# CoreValve and Evolut transcatheter valves

Product · id `cardio:corevalve-evolut` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Also called: Medtronic CoreValve; Evolut R; Evolut PRO; Evolut

Browse, organ or system: Heart  
Browse, condition area: Valve and congenital heart disease  

## In plain language

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.

## Technical summary

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.

## Claims, with the population each applies to

## Context: Patients with severe aortic stenosis at low surgical risk, randomized in the Evolut Low Risk trial

Recipient: Recipient not specified; 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: Mean age 74 years (abstract); the registry lists no age limits; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: 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.

### 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).

- Category: Safety
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Recipient not specified; 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: Mean age 74 years (abstract); the registry lists no age limits; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: 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.
- 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.
- Last checked: 2026-10-14
- Sources:
  1. Supports: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, 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.) <https://doi.org/10.1056/NEJMoa1816885>
     Locator: Abstract, RESULTS, sentence 4. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4.
     How it applies: 30-day outcomes in both directions.
  2. Supports: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, 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.) <https://doi.org/10.1056/NEJMoa1816885>
     Locator: Abstract, RESULTS, sentence 5. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4.
     How it applies: 12-month valve gradient and orifice area.

### 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.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Recipient not specified; 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: Mean age 74 years (abstract); the registry lists no age limits; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: 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.
- 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.
- Last checked: 2026-10-14
- Sources:
  1. Supports: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, 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.) <https://doi.org/10.1056/NEJMoa1816885>
     Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4.
     How it applies: 24-month rates of the primary end point, the difference, the credible interval and the probability of noninferiority.
  2. Supports: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, 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.) <https://doi.org/10.1056/NEJMoa1816885>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4.
     How it applies: The authors conclude noninferiority.
  3. Background: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, 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.) <https://doi.org/10.1056/NEJMoa1816885>
     Locator: Abstract, METHODS, sentences 1 and 2. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4.
     How it applies: Design, population and the Bayesian analysis of the 24-month end point.
  4. Background: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, 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.) <https://doi.org/10.1056/NEJMoa1816885>
     Locator: Abstract, RESULTS, sentences 1 and 2. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4.
     How it applies: Number randomized and mean age.
  5. Background: Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients (Registry, edition ClinicalTrials.gov API v2 record, last update posted 2026-05-07.) <https://clinicaltrials.gov/study/NCT02701283>
     Locator: protocolSection.designModule.designInfo.maskingInfo.masking. Retrieved 2026-10-14T18:18:26Z. Source state: Current. Snapshot hash: bd30fbe5fbcc66a1a6b6a87329c13591d0f40b947c57fbbe55d5aa866879c467.
     How it applies: The registry records no masking.

## Context: United States PMA approval P130021: CoreValve for severe aortic stenosis at extreme risk or inoperable

Recipient: Recipient not specified; 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: Not stated in the FDA record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: Recipient: Recipient not specified; 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: Not stated in the FDA record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- 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.
- Last checked: 2026-10-14
- Sources:
  1. Supports: FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021&sort=decision_date:asc&limit=1>
     Locator: results\[0\].pma\_number. Retrieved 2026-10-14T18:21:09Z. Source state: Current. Snapshot hash: 57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86.
     How it applies: The PMA number of this record.
  2. Supports: FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021&sort=decision_date:asc&limit=1>
     Locator: results\[0\].applicant. Retrieved 2026-10-14T18:21:09Z. Source state: Current. Snapshot hash: 57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86.
     How it applies: The applicant, as FDA writes the name.
  3. Supports: FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021&sort=decision_date:asc&limit=1>
     Locator: results\[0\].trade\_name. Retrieved 2026-10-14T18:21:09Z. Source state: Current. Snapshot hash: 57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86.
     How it applies: The trade name FDA gives this record.
  4. Supports: FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:21:09Z. Source state: Current. Snapshot hash: 57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86.
     How it applies: ISO date of the decision.
  5. Supports: FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-14T18:21:09Z. Source state: Current. Snapshot hash: 57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86.
     How it applies: FDA decision code: APPR is an approval.
  6. Supports: FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021&sort=decision_date:asc&limit=1>
     Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:21:09Z. Source state: Current. Snapshot hash: 57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86.
     How it applies: FDA product code of this record.
  7. Supports: FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement. Retrieved 2026-10-14T18:21:09Z. Source state: Current. Snapshot hash: 57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86.
     How it applies: FDA approval order statement: the approved indication, quoted in fragments.
  8. Background: FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021&sort=decision_date:asc&limit=1>
     Locator: meta.disclaimer. Retrieved 2026-10-14T18:21:09Z. Source state: Current. Snapshot hash: 57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86.
     How it applies: openFDA's own disclaimer about relying on its data.
  9. Supports: FDA summary of safety and effectiveness data for PMA P130021 (CoreValve) (Regulator, edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.) <https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130021B.pdf>
     Locator: Section II, Indications for use. Retrieved 2026-10-14T19:20:17Z. Source state: Current. Snapshot hash: 27c089e297885755028555129a7bc344e56278992a585790769c22fb7f8b9d66.
     How it applies: The summary of safety and effectiveness prints the area and risk thresholds with their comparison symbols, which openFDA drops.

