đź“Š Evidence-Based Reference
Angio-Seal Vascular Closure Device
Summary: The Angio-Seal is a vascular closure device used to achieve hemostasis after endovascular procedures. Key evidence highlights its efficacy in managing complications such as iatrogenic perforations.
FDA Clearance Information
Pathway ?
PMA
Number ?
P930038 ↗
Decision Date ?
August 7, 2025
Product Code ?
MGB Device, Hemostasis, Vascular
Device Class ?
Class 3
Evidence ?
19 studies
The Angio-Seal vascular closure device by Terumo Medical received FDA premarket approval (PMA) on August 7, 2025. It is classified as a Class 3 medical device.
What It Is
The Angio-Seal is a vascular closure device designed to achieve hemostasis following endovascular procedures. It utilizes a collagen plug to seal the puncture site, facilitating rapid hemostasis and reducing time to ambulation.
FDA-Cleared Indications
- The FDA record identifies a manufacturing change to the hemostasis cap component of the Insertion Sheath subassembly.
Clinical Applications
- No specific clinical application is stated in the FDA indication text provided for this record.
- The device category is used for hemostasis at selected arterial access sites after endovascular procedures, when consistent with the applicable product labeling.
Reported off-label uses
- Use in selected access-site complications, such as iatrogenic arterial perforation, has been described in clinical practice and literature but may be off-label depending on the specific device, anatomy, and technique.
- Use in access sites or clinical situations outside the approved labeling has been reported, but should be determined by the treating clinician.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies, comprising case reports, retrospective analyses, and other study types, spanning from 2021 to 2025. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report successful hemostasis and closure of vascular access sites using the Angio-Seal device. Notably, it has been effective in managing iatrogenic right ventricular perforations and reducing hemorrhage-related complications.
Safety Profile
Reported complications include acute limb ischemia and arterial occlusion at the access site. These events, although uncommon, highlight the need for careful patient selection and monitoring.
Evidence Limitations
The evidence is limited by the predominance of case reports and retrospective studies, which may not fully capture the device's efficacy and safety profile. Further large-scale, prospective studies are needed to validate these findings.
Practical Considerations
- Use only with the compatible Angio-Seal device size, sheath, guidewire, and access-site anatomy specified in the current instructions for use.
- The operator should confirm appropriate arterial access, vessel size, puncture location, and absence of contraindications before deployment.
- Potential complications include bleeding, hematoma, infection, arterial stenosis or occlusion, distal embolization, device malfunction, and allergic or inflammatory reactions.
- MRI safety depends on the specific implanted or retained components and the current manufacturer labeling; verify the applicable MRI conditions before scanning.
- A collagen-based closure device does not replace manual compression, endovascular treatment, surgery, or other management when bleeding or vascular injury persists.
Linked Studies (19)
PubMed • 2025
Angio-Seal Vascular Closure Device for Percutaneous Management of Iatrogenic Right Ventricular Perforation During Pericardiocentesis.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Risk Factors for Puncture Site Complications Using the Angio-Seal Closure Device in Endovascular Therapy: A Single-center Analysis.
Journal of neuroendovascular therapy
Retrospective View Source →PubMed • 2023
Complications with the use of Angio-Seal vascular closure device and their management.
Journal of clinical imaging science
View Source →PubMed • 2022
Percutaneous closure of an iatrogenic right ventricular perforation with an angio-seal vascular closure device: a case report.
European heart journal. Case reports
Case Report View Source →PubMed • 2021
Single Angio-Seal vascular closure device for transfemoral access exceeding 8F.
Journal of cardiology
Retrospective View Source →PubMed • 2019
Long Term Outcome after Application of the Angio-Seal Vascular Closure Device in Minipigs.
PloS one
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2015
Complications with Angio-Seal™ vascular closure devices compared with manual compression after diagnostic cardiac catheterization and percutaneous coronary intervention.
Journal of interventional cardiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2013
Use of the 8-F angio-seal vascular closure device in large-caliber arteriotomies.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2012
Use of Angio-Seal closure device when the arteriotomy is above or below the common femoral artery.
Clinical cardiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2011
The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device.
The Journal of invasive cardiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2007
A cost-minimization analysis of the angio-seal vascular closure device following percutaneous coronary intervention.
The American journal of cardiology
View Source →PubMed • 2007
Treatment of an Angio-Seal-related vascular complication using the SilverHawk plaque excision system: a case report.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2001
Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices.
The Journal of invasive cardiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 1995
Puncture site hemostasis.
The Journal of invasive cardiology
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease
View Source →Frequently Asked Questions
What are the clinical indications for Angio-Seal?
The Angio-Seal is indicated for achieving hemostasis following endovascular procedures requiring arterial access.
What outcomes have been reported in clinical studies?
Studies report effective hemostasis and closure of access sites, with successful management of complications like iatrogenic perforations.
What complications have been reported?
Safety data indicate complications such as acute limb ischemia and arterial occlusion, necessitating careful patient monitoring.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.