Cardiovascular Atlas
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MitraClip

A device from Abbott for leaky mitral valves. It is delivered through a catheter and is a form of transcatheter edge-to-edge repair. The US FDA approved it in 2013 for people with a degenerative leak who are at prohibitive risk for surgery, and in 2019 added people with a moderate-to-severe or severe leak caused by heart muscle weakness (secondary mitral regurgitation), a left ventricular ejection fraction from 20% to 50%, both included, and an end-systolic dimension of the left ventricle of 70 mm or less, whose symptoms continue despite the fullest guideline-directed medical therapy they tolerate, as judged by a heart team. The COAPT trial tested it in that second group.

Also called MitraClip NT · MitraClip NTR/XTR · MitraClip System

  • Product
  • In this atlas

Overview

Technical summary

MitraClip Clip Delivery System, FDA product code NKM. PMA P100009 original approval 2013-10-24 (degenerative mitral regurgitation, prohibitive surgical risk); supplement S028, 2019-03-14, for the MitraClip NT and NTR/XTR Clip Delivery Systems, adds symptomatic moderate-to-severe or severe secondary mitral regurgitation in people who also take the fullest guideline-directed medical therapy they tolerate. COAPT registry NCT01626079 names the intervention MitraClip System. Later systems under the same PMA number are not read here.

Product details

Type
Device
Model or formulation
MitraClip Clip Delivery System; MitraClip NT and NTR/XTR Clip Delivery Systems
Version
The original approval names the MitraClip Clip Delivery System. The 2019 supplement names the NT and NTR/XTR systems. Later systems under the same PMA number are not read here.

Intended-use sources

  1. Background FDA premarket approval record P100009: MitraClip Clip Delivery 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 P100009 (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: P100009

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771
    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-P100009.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. Background FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
    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-P100009-S028.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 heart failure and moderate-to-severe or severe secondary mitral regurgitation, randomized in COAPT

Recipient
Adult
Population
Patients 18 years or older (registry minimum age) with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy; 614 were randomized (302 to the device group and 312 to the control group). The registry record also covers a continued access study of 162 further patients. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
Care setting
78 sites in the United States and Canada (abstract)
Geography
United States and Canada
Life stage
Registry minimum age 18 years; no maximum age
Follow-up
The primary effectiveness end point covers 24 months; the primary safety end point is at 12 months (abstract). The registry gives the primary completion as 2019-03 and an estimated study completion of 2024-07, with a recruitment status of unknown.
Eligibility: 3 inclusion criteria; exclusion criteria not stated
Included
  • Heart failure with moderate-to-severe or severe secondary mitral regurgitation
  • Symptoms despite maximal doses of guideline-directed medical therapy
  • Age 18 years or older (registry)
Excluded
None stated

  • Effect Interventional Certainty not assessed

    In COAPT, death from any cause within 24 months occurred in 29.1% of the patients in the MitraClip plus medicines group and in 46.1% of the patients in the medicines alone group (hazard ratio 0.62, 95% confidence interval 0.46 to 0.82).

    Applies to Adult
    • Patients 18 years or older (registry minimum age) with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy; 614 were randomized (302 to the device group and 312 to the control group). The registry record also covers a continued access study of 162 further patients. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
    • 78 sites in the United States and Canada (abstract)
    • United States and Canada
    • Registry minimum age 18 years; no maximum age
    Follow-up The primary effectiveness end point covers 24 months; the primary safety end point is at 12 months (abstract). The registry gives the primary completion as 2019-03 and an estimated study completion of 2024-07, with a recruitment status of unknown.
    Certainty method
    Not assessed
    Limitations
    The abstract does not name death from any cause among the end points in its methods; it reports 24-month death as a result. The registry lists all-cause mortality among its secondary outcomes (a count at 12 months, and Kaplan-Meier freedom from all-cause mortality at 24 months). The abstract does not say whether this test was prespecified or adjusted for multiple comparisons, so treat it as a secondary result. The same limits apply as for the heart-failure hospitalization claim: funded by Abbott, no masking in the registry, selected patients with secondary mitral regurgitation on maximal medicines. Only the abstract was read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (4)

    1. Supports Transcatheter Mitral-Valve Repair in Patients with Heart Failure

      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 2018-12-13 · DOI: 10.1056/NEJMoa1806640 · PMID: 30280640

      Locator
      Abstract, RESULTS, sentence 4
      How it applies
      Death from any cause by group, and the hazard ratio.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49
      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. Supports Transcatheter Mitral-Valve Repair in Patients with Heart Failure

      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 2018-12-13 · DOI: 10.1056/NEJMoa1806640 · PMID: 30280640

      Locator
      Abstract, CONCLUSIONS, sentence 1
      How it applies
      The authors report lower all-cause mortality within 24 months.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49
      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. Background Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2023-11-27. · NCT: NCT01626079

      Locator
      protocolSection.outcomesModule.secondaryOutcomes[24].measure
      How it applies
      The registry lists all-cause mortality at 12 months among its secondary outcomes.
      Retrieved
      Source effective date
      2023-11-27
      Source state
      Current
      Snapshot hash
      c704470d9e281e9b6ab5a19cc4735faa44c97e48e3d57e3fbc41ed6c84710da1
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT01626079.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.

