{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:triclip", "owner": "cardio", "kind": "product", "slug": "triclip", "name": "TriClip", "aliases": [ "TriClip G4", "TriClip Device" ], "atlases": [ "cardio" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [], "navigation": { "cardio": { "system": [ "heart" ], "condition-area": [ "valvular-and-congenital-disease" ] } }, "payload": { "subtype": "device", "model_or_formulation": "TriClip G4 System (also named TriClip G4 Clip Delivery System in later supplements)", "version": "Later supplements to P230007 are not read here.", "intended_use_snapshots": [ "cardio:openfda-pma-p230007-2026-10-14" ] }, "content_digest": "b28f07dfdacba5f806cafdba45ad197ca78a74e5100d180ca1f32ed28c0d66c7", "review": { "content_digest": "b28f07dfdacba5f806cafdba45ad197ca78a74e5100d180ca1f32ed28c0d66c7", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fda-p230007-approval", "owner": "cardio", "subject_entity_id": "cardio:triclip", "category": "regulatory", "statement": "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.", "context": { "id": "cardio:ctx-fda-p230007-severe-tr-intermediate-risk", "label": "United States PMA approval P230007: TriClip G4 for severe tricuspid regurgitation", "recipient": "unknown", "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_note": "Not stated in the FDA record", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory decision)", "eligibility": { "inclusion": [ "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" ], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. The stated purpose is quality of life and functional status.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].pma_number", "applicability_note": "The PMA number of this record.", "snapshot": { "id": "cardio:openfda-pma-p230007-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p230007", "source_type": "regulator", "title": "FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P230007&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P230007", "normalized_value": "P230007", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for P230007 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. 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This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "meta.disclaimer", "applicability_note": "openFDA's own disclaimer about relying on its data.", "snapshot": { "id": "cardio:openfda-pma-p230007-2026-10-14", "retrieved_at": "2026-10-14T18:21:11Z", "content_hash": "d7355536c1d998032d89adf47081e9fd56d2ec3e93227d518567af13bbd5e071", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p230007", "source_type": "regulator", "title": "FDA premarket approval record P230007: TriClip G4 System (original PMA approval) (openFDA record)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P230007&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P230007", "normalized_value": "P230007", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA PMA record returned on 2026-10-14 for 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.", "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.", "public_text": "quote" } } ], "review": { "content_digest": "8abf6612a8a7355fbbf9b124f1f879de63fd8e301cb960d53cdc2a4e4ce49963", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-fda-p230007-approval.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-triluminate-primary", "owner": "cardio", "subject_entity_id": "cardio:triclip", "category": "effect", "statement": "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.", "context": { "id": "cardio:ctx-triluminate-severe-tr", "label": "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_note": "Registry minimum age 18 years; mean age 78 years (abstract)", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "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": { "inclusion": [ "Symptomatic severe tricuspid regurgitation", "Age 18 years or older (registry)" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 3", "applicability_note": "The primary end point result, as a win ratio.", "snapshot": { "id": "cardio:pubmed-36876753-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "4bcb9a0f855b7342a6e3a38e0b97f7d9b7cb3d693100165b1d95b2b5318dfc9e", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa2300525", "source_type": "publication", "title": "Transcatheter Repair for Patients with Tricuspid Regurgitation", "canonical_url": "https://doi.org/10.1056/NEJMoa2300525", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa2300525", "normalized_value": "10.1056/nejmoa2300525", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "36876753", "normalized_value": "36876753", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-05-18", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. 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