Organization (Industry)
Bolton Medical, Inc. (United States)
ClinicalTrials.gov lists Bolton Medical, Inc. (United States) as lead sponsor of 14 trials.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
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: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.6 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Bolton Medical, Inc. (United States): 14 lead-sponsored trials and 1 legal-entity registration.
Disease areas (11)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Aortic Aneurysm | 16 |
| Aortic Aneurysm, Thoracic | 9 |
| Aortic Aneurysm, Abdominal | 8 |
| Aortic Dissection | 3 |
| Penetrating Atherosclerotic Ulcer | 3 |
Showing 5 of 11 disease areas.
Trials by start year as sponsor or collaborator (11)
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
| Year | Trials started |
|---|---|
| 2025 | 1 |
| 2023 | 1 |
| 2021 | 2 |
| 2019 | 1 |
| 2017 | 5 |
| 2016 | 1 |
| 2014 | 2 |
| 2013 | 1 |
| 2012 | 1 |
| 2011 | 1 |
Showing 10 of 11 years.
Recruitment duration, a model prediction: 2 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. 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.
| Enrollment | Timeline |
|---|---|
| 67% hit target (n=6) | 17% on time (n=6) |
Journals published in (10)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Journal of vascular surgery | 11 |
| European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery | 3 |
| Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists | 3 |
| The Journal of thoracic and cardiovascular surgery | 2 |
| American journal of kidney diseases : the official journal of the National Kidney Foundation | 1 |
Showing 5 of 10 journals.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 5 |
FDA recalls (5)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U | Class I | 2026-04-22 |
| RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S; (f) Part number 28-M4-38-145-34S; (g) Part number 28-M4-38-190-38S; (h) Part number 28-M4-44-105-44S; (i) Part number 28-N4-22-099-22S; (j) Part number 28-N4-22-159-22S; (k) Part number 28-N4-24-099-24S; (l) Part number 28-N4-28-204-24S (m) Part number 28-N4-30-164-30U; (n) Part number 28-N4-32-164-28S; (o) Part number 28-N4-34-154-34U; (p) Part number 28-N4-34-209-30S; (q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and (r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC; | Class II | 2024-02-22 |
| The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanced under fluoroscopy to the location of the infrarenal aneurysm. The stent-graft is deployed at the intended location and creates a blood flow channel, excluding the aneurysm from blood pressure and flow. | Class II | 2023-05-03 |
| RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX | Class II | 2022-12-20 |
| RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX | Class II | 2022-12-20 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 1 | 2023-03-31 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| BOLTON MEDICAL, INC. | Sunrise, US | FDA |
Latest dated events (28)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-04-22 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-11-18 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2024-02-22 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2023-05-03 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2023-03-31 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 28 events.
Biomarker capability evidence (6)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| NBN | Trial collaborator | Named in trial inclusion criteria |
| NBN | Trial sponsor | Named in trial inclusion criteria |
| STYK1 | Trial collaborator | Named in trial inclusion criteria |
| NBN | Trial sponsor | Mentioned in trial text |
| NBN | Trial collaborator | Mentioned in trial text |
Showing 5 of 6 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, approved assets, us granted patents, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.