    4. Background Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2023-11-27. · NCT: NCT01626079

      Locator
      protocolSection.outcomesModule.secondaryOutcomes[48].measure
      How it applies
      The registry also lists Kaplan-Meier freedom from all-cause mortality as a secondary outcome.
      Retrieved
      Source effective date
      2023-11-27
      Source state
      Current
      Snapshot hash
      c704470d9e281e9b6ab5a19cc4735faa44c97e48e3d57e3fbc41ed6c84710da1
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT01626079.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.

  • Effect Interventional Certainty not assessed

    In COAPT, 614 patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who were still symptomatic on maximal medicines were randomized at 78 sites in the United States and Canada to the MitraClip device plus medicines (302 patients) or medicines alone (312 patients). The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year with the device and 67.9% per patient-year with medicines alone (hazard ratio 0.53, 95% confidence interval 0.40 to 0.70). The primary safety end point, freedom from device-related complications at 12 months, was 96.6% (lower 95% confidence limit 94.8%), above the prespecified goal of 88.0%.

    Applies to Adult
    • Patients 18 years or older (registry minimum age) with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy; 614 were randomized (302 to the device group and 312 to the control group). The registry record also covers a continued access study of 162 further patients. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
    • 78 sites in the United States and Canada (abstract)
    • United States and Canada
    • Registry minimum age 18 years; no maximum age
    Follow-up The primary effectiveness end point covers 24 months; the primary safety end point is at 12 months (abstract). The registry gives the primary completion as 2019-03 and an estimated study completion of 2024-07, with a recruitment status of unknown.
    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 lists no masking. The result applies to the group enrolled: symptomatic heart failure with secondary mitral regurgitation despite maximal medicines. It does not show the same effect in people with primary (degenerative) mitral regurgitation or in people who are not on maximal medicines. Other trials of the same device in similar patients are not covered in this record. The registry shows a recruitment status of unknown with an estimated completion in 2024-07, which is out of date. Only the abstract was read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (5)

    1. Supports Transcatheter Mitral-Valve Repair in Patients with Heart Failure

      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 2018-12-13 · DOI: 10.1056/NEJMoa1806640 · PMID: 30280640

      Locator
      Abstract, RESULTS, sentence 2
      How it applies
      Annualized rate of heart-failure hospitalization by group, and the hazard ratio.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49
      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. Supports Transcatheter Mitral-Valve Repair in Patients with Heart Failure

      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 2018-12-13 · DOI: 10.1056/NEJMoa1806640 · PMID: 30280640

      Locator
      Abstract, RESULTS, sentence 3
      How it applies
      Primary safety end point.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49
      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 Mitral-Valve Repair in Patients with Heart Failure

      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 2018-12-13 · DOI: 10.1056/NEJMoa1806640 · PMID: 30280640

      Locator
      Abstract, CONCLUSIONS, sentences 1 and 2
      How it applies
      The authors' conclusion for the same population.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49
      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 Mitral-Valve Repair in Patients with Heart Failure

      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 2018-12-13 · DOI: 10.1056/NEJMoa1806640 · PMID: 30280640

      Locator
      Abstract, METHODS, sentences 1 to 4
      How it applies
      Design, sites, population and end points.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49
      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 Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2023-11-27. · NCT: NCT01626079

      Locator
      protocolSection.designModule.designInfo.maskingInfo.masking
      How it applies
      The registry records no masking.
      Retrieved
      Source effective date
      2023-11-27
      Source state
      Current
      Snapshot hash
      c704470d9e281e9b6ab5a19cc4735faa44c97e48e3d57e3fbc41ed6c84710da1
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT01626079.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 P100009: MitraClip for degenerative mitral regurgitation at prohibitive surgical risk

Recipient
Recipient not specified
Population
Patients with significant symptomatic mitral regurgitation (MR of grade 3+ or more) due to a primary abnormality of the mitral apparatus (degenerative MR) whom a heart team, including a cardiac surgeon and a cardiologist experienced in mitral valve disease, judges to be at prohibitive risk for mitral valve surgery, and in whom existing comorbidities would not preclude the expected benefit. 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)
Eligibility: 3 inclusion criteria; exclusion criteria not stated
Included
  • Significant symptomatic mitral regurgitation (3+ or more) due to a primary abnormality of the mitral apparatus (degenerative MR)
  • Judged by a heart team to be at prohibitive risk for mitral valve surgery
  • Existing comorbidities would not preclude the expected benefit
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    On 2013-10-24 the US Food and Drug Administration approved the MitraClip Clip Delivery System under PMA P100009, product code NKM, applicant ABBOTT MEDICAL. The approval order states the use as percutaneous reduction of significant symptomatic mitral regurgitation (MR of 3+ or more) due to a primary abnormality of the mitral apparatus (degenerative MR) in patients determined by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, to be at prohibitive risk for mitral valve surgery, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

