Cardiovascular Atlas
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TriClip

A device from Abbott for a leaky tricuspid valve (tricuspid regurgitation). It is delivered through a catheter and is a form of transcatheter edge-to-edge repair. The US FDA approved the TriClip G4 System in 2024 to improve quality of life and daily function in people with symptomatic severe tricuspid regurgitation who are at intermediate or greater risk for surgery. The TRILUMINATE trial tested it.

Also called TriClip G4 · TriClip Device

  • Product
  • In this atlas

Overview

Technical summary

TriClip G4 System, FDA product code NPS, PMA P230007, approved 2024-04-01. The FDA indication is improving quality of life and functional status, not survival or hospitalization. TRILUMINATE Pivotal registry NCT03904147 names the intervention TriClip Device. The atlas has no separate tricuspid regurgitation record, so the trial claim files under heart valve disease. Later supplements are not read here.

Product details

Type
Device
Model or formulation
TriClip G4 System (also named TriClip G4 Clip Delivery System in later supplements)
Version
Later supplements to P230007 are not read here.

Intended-use sources

  1. Background FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P230007 (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. · PMA: P230007

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071
    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-P230007.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

Claims and evidence

Context Adults with symptomatic severe tricuspid regurgitation, randomized in TRILUMINATE Pivotal

Recipient
Adult
Population
Patients 18 years or older (registry minimum age) with symptomatic severe tricuspid regurgitation, 350 of whom were randomized 1:1 at 65 centers in the United States, Canada and Europe (175 to each group). The abstract gives a mean age of 78 years, with 54.9% women. The registry record also covers a single-arm cohort and a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
Care setting
65 centers in the United States, Canada and Europe (abstract)
Geography
United States, Canada and Europe
Life stage
Registry minimum age 18 years; mean age 78 years (abstract)
Follow-up
The primary end point was at 12 months (abstract). The registry gives the primary completion as 2022-11-18 and an estimated study completion of 2029-04.
Eligibility: 2 inclusion criteria; exclusion criteria not stated
Included
  • Symptomatic severe tricuspid regurgitation
  • Age 18 years or older (registry)
Excluded
None stated

  • Effect Interventional Certainty not assessed

    In TRILUMINATE Pivotal, 350 patients with symptomatic severe tricuspid regurgitation were randomized 1:1 at 65 centers to transcatheter edge-to-edge repair (the TriClip device) plus medical therapy or to medical therapy alone (175 patients in each group). The primary end point was a hierarchical composite of death from any cause or tricuspid-valve surgery, hospitalization for heart failure, and an improvement of at least 15 points on the Kansas City Cardiomyopathy Questionnaire (a quality-of-life score) at 1 year. The result favored repair (win ratio 1.48, 95% confidence interval 1.06 to 2.13, P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The quality-of-life score changed by 12.3 points with repair and 0.6 points in the control group. At 30 days, 87.0% of the repair group and 4.8% of the control group had tricuspid regurgitation of no greater than moderate severity. 98.3% of the patients who had the procedure were free from major adverse events at 30 days.

    Applies to Adult
    • Patients 18 years or older (registry minimum age) with symptomatic severe tricuspid regurgitation, 350 of whom were randomized 1:1 at 65 centers in the United States, Canada and Europe (175 to each group). The abstract gives a mean age of 78 years, with 54.9% women. The registry record also covers a single-arm cohort and a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
    • 65 centers in the United States, Canada and Europe (abstract)
    • United States, Canada and Europe
    • Registry minimum age 18 years; mean age 78 years (abstract)
    Follow-up The primary end point was at 12 months (abstract). The registry gives the primary completion as 2022-11-18 and an estimated study completion of 2029-04.
    Certainty method
    Not assessed
    Limitations
    Funded by Abbott; the registry lists Abbott Medical Devices as lead sponsor and FDA lists ABBOTT MEDICAL as applicant for the device. The registry records masking of the outcomes assessor only. The abstract reports no apparent difference in death or tricuspid-valve surgery, or in hospitalization for heart failure, so the benefit shown is in the combined score, in quality of life and in the severity of the regurgitation. The abstract does not say how much each component contributed to the win ratio. The FDA indication is for quality of life and function, not for survival or hospitalization. The result is at 1 year. Only the abstract was read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (7)

    1. Supports Transcatheter Repair for Patients with Tricuspid Regurgitation

      Publication · 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. · Published 2023-05-18 · DOI: 10.1056/NEJMoa2300525 · PMID: 36876753

      Locator
      Abstract, RESULTS, sentence 3
      How it applies
      The primary end point result, as a win ratio.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      4bcb9a0f855b7342a6e3a38e0b97f7d9b7cb3d693100165b1d95b2b5318dfc9e
      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.

    2. Opposes Transcatheter Repair for Patients with Tricuspid Regurgitation

      Publication · 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. · Published 2023-05-18 · DOI: 10.1056/NEJMoa2300525 · PMID: 36876753

      Locator
      Abstract, RESULTS, sentence 4
      How it applies
      Death or tricuspid-valve surgery and heart-failure hospitalization did not appear to differ.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      4bcb9a0f855b7342a6e3a38e0b97f7d9b7cb3d693100165b1d95b2b5318dfc9e
      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.

