicability_note": "openFDA's own disclaimer about relying on its data.", "snapshot": { "id": "cardio:openfda-pma-p100009-2026-10-14", "retrieved_at": "2026-10-14T18:21:10Z", "content_hash": "b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009", "source_type": "regulator", "title": "FDA premarket approval record P100009: MitraClip Clip Delivery System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P100009", "normalized_value": "P100009", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } } ], "review": { "content_digest": "c6d16ccbc02e2261aba88dd2300a9cee17f89d925e98ee7fa6fd15ff50b1c290", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-fda-p100009-approval.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fda-p100009-s028-secondary-mr", "owner": "cardio", "subject_entity_id": "cardio:mitraclip", "category": "regulatory", "statement": "On 2019-03-14 the US Food and Drug Administration approved PMA supplement S028 to P100009, applicant ABBOTT MEDICAL. The supplement covers the MitraClip NT Clip Delivery System together with the MitraClip NTR/XTR Clip Delivery System, and it adds secondary mitral regurgitation to the uses. The approved use is to be used together with the fullest guideline-directed medical therapy the person tolerates, in people who have symptoms from secondary (functional) mitral regurgitation graded moderate-to-severe or severe, a left ventricular ejection fraction from 20% to 50%, both included, and an end-systolic dimension of the left ventricle of 70 mm or less, and whose symptoms and regurgitation remain despite that therapy, as judged by a multidisciplinary heart team.", "context": { "id": "cardio:ctx-fda-p100009-s028-secondary-mr-heart-failure", "label": "United States PMA supplement P100009 S028: MitraClip for secondary mitral regurgitation", "recipient": "unknown", "population": "People with symptomatic secondary (functional) mitral regurgitation graded moderate-to-severe or severe (grade III or more by American Society of Echocardiography criteria), a left ventricular ejection fraction from 20% to 50%, both included, and an end-systolic dimension of the left ventricle of 70 mm or less, whose symptoms and regurgitation continue despite the fullest guideline-directed medical therapy the person tolerates, as judged by a multidisciplinary team of heart specialists with experience in heart failure and mitral valve disease. The order gives no age range.", "care_setting": "A heart team drawn from several specialties, with experience in heart failure and mitral valve disease, makes the call (the order's requirement, paraphrased)", "geography": "United States (decision by the US Food and Drug Administration)", "life_stage_note": "Not stated in the FDA record", "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": [ "Symptomatic moderate-to-severe or severe secondary mitral regurgitation (grade III or more)", "Left ventricular ejection fraction from 20% to 50%, both included", "End-systolic dimension of the left ventricle of 70 mm or less", "Symptoms and regurgitation continue despite the fullest guideline-directed medical therapy the person tolerates" ], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. The openFDA record does not name the trial behind the supplement, so this record does not link the supplement to COAPT.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].pma_number", "applicability_note": "The PMA number of this record.", "snapshot": { "id": "cardio:openfda-pma-p100009-s028-2026-10-14", "retrieved_at": "2026-10-14T18:21:18Z", "content_hash": "13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009-s028", "source_type": "regulator", "title": "FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009+AND+supplement_number:S028&limit=1", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009-S028.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].supplement_number", "applicability_note": "The supplement number of this record.", "snapshot": { "id": "cardio:openfda-pma-p100009-s028-2026-10-14", "retrieved_at": "2026-10-14T18:21:18Z", "content_hash": "13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009-s028", "source_type": "regulator", "title": "FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009+AND+supplement_number:S028&limit=1", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009-S028.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].applicant", "applicability_note": "The applicant, as FDA writes the name.", "snapshot": { "id": "cardio:openfda-pma-p100009-s028-2026-10-14", "retrieved_at": "2026-10-14T18:21:18Z", "content_hash": "13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009-s028", "source_type": "regulator", "title": "FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009+AND+supplement_number:S028&limit=1", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009-S028.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].trade_name", "applicability_note": "The trade name FDA gives this record.", "snapshot": { "id": "cardio:openfda-pma-p100009-s028-2026-10-14", "retrieved_at": "2026-10-14T18:21:18Z", "content_hash": "13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009-s028", "source_type": "regulator", "title": "FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009+AND+supplement_number:S028&limit=1", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009-S028.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_date", "applicability_note": "ISO date of the decision.", "snapshot": { "id": "cardio:openfda-pma-p100009-s028-2026-10-14", "retrieved_at": "2026-10-14T18:21:18Z", "content_hash": "13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009-s028", "source_type": "regulator", "title": "FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009+AND+supplement_number:S028&limit=1", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009-S028.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_code", "applicability_note": "FDA decision code: APPR is an approval.", "snapshot": { "id": "cardio:openfda-pma-p100009-s028-2026-10-14", "retrieved_at": "2026-10-14T18:21:18Z", "content_hash": "13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009-s028", "source_type": "regulator", "title": "FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009+AND+supplement_number:S028&limit=1", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009-S028.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code", "applicability_note": "FDA product code of this record.", "snapshot": { "id": "cardio:openfda-pma-p100009-s028-2026-10-14", "retrieved_at": "2026-10-14T18:21:18Z", "content_hash": "13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009-s028", "source_type": "regulator", "title": "FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009+AND+supplement_number:S028&limit=1", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009-S028.