    Applies to Recipient not specified
    • Patients with significant symptomatic mitral regurgitation (MR of grade 3+ or more) due to a primary abnormality of the mitral apparatus (degenerative MR) whom a heart team, including a cardiac surgeon and a cardiologist experienced in mitral valve disease, judges to be at prohibitive risk for mitral valve surgery, and in whom existing comorbidities would not preclude the expected benefit. The order gives no age range.
    • Not stated in the FDA record beyond the heart team judgement
    • 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. This original approval covers degenerative mitral regurgitation only. Secondary mitral regurgitation, the group studied in COAPT, was added by supplement S028, which has its own record.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (8)

    1. Supports FDA premarket approval record P100009: MitraClip Clip Delivery 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 P100009 (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: P100009

      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
      b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771
      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-P100009.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 P100009: MitraClip Clip Delivery 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 P100009 (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: P100009

      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
      b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771
      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-P100009.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 P100009: MitraClip Clip Delivery 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 P100009 (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: P100009

      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
      b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771
      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-P100009.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 P100009: MitraClip Clip Delivery 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 P100009 (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: P100009

      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
      b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771
      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-P100009.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 P100009: MitraClip Clip Delivery 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 P100009 (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: P100009

      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
      b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771
      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-P100009.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 P100009: MitraClip Clip Delivery 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 P100009 (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: P100009

      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
      b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771
      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-P100009.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 P100009: MitraClip Clip Delivery 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 P100009 (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: P100009

      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
      b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771
      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-P100009.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 P100009: MitraClip Clip Delivery 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 P100009 (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: P100009

      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
      b612cc47f918e49f5972cf9c4d336e014df2ee0ec6f946011d77e91bcb0a9771
      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-P100009.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.

Context United States PMA supplement P100009 S028: MitraClip for secondary mitral regurgitation

Recipient
Recipient not specified
Population
People with symptomatic secondary (functional) mitral regurgitation graded moderate-to-severe or severe (grade III or more by American Society of Echocardiography criteria), a left ventricular ejection fraction from 20% to 50%, both included, and an end-systolic dimension of the left ventricle of 70 mm or less, whose symptoms and regurgitation continue despite the fullest guideline-directed medical therapy the person tolerates, as judged by a multidisciplinary team of heart specialists with experience in heart failure and mitral valve disease. The order gives no age range.
Care setting
A heart team drawn from several specialties, with experience in heart failure and mitral valve disease, makes the call (the order's requirement, paraphrased)
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: 4 inclusion criteria; exclusion criteria not stated
Included
  • Symptomatic moderate-to-severe or severe secondary mitral regurgitation (grade III or more)
  • Left ventricular ejection fraction from 20% to 50%, both included
  • End-systolic dimension of the left ventricle of 70 mm or less
  • Symptoms and regurgitation continue despite the fullest guideline-directed medical therapy the person tolerates
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    On 2019-03-14 the US Food and Drug Administration approved PMA supplement S028 to P100009, applicant ABBOTT MEDICAL. The supplement covers the MitraClip NT Clip Delivery System together with the MitraClip NTR/XTR Clip Delivery System, and it adds secondary mitral regurgitation to the uses. The approved use is to be used together with the fullest guideline-directed medical therapy the person tolerates, in people who have symptoms from secondary (functional) mitral regurgitation graded moderate-to-severe or severe, a left ventricular ejection fraction from 20% to 50%, both included, and an end-systolic dimension of the left ventricle of 70 mm or less, and whose symptoms and regurgitation remain despite that therapy, as judged by a multidisciplinary heart team.

    Applies to Recipient not specified
    • People with symptomatic secondary (functional) mitral regurgitation graded moderate-to-severe or severe (grade III or more by American Society of Echocardiography criteria), a left ventricular ejection fraction from 20% to 50%, both included, and an end-systolic dimension of the left ventricle of 70 mm or less, whose symptoms and regurgitation continue despite the fullest guideline-directed medical therapy the person tolerates, as judged by a multidisciplinary team of heart specialists with experience in heart failure and mitral valve disease. The order gives no age range.
    • A heart team drawn from several specialties, with experience in heart failure and mitral valve disease, makes the call (the order's requirement, paraphrased)
    • 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 openFDA record does not name the trial behind the supplement, so this record does not link the supplement to COAPT.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (10)

    1. Supports FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
      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-P100009-S028.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 P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].supplement_number
      How it applies
      The supplement number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
      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-P100009-S028.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 P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
      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-P100009-S028.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 P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
      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-P100009-S028.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 P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
      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-P100009-S028.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 P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
      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-P100009-S028.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 P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
      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-P100009-S028.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. Supports FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
      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-P100009-S028.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.