    3. Supports Transcatheter Repair for Patients with Tricuspid Regurgitation

      Publication · 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. · Published 2023-05-18 · DOI: 10.1056/NEJMoa2300525 · PMID: 36876753

      Locator
      Abstract, RESULTS, sentences 5 to 7
      How it applies
      Quality-of-life change, regurgitation at 30 days and 30-day safety.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      4bcb9a0f855b7342a6e3a38e0b97f7d9b7cb3d693100165b1d95b2b5318dfc9e
      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.

    4. Background Transcatheter Repair for Patients with Tricuspid Regurgitation

      Publication · 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. · Published 2023-05-18 · DOI: 10.1056/NEJMoa2300525 · PMID: 36876753

      Locator
      Abstract, METHODS, sentences 1 to 3
      How it applies
      Design, sites and the definition of the primary end point.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      4bcb9a0f855b7342a6e3a38e0b97f7d9b7cb3d693100165b1d95b2b5318dfc9e
      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.

    5. Background TRILUMINATE Pivotal Trial

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-12-19. · NCT: NCT03904147

      Locator
      protocolSection.designModule.designInfo.maskingInfo.whoMasked[0]
      How it applies
      The registry records the outcomes assessor as the one masked party.
      Retrieved
      Source effective date
      2024-12-19
      Source state
      Current
      Snapshot hash
      eaffdf5982436716f80e451c85f426687ddb1535fd6ddd11c41dd6677f9c7255
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT03904147.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.

    6. Background TRILUMINATE Pivotal Trial

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-12-19. · NCT: NCT03904147

      Locator
      protocolSection.armsInterventionsModule.armGroups[0].description
      How it applies
      Registry description of the device group: TriClip implantation with continued medical therapy.
      Retrieved
      Source effective date
      2024-12-19
      Source state
      Current
      Snapshot hash
      eaffdf5982436716f80e451c85f426687ddb1535fd6ddd11c41dd6677f9c7255
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT03904147.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.

    7. Background TRILUMINATE Pivotal Trial

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-12-19. · NCT: NCT03904147

      Locator
      protocolSection.armsInterventionsModule.armGroups[1].description
      How it applies
      Registry description of the control group: continued medical therapy.
      Retrieved
      Source effective date
      2024-12-19
      Source state
      Current
      Snapshot hash
      eaffdf5982436716f80e451c85f426687ddb1535fd6ddd11c41dd6677f9c7255
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT03904147.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.

Context United States PMA approval P230007: TriClip G4 for severe tricuspid regurgitation

Recipient
Recipient not specified
Population
Patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, at intermediate or greater risk for surgery, in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team. The order gives no age range.
Care setting
Multidisciplinary heart team (order wording)
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)
Eligibility: 3 inclusion criteria; exclusion criteria not stated
Included
  • Symptomatic severe tricuspid regurgitation despite optimal medical therapy
  • Intermediate or greater risk for surgery
  • Transcatheter edge-to-edge repair clinically appropriate and expected to reduce regurgitation to moderate or less
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    On 2024-04-01 the US Food and Drug Administration approved the TriClip G4 System under PMA P230007, product code NPS, applicant ABBOTT MEDICAL. The approval order states the use as improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.

    Applies to Recipient not specified
    • Patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, at intermediate or greater risk for surgery, in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team. The order gives no age range.
    • Multidisciplinary heart team (order wording)
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA record
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    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 stated purpose is quality of life and functional status.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (8)

    1. Supports FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P230007 (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. · PMA: P230007

      Locator
      results[0].pma_number
      How it applies
      The PMA number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071
      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-P230007.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    2. Supports FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P230007 (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. · PMA: P230007

      Locator
      results[0].applicant
      How it applies
      The applicant, as FDA writes the name.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071
      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-P230007.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    3. Supports FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P230007 (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. · PMA: P230007

      Locator
      results[0].trade_name
      How it applies
      The trade name FDA gives this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071
      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-P230007.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    4. Supports FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P230007 (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. · PMA: P230007

      Locator
      results[0].decision_date
      How it applies
      ISO date of the decision.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071
      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-P230007.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    5. Supports FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P230007 (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. · PMA: P230007

      Locator
      results[0].decision_code
      How it applies
      FDA decision code: APPR is an approval.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071
      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-P230007.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    6. Supports FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P230007 (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. · PMA: P230007

      Locator
      results[0].product_code
      How it applies
      FDA product code of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071
      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-P230007.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    7. Supports FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P230007 (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. · PMA: P230007

      Locator
      results[0].ao_statement
      How it applies
      FDA approval order statement: the approved indication, quoted in fragments.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071
      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-P230007.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    8. Background FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P230007 (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. · PMA: P230007

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071
      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-P230007.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

Authorization

Regulatory decision: TriClip

Applies to Recipient not specified
  • Patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, at intermediate or greater risk for surgery, in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team. The order gives no age range.
  • Multidisciplinary heart team (order wording)
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA record
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
PMA
Submission
P230007
Product code
NPS
Device class
Class III
Jurisdictions
United States; note: United States
Product version
TriClip G4 System (original approval)
Indication
Improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, at intermediate or greater risk for surgery, in whom transcatheter edge-to-edge repair is clinically appropriate and expected to reduce regurgitation severity to moderate or less.
Basis
On 2024-04-01 the US Food and Drug Administration approved the TriClip G4 System under PMA P230007, product code NPS, applicant ABBOTT MEDICAL. The approval order states the use as improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.

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 stated purpose is quality of life and functional status.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Record details

Record id
cardio:triclip
Content hash
b28f07dfdacba5f806cafdba45ad197ca78a74e5100d180ca1f32ed28c0d66c7