Organization (Industry)
VOLCANO SRL
ClinicalTrials.gov lists VOLCANO SRL 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 0.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers VOLCANO SRL: 14 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (26)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Coronary Disease | 13 |
| Coronary Artery Disease | 10 |
| Coronary Stenosis | 3 |
| Angina Pectoris | 2 |
| Angina, Stable | 2 |
Showing 5 of 26 disease areas.
Trials by start year as sponsor or collaborator (13)
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 |
|---|---|
| 2019 | 1 |
| 2018 | 1 |
| 2017 | 3 |
| 2016 | 2 |
| 2015 | 2 |
| 2014 | 6 |
| 2013 | 2 |
| 2012 | 1 |
| 2011 | 1 |
| 2010 | 3 |
Showing 10 of 13 years.
Recruitment duration, a model prediction: none of the 14 trials evaluated at the 2026-10-09 snapshot is predicted and still running. 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 |
|---|---|
| 1 of 4 hit target (n=4) | 1 of 4 on time (n=4) |
Journals published in (32)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| JACC. Cardiovascular interventions | 11 |
| Journal of the American College of Cardiology | 11 |
| Circulation | 10 |
| The New England journal of medicine | 8 |
| Journal of vascular surgery | 6 |
Showing 5 of 32 journals.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 6 |
FDA recalls (31)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use. | Class II | 2025-06-13 |
| Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 | Class II | 2022-05-16 |
| Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 | Class III | 2022-05-13 |
| Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797 | Class III | 2022-05-13 |
| MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems | Class III | 2022-02-03 |
Showing 5 of 31 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 4 | 2023-12-15 |
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| VOLCANO CORPORATION | Rancho Cordova, US | FDA | |
| Volcano Corporation | San Diego, US | FDA |
Organization relationships (1)
| Related organization | Relationship | Evidence |
|---|---|---|
| University at Buffalo | Co sponsors trial with | 1 |
Latest dated events (67)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2025-06-13 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-02-21 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-01-08 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2023-12-15 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2022-05-16 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 67 events.
Biomarker capability evidence (20)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| BTK | Trial sponsor | Named in trial inclusion criteria |
| DLD | Trial sponsor | Named in trial inclusion criteria |
| DLD | Trial collaborator | Named in trial inclusion criteria |
| LAD1 | Trial collaborator | Named in trial inclusion criteria |
| LAD1 | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 20 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, clia clinical laboratory certificates, and biomarkers this organization publishes on.