{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:sapien-3", "owner": "cardio", "kind": "product", "slug": "sapien-3", "name": "SAPIEN 3 transcatheter heart valve", "aliases": [ "Edwards SAPIEN 3", "SAPIEN 3 Ultra", "SAPIEN 3 THV" ], "atlases": [ "cardio" ], "summary_plain": "A replacement aortic valve from Edwards Lifesciences that is put in through a catheter, a procedure called TAVR. The US FDA approved it in 2015 for people with severe aortic stenosis who a heart team judged to be at high or greater risk from open-heart surgery, and in 2019 widened the approval to people at low surgical risk. It is the valve tested in the PARTNER 3 and EARLY TAVR trials.", "summary_technical": "Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves, FDA product code NPT. Original approval: PMA P140031, 2015-06-17, model 9600TFX and accessories, high or greater surgical risk. Supplement S085, 2019-08-16, names the SAPIEN 3 and SAPIEN 3 Ultra systems and adds people for whom the risk of surgical aortic valve replacement is low. The PARTNER 3 and EARLY TAVR abstracts describe a balloon-expandable valve placed through the femoral artery; the EARLY TAVR registry record names the SAPIEN 3 and SAPIEN 3 Ultra valves. Between the two approvals FDA made many other supplements that 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": "SAPIEN 3 (model 9600TFX in the original approval) and SAPIEN 3 Ultra", "version": "The original approval names model 9600TFX and accessories. The 2019 supplement names the SAPIEN 3 and SAPIEN 3 Ultra systems. Other models and supplements are not read here.", "intended_use_snapshots": [ "cardio:openfda-pma-p140031-2026-10-14", "cardio:openfda-pma-p140031-s085-2026-10-14" ] }, "content_digest": "91727267cc48895bb12ceb9dd406729efdd88d136fd502c5363d182df44b80b6", "review": { "content_digest": "91727267cc48895bb12ceb9dd406729efdd88d136fd502c5363d182df44b80b6", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fda-p140031-approval", "owner": "cardio", "subject_entity_id": "cardio:sapien-3", "category": "regulatory", "statement": "On 2015-06-17 the US Food and Drug Administration approved the Edwards SAPIEN 3 transcatheter heart valve, model 9600TFX, and its accessories under PMA P140031, product code NPT, applicant Edwards Lifesciences, LLC. According to the approval order, the valve is for 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 to face a high or greater risk from open surgery. The summary of safety and effectiveness gives the measure of that risk as a Society of Thoracic Surgeons operative risk score of 8% or more, or a risk of mortality at 30 days of 15% or more. The openFDA text of the order prints no comparison symbol, so those readings come from the summary.", "context": { "id": "cardio:ctx-fda-p140031-high-risk-severe-as", "label": "United States PMA approval P140031: SAPIEN 3 for severe aortic stenosis at high or greater 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 to face a high or greater risk from open surgery. 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 the person to face a high or greater risk from open surgery (Society of Thoracic Surgeons operative risk score of 8% or more, or a risk of mortality at 30 days of 15% or more, per the summary of safety and effectiveness)" ], "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 high or greater surgical risk only. Later supplements widened the indication (the low-risk supplement S085 has its own record; other supplements are not read here).", "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-p140031-2026-10-14", "retrieved_at": "2026-10-14T18:21:08Z", "content_hash": "49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p140031", "source_type": "regulator", "title": "FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P140031&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P140031", "normalized_value": "P140031", "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 P140031 (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-P140031.json. The record gives the applicant's street address; records here do not repeat it. 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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": "ed030f9b9c6b82a5011696d340b122aa909385508c57c6cb08f96a8b7d83e822", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-fda-p140031-approval.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fda-p140031-s085-low-risk", "owner": "cardio", "subject_entity_id": "cardio:sapien-3", "category": "regulatory", "statement": "On 2019-08-16 the US Food and Drug Administration approved PMA supplement S085 to P140031, applicant Edwards Lifesciences, LLC, for the Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems. The supplement widens the use of these valves 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. The openFDA record lists the supplement type as Panel Track and the reason as a labeling change to the indications, instructions, shelf life or trade name.", "context": { "id": "cardio:ctx-fda-p140031-s085-low-risk-severe-as", "label": "United States PMA supplement P140031 S085: SAPIEN 3 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. 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. 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