{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:corevalve-evolut", "owner": "cardio", "kind": "product", "slug": "corevalve-evolut", "name": "CoreValve and Evolut transcatheter valves", "aliases": [ "Medtronic CoreValve", "Evolut R", "Evolut PRO", "Evolut" ], "atlases": [ "cardio" ], "summary_plain": "A family of replacement aortic valves from Medtronic that are put in through a catheter, a procedure called TAVR. The US FDA approved the CoreValve in 2014 for people who could not have open-heart surgery or were at extreme risk, and in 2019 widened the approval for the Evolut R and Evolut PRO valves to people at low surgical risk. The Evolut Low Risk trial tested the family against surgery.", "summary_technical": "Medtronic CoreValve System (PMA P130021 original approval, 2014-01-17, extreme risk or inoperable) and the Medtronic CoreValve Evolut R and Evolut PRO systems (supplement S058, 2019-08-16, adds low surgical risk), FDA product code NPT. The Evolut Low Risk abstract describes a self-expanding supraannular bioprosthesis; its registry record names the Medtronic CoreValve System and the Medtronic CoreValve Evolut R 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" ] } }, "payload": { "subtype": "device", "model_or_formulation": "Medtronic CoreValve System; CoreValve Evolut R and Evolut PRO systems", "version": "The original approval names the CoreValve System. The 2019 supplement names the Evolut R and Evolut PRO systems. Later systems under the same PMA number are not read here.", "intended_use_snapshots": [ "cardio:openfda-pma-p130021-2026-10-14", "cardio:openfda-pma-p130021-s058-2026-10-14" ] }, "content_digest": "c971d6622ca8ec79386df9f1dcaae6fbe7e52945af7feb88496d7c01e75a8f90", "review": { "content_digest": "c971d6622ca8ec79386df9f1dcaae6fbe7e52945af7feb88496d7c01e75a8f90", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-evolut-low-risk-30-day", "owner": "cardio", "subject_entity_id": "cardio:corevalve-evolut", "category": "safety", "statement": "At 30 days in the Evolut Low Risk trial, patients who had TAVR, compared with surgery, had less disabling stroke (0.5% versus 1.7%), fewer bleeding complications (2.4% versus 7.5%), less acute kidney injury (0.9% versus 2.8%) and less atrial fibrillation (7.7% versus 35.4%). They also had more moderate or severe aortic regurgitation (blood leaking back through the aortic valve, 3.5% versus 0.5%) and more pacemaker implantation (17.4% versus 6.1%). At 12 months the valve gradient was lower with TAVR (8.6 versus 11.2 mm Hg) and the effective orifice area larger (2.3 versus 2.0 cm2).", "context": { "id": "cardio:ctx-evolut-low-risk-severe-as", "label": "Patients with severe aortic stenosis at low surgical risk, randomized in the Evolut Low Risk trial", "recipient": "unknown", "population": "Patients with severe aortic stenosis and low surgical risk, 1468 of whom were randomized. The abstract gives a mean age of 74 years. The registry lists no minimum or maximum age. The registry record also covers a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.", "care_setting": "Not stated in the abstract. The registry lists sites in the United States, Australia, Canada, France, Japan, the Netherlands and New Zealand.", "geography": "United States, Australia, Canada, France, Japan, the Netherlands and New Zealand (registry locations)", "life_stage_note": "Mean age 74 years (abstract); the registry lists 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": "The primary end point was at 24 months, analyzed when 850 patients had reached 12-month follow-up (abstract). 30-day outcomes and 12-month valve measurements are also reported. The registry gives an estimated study completion of 2029-06.", "eligibility": { "inclusion": [ "Severe aortic stenosis", "Low surgical risk" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The abstract gives these percentages without counts, intervals or tests, so no statement of significance is made here. The harms of TAVR (aortic regurgitation and pacemakers) are as important to this claim as the benefits. Funded by Medtronic. The registry lists no masking. Only the abstract was read. The 24-month result is in a separate claim.", "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": "30-day outcomes in both directions.", "snapshot": { "id": "cardio:pubmed-30883053-2026-10-14", "retrieved_at": "2026-10-14T18:18:29Z", "content_hash": "2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1816885", "source_type": "publication", "title": "Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients", "canonical_url": "https://doi.org/10.1056/NEJMoa1816885", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1816885", "normalized_value": "10.1056/nejmoa1816885", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30883053", "normalized_value": "30883053", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2019-05-02", "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 5", "applicability_note": "12-month valve gradient and orifice area.", "snapshot": { "id": "cardio:pubmed-30883053-2026-10-14", "retrieved_at": "2026-10-14T18:18:29Z", "content_hash": "2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1816885", "source_type": "publication", "title": "Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients", "canonical_url": "https://doi.org/10.1056/NEJMoa1816885", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1816885", "normalized_value": "10.1056/nejmoa1816885", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30883053", "normalized_value": "30883053", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2019-05-02", "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" } } ], "review": { "content_digest": "03e0ad1b760b78e5ffbb708eb42a27086356df22169022e83b4d85e357b05f99", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-evolut-low-risk-30-day.