# SAPIEN 3 transcatheter heart valve

Product · id `cardio:sapien-3` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Also called: Edwards SAPIEN 3; SAPIEN 3 Ultra; SAPIEN 3 THV

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

## In plain language

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.

## Technical summary

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.

## Claims, with the population each applies to

## Context: United States PMA approval P140031: SAPIEN 3 for severe aortic stenosis at high or greater 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 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: Not stated in the FDA record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)

### 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.

- 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 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: 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 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).
- Last checked: 2026-10-14
- Sources:
  1. Supports: FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140031&sort=decision_date:asc&limit=1>
     Locator: results\[0\].pma\_number. Retrieved 2026-10-14T18:21:08Z. Source state: Current. Snapshot hash: 49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90.
     How it applies: The PMA number of this record.
  2. Supports: FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140031&sort=decision_date:asc&limit=1>
     Locator: results\[0\].applicant. Retrieved 2026-10-14T18:21:08Z. Source state: Current. Snapshot hash: 49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90.
     How it applies: The applicant, as FDA writes the name.
  3. Supports: FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140031&sort=decision_date:asc&limit=1>
     Locator: results\[0\].trade\_name. Retrieved 2026-10-14T18:21:08Z. Source state: Current. Snapshot hash: 49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90.
     How it applies: The trade name FDA gives this record.
  4. Supports: FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140031&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:21:08Z. Source state: Current. Snapshot hash: 49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90.
     How it applies: ISO date of the decision.
  5. Supports: FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140031&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-14T18:21:08Z. Source state: Current. Snapshot hash: 49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90.
     How it applies: FDA decision code: APPR is an approval.
  6. Supports: FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140031&sort=decision_date:asc&limit=1>
     Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:21:08Z. Source state: Current. Snapshot hash: 49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90.
     How it applies: FDA product code of this record.
  7. Supports: FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140031&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement. Retrieved 2026-10-14T18:21:08Z. Source state: Current. Snapshot hash: 49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90.
     How it applies: FDA approval order statement: the approved indication, quoted in fragments.
  8. Background: FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P140031&sort=decision_date:asc&limit=1>
     Locator: meta.disclaimer. Retrieved 2026-10-14T18:21:08Z. Source state: Current. Snapshot hash: 49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90.
     How it applies: openFDA's own disclaimer about relying on its data.
  9. Supports: FDA summary of safety and effectiveness data for PMA P140031 (SAPIEN 3) (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/pdf14/P140031B.pdf>
     Locator: Section II, Indications for use. Retrieved 2026-10-14T19:20:15Z. Source state: Current. Snapshot hash: 86e0727ff92121d593272b44d17318e6df64030b4c9e72263360c33d20249fb1.
     How it applies: The summary of safety and effectiveness prints the risk thresholds with their comparison symbols, which openFDA drops.

## Context: United States PMA supplement P140031 S085: SAPIEN 3 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 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.

- 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 PARTNER 3.
- Last checked: 2026-10-14
- Sources:
  1. Supports: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, 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:P140031+AND+supplement_number:S085&limit=1>
     Locator: results\[0\].pma\_number. Retrieved 2026-10-14T18:21:14Z. Source state: Current. Snapshot hash: eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537.
     How it applies: The PMA number of this record.
  2. Supports: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, 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:P140031+AND+supplement_number:S085&limit=1>
     Locator: results\[0\].supplement\_number. Retrieved 2026-10-14T18:21:14Z. Source state: Current. Snapshot hash: eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537.
     How it applies: The supplement number of this record.
  3. Supports: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, 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:P140031+AND+supplement_number:S085&limit=1>
     Locator: results\[0\].applicant. Retrieved 2026-10-14T18:21:14Z. Source state: Current. Snapshot hash: eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537.
     How it applies: The applicant, as FDA writes the name.
  4. Supports: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, 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:P140031+AND+supplement_number:S085&limit=1>
     Locator: results\[0\].trade\_name. Retrieved 2026-10-14T18:21:14Z. Source state: Current. Snapshot hash: eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537.
     How it applies: The trade name FDA gives this record.
  5. Supports: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, 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:P140031+AND+supplement_number:S085&limit=1>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:21:14Z. Source state: Current. Snapshot hash: eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537.
     How it applies: ISO date of the decision.
  6. Supports: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, 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:P140031+AND+supplement_number:S085&limit=1>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-14T18:21:14Z. Source state: Current. Snapshot hash: eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537.
     How it applies: FDA decision code: APPR is an approval.
  7. Supports: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, 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:P140031+AND+supplement_number:S085&limit=1>
     Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:21:14Z. Source state: Current. Snapshot hash: eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537.
     How it applies: FDA product code of this record.
  8. Supports: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, 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:P140031+AND+supplement_number:S085&limit=1>
     Locator: results\[0\].ao\_statement. Retrieved 2026-10-14T18:21:14Z. Source state: Current. Snapshot hash: eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537.
     How it applies: FDA approval order statement: the approved indication, quoted in fragments.
  9. Background: FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record) (Regulator, edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, 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:P140031+AND+supplement_number:S085&limit=1>
     Locator: meta.disclaimer. Retrieved 2026-10-14T18:21:14Z. Source state: Current. Snapshot hash: eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537.
     How it applies: openFDA's own disclaimer about relying on its data.
  10. Supports: FDA approval order for PMA supplement P140031/S085 (SAPIEN 3 and SAPIEN 3 Ultra, 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/pdf14/P140031S085A.pdf>
     Locator: page 1, Re: line. Retrieved 2026-10-14T19:20:09Z. Source state: Current. Snapshot hash: fb07accd6aed264d9a2ddd878453dc574ad73aece638424c9f108c35bb39a464.
     How it applies: The FDA approval order names the supplement as P140031/S085.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-p140031-s085`

- Product: SAPIEN 3 transcatheter heart valve (`cardio:sapien-3`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Supplemental approval, 2019-08-16
- Product version: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems (PMA supplement S085)
- Pathway: PMA
- Submission: P140031/S085
- Product code: NPT
- Device class: III
- Indication: PMA supplement S085 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.
- 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-p140031-s085-low-risk`

### Regulatory decision `cardio:regdec-fda-p140031`

- Product: SAPIEN 3 transcatheter heart valve (`cardio:sapien-3`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2015-06-17
- Product version: Edwards SAPIEN 3 transcatheter heart valve, model 9600TFX, and accessories (original approval)
- Pathway: PMA
- Submission: P140031
- Product code: NPT
- Device class: III
- Indication: 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 to be at high or greater risk 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 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: 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-p140031-approval`

## Connected pages

- Applicant on P140031 is Edwards Lifesciences, LLC; the sources read do not say who makes the valve: Edwards Lifesciences (`cardio:edwards-lifesciences`)
- 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: EARLY TAVR (`cardio:early-tavr`)
- Investigated in: PARTNER 3 trial (`cardio:partner-3`)

## Provenance

Content hash: 91727267cc48895bb12ceb9dd406729efdd88d136fd502c5363d182df44b80b6
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14