## Context: United States PMA supplement P130021 S058: Evolut R and Evolut PRO for severe aortic stenosis at low surgical risk

Recipient: Recipient not specified; 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: Not stated in the FDA record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)

### On 2019-08-16 the US Food and Drug Administration approved PMA supplement S058 to P130021, applicant Medtronic, Inc. It covers the Medtronic CoreValve Evolut R System together with the Medtronic CoreValve Evolut PRO System. 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: Recipient: Recipient not specified; 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: Not stated in the FDA record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- 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 the Evolut Low Risk trial.
- Last checked: 2026-10-14
- Sources:
  1. Supports: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021+AND+supplement_number:S058&limit=1>
     Locator: results\[0\].pma\_number. Retrieved 2026-10-14T18:21:17Z. Source state: Current. Snapshot hash: 27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948.
     How it applies: The PMA number of this record.
  2. Supports: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021+AND+supplement_number:S058&limit=1>
     Locator: results\[0\].supplement\_number. Retrieved 2026-10-14T18:21:17Z. Source state: Current. Snapshot hash: 27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948.
     How it applies: The supplement number of this record.
  3. Supports: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021+AND+supplement_number:S058&limit=1>
     Locator: results\[0\].applicant. Retrieved 2026-10-14T18:21:17Z. Source state: Current. Snapshot hash: 27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948.
     How it applies: The applicant, as FDA writes the name.
  4. Supports: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021+AND+supplement_number:S058&limit=1>
     Locator: results\[0\].trade\_name. Retrieved 2026-10-14T18:21:17Z. Source state: Current. Snapshot hash: 27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948.
     How it applies: The trade name FDA gives this record.
  5. Supports: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021+AND+supplement_number:S058&limit=1>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:21:17Z. Source state: Current. Snapshot hash: 27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948.
     How it applies: ISO date of the decision.
  6. Supports: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021+AND+supplement_number:S058&limit=1>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-14T18:21:17Z. Source state: Current. Snapshot hash: 27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948.
     How it applies: FDA decision code: APPR is an approval.
  7. Supports: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021+AND+supplement_number:S058&limit=1>
     Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:21:17Z. Source state: Current. Snapshot hash: 27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948.
     How it applies: FDA product code of this record.
  8. Supports: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021+AND+supplement_number:S058&limit=1>
     Locator: results\[0\].ao\_statement. Retrieved 2026-10-14T18:21:17Z. Source state: Current. Snapshot hash: 27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948.
     How it applies: FDA approval order statement: the approved indication, quoted in fragments.
  9. Background: FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.) <https://api.fda.gov/device/pma.json?search=pma_number:P130021+AND+supplement_number:S058&limit=1>
     Locator: meta.disclaimer. Retrieved 2026-10-14T18:21:17Z. Source state: Current. Snapshot hash: 27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948.
     How it applies: openFDA's own disclaimer about relying on its data.
  10. Supports: FDA approval order for PMA supplement P130021/S058 (CoreValve Evolut R and Evolut PRO, low-risk indication) (Regulator, edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.) <https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130021S058A.pdf>
     Locator: page 1, Re: line. Retrieved 2026-10-14T19:20:10Z. Source state: Current. Snapshot hash: e0f375986b580ef4181c8cc7e828c37f74da0a9abdf93f83a762b93c5b677cb7.
     How it applies: The FDA approval order names the supplement as P130021/S058.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-p130021-s058`

- Product: CoreValve and Evolut transcatheter valves (`cardio:corevalve-evolut`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Supplemental approval, 2019-08-16
- Product version: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058)
- Pathway: PMA
- Submission: P130021/S058
- Product code: NPT
- Device class: III
- Indication: PMA supplement S058 expands the indication to include patients at low risk for surgical aortic valve replacement, for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis whom a heart team, including a cardiac surgeon, judges appropriate for transcatheter heart valve replacement therapy.
- Jurisdictions: United States; note: United States
- Applies to: Recipient: Recipient not specified; 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: Not stated in the FDA record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- Basis: claim `cardio:claim-fda-p130021-s058-low-risk`

### Regulatory decision `cardio:regdec-fda-p130021`

- Product: CoreValve and Evolut transcatheter valves (`cardio:corevalve-evolut`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2014-01-17
- Product version: Medtronic CoreValve System (original approval)
- Pathway: PMA
- Submission: P130021
- Product code: NPT
- Device class: III
- Indication: Relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis, with native aortic annulus diameters between 18 and 29 mm, whom a heart team, including a cardiac surgeon, judges to be at extreme risk or inoperable for open surgical therapy.
- Jurisdictions: United States; note: United States
- Applies to: Recipient: Recipient not specified; 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: Not stated in the FDA record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- Basis: claim `cardio:claim-fda-p130021-approval`

## Connected pages

- Applicant on P130021 is Medtronic, Inc.; the sources read do not say who makes the valve: Medtronic (`cardio:medtronic`)
- Device used for TAVR: Transcatheter aortic valve replacement (TAVR) (`cardio:tavr`)
- Filed under this front: Procedures and surgery (`cardio:front-procedures-and-surgery`)
- Investigated in: Evolut Low Risk trial (`cardio:evolut-low-risk`)

## Provenance

Content hash: c971d6622ca8ec79386df9f1dcaae6fbe7e52945af7feb88496d7c01e75a8f90
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14