Organization (Industry)
EDWARDS LIFESCIENCES LLC
ClinicalTrials.gov lists EDWARDS LIFESCIENCES LLC as lead sponsor of 128 trials. It has 4 active development programs.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 9 registered with a 2026 start date. The hollow diamonds on the dashed line are a forecast of the full-year count, planned starts included: about 8 in 2026 and about 7 in 2027, the average of the 24 months through September, counted as registered and carried forward. The columns, the lighter one included, count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. This method has not been backtested on organizations. In backtests on conditions with as many trial starts a year as this organization (5 to 20), forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored. The 2026 forecast is below the 9 already registered with a 2026 start date: at the cutoff, 3 trials were already registered to start in October to December, more than the method's monthly average allows for, and the method does not use those planned starts. 2 trials are registered to start in 2027 or later.
Logo Kopiersperre ( talk ), via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.
This page covers EDWARDS LIFESCIENCES LLC: 128 lead-sponsored trials and 8 legal-entity registrations.
Disease areas (59)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Aortic Valve Stenosis | 66 |
| Mitral Valve Insufficiency | 36 |
| Tricuspid Valve Insufficiency | 18 |
| Heart Failure | 15 |
| Deglutition Disorders | 9 |
Showing 5 of 59 disease areas.
Trials by start year as sponsor or collaborator (21)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 2 trials are registered to start in 2027 or later, and not listed here.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 9 |
| 2025 | 6 |
| 2024 | 9 |
| 2023 | 12 |
| 2022 | 9 |
| 2021 | 17 |
| 2020 | 13 |
| 2019 | 13 |
| 2018 | 16 |
| 2017 | 17 |
Showing 10 of 21 years.
Prediction, not a registry value: median of 13 months from start to primary completion across 10 trials still running at the 2026-10-09 snapshot; registered median of 26 months across 92 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (4)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Optimal Medical Therapy | Tricuspid Valve Insufficiency | Not reported | 2 |
| Sham Procedure | Heart Failure | Not reported | 1 |
| Optimal Medical Therapy | Heart Failure | Not reported | 1 |
| Guideline Directed Medical Therapy | Mitral Valve Insufficiency | Not reported | 1 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 51% hit target (n=57) | 38% on time (n=55) |
Journals published in (124)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Journal of the American College of Cardiology | 35 |
| JACC. Cardiovascular interventions | 26 |
| Circulation | 25 |
| Circulation. Cardiovascular interventions | 14 |
| European heart journal | 14 |
Showing 5 of 124 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 1,737 | 623 | 2025-12-30 |
SEC-reported annual financials (11)
Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.
| Fiscal year | Revenue (USD) | Net income (USD) | R&D (USD) |
|---|---|---|---|
| 2025 | 6,067,600,000 | 1,073,500,000 | 1,079,200,000 |
| 2024 | 5,439,500,000 | 4,174,600,000 | 1,053,000,000 |
| 2023 | 5,010,000,000 | 1,402,400,000 | 962,900,000 |
| 2022 | 4,464,000,000 | 1,521,900,000 | 843,600,000 |
| 2021 | 5,232,500,000 | 1,503,100,000 | 903,100,000 |
| 2020 | 4,386,300,000 | not reported | 760,700,000 |
| 2019 | 4,348,000,000 | not reported | 752,700,000 |
| 2018 | 3,722,800,000 | not reported | 622,200,000 |
| 2017 | 3,435,300,000 | not reported | 552,600,000 |
| 2016 | 2,963,700,000 | not reported | 442,200,000 |
Showing 10 of 11 fiscal years.
Financing and grant events (14)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2025-08-19 | Other financing | not disclosed | Sec extracted |
| 2025-07-21 | Follow-on offering | not disclosed | Edgar offerings |
| 2024-09-03 | Other financing | not disclosed | Sec extracted |
| 2024-09-03 | Other financing | not disclosed | Sec extracted |
| 2024-07-24 | Other financing | not disclosed | Sec extracted |
Showing 5 of 14 events.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 24 |
FDA recalls (95)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Class II | 2026-03-27 |
| Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No. | Class I | 2025-05-14 |
| Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No | Class I | 2025-05-14 |
| Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No | Class I | 2025-05-14 |
| Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No | Class I | 2025-05-14 |
Showing 5 of 95 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 8 | 2020-10-07 |
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| EDWARDS LIFESCIENCES LLC | IRVINE, US | FDA | |
| Edwards Lifesciences LLC | Draper, US | FDA |
Climate targets, as filed (1)
| Reporting year | Net-zero target |
|---|---|
| 2025 | not disclosed |
Workforce and board diversity, as filed (1)
| Reporting year | Workforce % women | Board % women |
|---|---|---|
| 2025 | not disclosed | not disclosed |
Organization relationships (8)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Icon Plc | Uses vendor | 1 |
| University of Michigan | Co sponsors trial with | 1 |
| Edwards Lifesciences (Switzerland) | Ultimate parent of | 1 |
| Edwards Lifesciences (United Kingdom) | Ultimate parent of | 1 |
| American College of Cardiology | Co sponsors trial with | 1 |
Showing 5 of 8 relationships.
Latest dated events (2,082)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2028-06 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2027-01 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-10-30 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-10-15 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-10 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 2,082 events.
Biomarker capability evidence (73)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| APELA | Trial collaborator | Named in trial inclusion criteria |
| BTBD8 | Trial collaborator | Named in trial inclusion criteria |
| CPAP | Trial sponsor | Named in trial inclusion criteria |
| NPPA | Trial collaborator | Named in trial inclusion criteria |
| NPPB | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 73 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, approved assets, fda warning letters, fda untitled letters, clia clinical laboratory certificates, and biomarkers this organization publishes on.