    9. Background FDA premarket approval record P100009/S028: MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028, secondary mitral regurgitation) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P100009 supplement S028, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      13c9e14b86d0945ee657a351da9eed24010332b52b00125175f76bfe83fb5ef0
      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-P100009-S028.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.

    10. Supports FDA approval order for PMA supplement P100009/S028 (MitraClip, secondary mitral regurgitation)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database. · PMA: P100009/S028

      Locator
      page 1, Re: line
      How it applies
      The FDA approval order names the supplement as P100009/S028.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      9f32bc5b9932239acb871ef7ca9ae9513c7b8608f4df8d8ffa0d36dafdc795f8
      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.

Authorization

Regulatory decision: MitraClip

Applies to Recipient not specified
  • People with symptomatic secondary (functional) mitral regurgitation graded moderate-to-severe or severe (grade III or more by American Society of Echocardiography criteria), a left ventricular ejection fraction from 20% to 50%, both included, and an end-systolic dimension of the left ventricle of 70 mm or less, whose symptoms and regurgitation continue despite the fullest guideline-directed medical therapy the person tolerates, as judged by a multidisciplinary team of heart specialists with experience in heart failure and mitral valve disease. The order gives no age range.
  • A heart team drawn from several specialties, with experience in heart failure and mitral valve disease, makes the call (the order's requirement, paraphrased)
  • 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
Supplemental approval,
Pathway
PMA
Submission
P100009/S028
Product code
NKM
Device class
Class III
Jurisdictions
United States; note: United States
Product version
MitraClip NT and NTR/XTR Clip Delivery Systems (PMA supplement S028)
Indication
PMA supplement S028 expands the indication to include symptomatic moderate-to-severe or severe secondary (functional) mitral regurgitation (grade III or more) in patients with a left ventricular ejection fraction of 20% to 50% and a left ventricular end systolic dimension of 70 mm or less, whose symptoms and mitral regurgitation persist despite maximally tolerated guideline-directed medical therapy, as determined by a multidisciplinary heart team experienced in heart failure and mitral valve disease.
Basis
On 2019-03-14 the US Food and Drug Administration approved PMA supplement S028 to P100009, applicant ABBOTT MEDICAL. The supplement covers the MitraClip NT Clip Delivery System together with the MitraClip NTR/XTR Clip Delivery System, and it adds secondary mitral regurgitation to the uses. The approved use is to be used together with the fullest guideline-directed medical therapy the person tolerates, in people who have symptoms from secondary (functional) mitral regurgitation graded moderate-to-severe or severe, a left ventricular ejection fraction from 20% to 50%, both included, and an end-systolic dimension of the left ventricle of 70 mm or less, and whose symptoms and regurgitation remain despite that therapy, as judged 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 openFDA record does not name the trial behind the supplement, so this record does not link the supplement to COAPT.

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

Regulatory decision: MitraClip

Applies to Recipient not specified
  • Patients with significant symptomatic mitral regurgitation (MR of grade 3+ or more) due to a primary abnormality of the mitral apparatus (degenerative MR) whom a heart team, including a cardiac surgeon and a cardiologist experienced in mitral valve disease, judges to be at prohibitive risk for mitral valve surgery, and in whom existing comorbidities would not preclude the expected benefit. The order gives no age range.
  • Not stated in the FDA record beyond the heart team judgement
  • 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
P100009
Product code
NKM
Device class
Class III
Jurisdictions
United States; note: United States
Product version
MitraClip Clip Delivery System (original approval)
Indication
Percutaneous reduction of significant symptomatic degenerative mitral regurgitation (MR of 3+ or more) in patients a heart team judges to be at prohibitive risk for mitral valve surgery, and in whom existing comorbidities would not preclude the expected benefit.
Basis
On 2013-10-24 the US Food and Drug Administration approved the MitraClip Clip Delivery System under PMA P100009, product code NKM, applicant ABBOTT MEDICAL. The approval order states the use as percutaneous reduction of significant symptomatic mitral regurgitation (MR of 3+ or more) due to a primary abnormality of the mitral apparatus (degenerative MR) in patients determined by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, to be at prohibitive risk for mitral valve surgery, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

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 degenerative mitral regurgitation only. Secondary mitral regurgitation, the group studied in COAPT, was added by supplement S028, which has its own record.

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:mitraclip
Content hash
7c31f1e3e0eaebce050eaa9d0612e0362e5318f3ad9dce0bd36855d040e18a61