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-evolut-low-risk-primary", "owner": "cardio", "subject_entity_id": "cardio:corevalve-evolut", "category": "effect", "statement": "In the Evolut Low Risk trial, 1468 patients with severe aortic stenosis and low surgical risk were randomized to TAVR with a self-expanding valve or to surgery. At 24 months the estimated rate of death or disabling stroke was 5.3% with TAVR and 6.7% with surgery (a difference of -1.4 percentage points; 95% Bayesian credible interval for the difference -4.9 to 2.1; posterior probability of noninferiority above 0.999). The authors conclude TAVR was noninferior to surgery. The abstract reports a noninferiority result only and no test of superiority.", "context": { "id": "cardio:ctx-evolut-low-risk-severe-as", "label": "Patients with severe aortic stenosis at low surgical risk, randomized in the Evolut Low Risk trial", "recipient": "unknown", "population": "Patients with severe aortic stenosis and low surgical risk, 1468 of whom were randomized. The abstract gives a mean age of 74 years. The registry lists no minimum or maximum age. The registry record also covers a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.", "care_setting": "Not stated in the abstract. The registry lists sites in the United States, Australia, Canada, France, Japan, the Netherlands and New Zealand.", "geography": "United States, Australia, Canada, France, Japan, the Netherlands and New Zealand (registry locations)", "life_stage_note": "Mean age 74 years (abstract); the registry lists 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": "The primary end point was at 24 months, analyzed when 850 patients had reached 12-month follow-up (abstract). 30-day outcomes and 12-month valve measurements are also reported. The registry gives an estimated study completion of 2029-06.", "eligibility": { "inclusion": [ "Severe aortic stenosis", "Low surgical risk" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Funded by Medtronic; the registry lists Medtronic Cardiovascular as lead sponsor and FDA lists Medtronic, Inc. as applicant for the valve. The registry lists no masking. The result is a noninferiority result from a Bayesian analysis done when 850 patients had reached 12-month follow-up; it is not a statement that TAVR lowers events. Results are for one self-expanding valve in selected low-risk patients and do not extend to other valves or to higher-risk patients. Only the abstract was read: the NEJM page was not fetched for this paper, and PubMed lists no open full text. The 30-day harms are in a separate claim and should be read with this one.", "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 3", "applicability_note": "24-month rates of the primary end point, the difference, the credible interval and the probability of noninferiority.", "snapshot": { "id": "cardio:pubmed-30883053-2026-10-14", "retrieved_at": "2026-10-14T18:18:29Z", "content_hash": "2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1816885", "source_type": "publication", "title": "Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients", "canonical_url": "https://doi.org/10.1056/NEJMoa1816885", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1816885", "normalized_value": "10.1056/nejmoa1816885", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30883053", "normalized_value": "30883053", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2019-05-02", "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 conclude noninferiority.", "snapshot": { "id": "cardio:pubmed-30883053-2026-10-14", "retrieved_at": "2026-10-14T18:18:29Z", "content_hash": "2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1816885", "source_type": "publication", "title": "Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients", "canonical_url": "https://doi.org/10.1056/NEJMoa1816885", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1816885", "normalized_value": "10.1056/nejmoa1816885", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30883053", "normalized_value": "30883053", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2019-05-02", "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 and 2", "applicability_note": "Design, population and the Bayesian analysis of the 24-month end point.", "snapshot": { "id": "cardio:pubmed-30883053-2026-10-14", "retrieved_at": "2026-10-14T18:18:29Z", "content_hash": "2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1816885", "source_type": "publication", "title": "Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients", "canonical_url": "https://doi.org/10.1056/NEJMoa1816885", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1816885", "normalized_value": "10.1056/nejmoa1816885", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30883053", "normalized_value": "30883053", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2019-05-02", "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, RESULTS, sentences 