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Organization (Industry)

ABIOMED, INC.

ClinicalTrials.gov lists ABIOMED, INC. as lead sponsor of 33 trials.

US Industry Manufacturer
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7 0 2004 2026

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: 1 registered with a 2026 start date. The dashed outline is the pace from the 1 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 4.0 trial starts a year over the five years to September, under the 5 a year the method needs.

Logo ABIOMED, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.

This page covers ABIOMED, INC.: 33 lead-sponsored trials and 3 legal-entity registrations. Part of KENVUE INC..

Related companies are recorded in the same corporate group by GLEIF, ROR or a curator but are not grouped here; they are listed below with their own counts and are not included in the figures above.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

Disease areas (25)

Shown in this order: most trials first (counted at this company's own legal-entity record, not the consolidated group).

Disease areas
Disease area Trials
Myocardial Infarction 19
Shock, Cardiogenic 14
Heart Failure 12
ST Elevation Myocardial Infarction 6
Non-ST Elevated Myocardial Infarction 4

Showing 5 of 25 disease areas.

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Trials by start year as sponsor or collaborator (18)

Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Show the table of trials by start year as sponsor or collaborator
Trials by start year as sponsor or collaborator
Year Trials started
2026 (partial year) 1
2025 3
2024 4
2023 5
2022 7
2021 4
2020 4
2019 3
2017 3
2016 1

Showing 10 of 18 years.

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Prediction, not a registry value: median of 17 months from start to primary completion across 6 trials still running at the 2026-10-09 snapshot; registered median of 27 months across 16 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

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.

Sponsor delivery record
Enrollment Timeline
55% hit target (n=11) 50% on time (n=10)

FDA inspection record (1)

FDA inspection record
Latest classification Inspections
OAI 9

FDA recalls (79)

Shown in this order: most recent first.

FDA recalls
Product Classification Initiated
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories Class I 2026-06-11
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories Class I 2026-06-11
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories Class I 2026-06-11
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories Class I 2026-06-11
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories Class I 2026-06-11

Showing 5 of 79 recalls.

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Manufacturing and distribution sites (1)

Manufacturing and distribution sites
Facility Location Regulators Member organization
ABIOMED, INC. DANVERS, US FDA

CLIA clinical laboratory certificates (1)

CLIA clinical laboratory certificates
Lab Certificate Status
ABIOMED, INC Certificate of waiver Terminated

Biomarker capability evidence (52)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
CPO Trial collaborator Named in trial inclusion criteria
CPOX Trial collaborator Named in trial inclusion criteria
DLD Trial collaborator Named in trial inclusion criteria
DLD Trial sponsor Named in trial inclusion criteria
DLD Trial sponsor Named in trial inclusion criteria

Showing 5 of 52 evidence rows.

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Not on this page

Checked, with nothing recorded for this organization: companies grouped under this page, active development programs, approved assets, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, and organization relationships.

Counted at group level under Johnson & Johnson: journals published in, us granted patents, latest dated events, and biomarkers this organization publishes on.