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].ao_statement", "applicability_note": "FDA approval order statement: the approved indication, quoted in fragments.", "snapshot": { "id": "cardio:openfda-pma-p100009-s028-2026-10-14", "retrieved_at": "2026-10-14T18:21:18Z", "content_hash": "13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009-s028", "source_type": "regulator", "title": "FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009+AND+supplement_number:S028&limit=1", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009-S028.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "meta.disclaimer", "applicability_note": "openFDA's own disclaimer about relying on its data.", "snapshot": { "id": "cardio:openfda-pma-p100009-s028-2026-10-14", "retrieved_at": "2026-10-14T18:21:18Z", "content_hash": "13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p100009-s028", "source_type": "regulator", "title": "FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P100009+AND+supplement_number:S028&limit=1", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.", "reuse_basis": "openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P100009-S028.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "page 1, Re: line", "applicability_note": "The FDA approval order names the supplement as P100009/S028.", "snapshot": { "id": "cardio:fda-p100009-s028-order-2026-10-14", "retrieved_at": "2026-10-14T19:20:12Z", "content_hash": "9f32bc5b9932239acb871ef7ca9ae9513c7b8608f4df8d8ffa0d36dafdc795f8", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-p100009-s028-order", "source_type": "regulator", "title": "FDA approval order for PMA supplement P100009/S028 (MitraClip, secondary mitral regurgitation)", "canonical_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100009S028A.pdf", "identifiers": [ { "scheme": "fda-pma", "value": "P100009/S028", "normalized_value": "P100009/S028", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration", "edition": "PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.", "reuse_basis": "FDA document fetched 2026-10-14 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed.", "public_text": "cite_only" } } ], "review": { "content_digest": "886ef4952c983ba40e9a45f7f3fafe2f1bc347cd14041da3db12a0b7970fada3", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-fda-p100009-s028-secondary-mr.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "cardio:regdec-fda-p100009-s028", "product_id": "cardio:mitraclip", "product_version": "MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028)", "indication": "PMA supplement S028 expands the indication to include symptomatic moderate-to-severe or severe secondary (functional) mitral regurgitation (grade III or more) in patients with a left ventricular ejection fraction of 20% to 50% and a left ventricular end systolic dimension of 70 mm or less, whose symptoms and mitral regurgitation persist despite maximally tolerated guideline-directed medical therapy, as determined by a multidisciplinary heart team experienced in heart failure and mitral valve disease.", "context_id": "cardio:ctx-fda-p100009-s028-secondary-mr-heart-failure", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "supplemental_approval", "recall_class": null, "submission_id": "P100009/S028", "pathway": "pma", "product_code": "NKM", "device_class": "III", "decision_date": "2019-03-14", "valid_to": null, "claim_id": "cardio:claim-fda-p100009-s028-secondary-mr" }, { "type": "regulatory_decision", "id": "cardio:regdec-fda-p100009", "product_id": "cardio:mitraclip", "product_version": "MitraClip Clip Delivery System (original approval)", "indication": "Percutaneous reduction of significant symptomatic degenerative mitral regurgitation (MR of 3+ or more) in patients a heart team judges to be at prohibitive risk for mitral valve surgery, and in whom existing comorbidities would not preclude the expected benefit.", "context_id": "cardio:ctx-fda-p100009-degenerative-mr-prohibitive-risk", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "approval", "recall_class": null, "submission_id": "P100009", "pathway": "pma", "product_code": "NKM", "device_class": "III", "decision_date": "2013-10-24", "valid_to": null, "claim_id": "cardio:claim-fda-p100009-approval" } ], "milestones": [], "relationships": { "outgoing": [ { "predicate": "manufactured_by", "label": "Applicant on P100009 is ABBOTT MEDICAL; the sources read do not say who makes the device", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "cardio:abbott", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "cardio:openfda-pma-p100009-2026-10-14", "locator": "results[0].applicant" }, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "uses_technology", "label": "A transcatheter edge-to-edge repair device", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "cardio:transcatheter-edge-to-edge-repair", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "evaluated_for", "label": "COAPT: fewer heart-failure hospitalizations with the clip plus medicines than with medicines alone, in secondary mitral regurgitation", "clinical_claim_not_fact": true, "family": "clinical", "other_entity_id": "cardio:mitral-regurgitation", "other_entity_in_atlas": true, "claim_id": "cardio:claim-coapt-hf-hospitalization", "evidence": null, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "evaluated_for", "label": "COAPT: lower death from any cause within 24 months with the clip plus medicines", "clinical_claim_not_fact": true, "family": "clinical", "other_entity_id": "cardio:mitral-regurgitation", "other_entity_in_atlas": true, "claim_id": "cardio:claim-coapt-all-cause-death", "evidence": null, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "part_of", "label": "Filed under this front", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "cardio:front-procedures-and-surgery", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": true, "role": null, "valid_from": null, "valid_to": null } ], "incoming": [ { "predicate": "investigates", "label": "Investigated in", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "cardio:coapt", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "cardio:ctgov-nct01626079-2026-10-14", "locator": "protocolSection.armsInterventionsModule.interventions[0].name" }, "primary": false, "role": null, "valid_from": null, "valid_to": null } ] }, "page_path": "products/mitraclip/", "context_path": "api/v1/context/cardio--mitraclip.md" }