1 and 2", "applicability_note": "Number randomized and mean age.", "snapshot": { "id": "cardio:pubmed-30883053-2026-10-14", "retrieved_at": "2026-10-14T18:18:29Z", "content_hash": "2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1816885", "source_type": "publication", "title": "Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients", "canonical_url": "https://doi.org/10.1056/NEJMoa1816885", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1816885", "normalized_value": "10.1056/nejmoa1816885", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30883053", "normalized_value": "30883053", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2019-05-02", "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-nct02701283-2026-10-14", "retrieved_at": "2026-10-14T18:18:26Z", "content_hash": "bd30fbe5fbcc66a1a6b6a87329c13591d0f40b947c57fbbe55d5aa866879c467", "source_effective_date": "2026-05-07", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:ctgov-nct02701283", "source_type": "registry", "title": "Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients", "canonical_url": "https://clinicaltrials.gov/study/NCT02701283", "identifiers": [ { "scheme": "nct", "value": "NCT02701283", "normalized_value": "NCT02701283", "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 2026-05-07.", "reuse_basis": "Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT02701283.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": "82b5a37aaed1413a3d31fbfdb46e1bb04233b71cfd0d15aeb9cf0205c32b2d6f", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-evolut-low-risk-primary.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fda-p130021-approval", "owner": "cardio", "subject_entity_id": "cardio:corevalve-evolut", "category": "regulatory", "statement": "On 2014-01-17 the US Food and Drug Administration approved the Medtronic CoreValve System under PMA P130021, product code NPT, applicant Medtronic, Inc. According to the approval order, the system is for easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whose native aortic annulus measures 18 to 29 mm across, and whom a heart team that includes a cardiac surgeon judges to be at extreme risk with open surgery or unable to have it. The summary of safety and effectiveness defines severe stenosis as an aortic valve area of 0.8 cm2 or less, or a mean aortic valve gradient above 40 mmHg, or a peak velocity of the aortic jet above 4.0 m/s, and it describes extreme risk as a predicted risk of operative death, of serious irreversible morbidity, or of both, of 50% or more at 30 days. openFDA prints a question mark in place of those two comparison symbols, so the readings come from the summary.", "context": { "id": "cardio:ctx-fda-p130021-extreme-risk-severe-as", "label": "United States PMA approval P130021: CoreValve for severe aortic stenosis at extreme risk or inoperable", "recipient": "unknown", "population": "People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, with a native aortic annulus 18 to 29 mm across, whom a heart team that includes a cardiac surgeon judges to be at extreme risk with open surgery or unable to have it. 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": [ "Heart disease with symptoms caused by severe calcific narrowing of the person's own (native) aortic valve", "Native aortic annulus 18 to 29 mm across", "A heart team that includes a cardiac surgeon judges the person to be at extreme risk with open surgery or unable to have it" ], "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 extreme risk or inoperable patients only. The low-risk supplement S058 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-p130021-2026-10-14", "retrieved_at": "2026-10-14T18:21:09Z", "content_hash": "57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p130021", "source_type": "regulator", "title": "FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P130021&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P130021", "normalized_value": "P130021", "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 P130021 (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-P130021.json. The record gives the applicant's street address; records here do not repeat it. 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The supplement widens the use of these systems to people for whom the risk of surgical aortic valve replacement is low. The use it describes is easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement.", "context": { "id": "cardio:ctx-fda-p130021-s058-low-risk-severe-as", "label": "United States PMA supplement P130021 S058: Evolut R and Evolut PRO for severe aortic stenosis at low surgical risk", "recipient": "unknown", "population": "People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement, including people for whom the risk of surgical aortic valve replacement is low. 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": [ "Heart disease with symptoms caused by severe calcific narrowing of the person's own (native) aortic valve", "A heart team that includes a cardiac surgeon judges transcatheter heart valve replacement suitable for the person" ], "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. 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