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Celt Acd Vascular Closure Device
Product: Celt ACD PLUS Vascular Closure Device 7F — all models and sizes
Summary: The Celt ACD Vascular Closure Device is used for vascular closure following catheterization procedures. It is primarily used to achieve rapid hemostasis. Key evidence highlights its efficacy and safety in various clinical settings.
FDA Clearance Information
Pathway ?
PMA
Number ?
P150006 ↗
Decision Date ?
June 27, 2017
Product Code ?
MGB Device, Hemostasis, Vascular
Device Class ?
Class 3
Evidence ?
0 studies
The Celt ACD Vascular Closure Device was cleared via the PMA pathway on June 27, 2017. It is manufactured by Vasorum and classified as a Class III medical device.
What It Is
The Celt ACD Vascular Closure Device is a vascular closure device designed to achieve hemostasis after catheterization procedures. It employs a clip-based mechanism to close the puncture site in the artery, facilitating quicker recovery and ambulation.
FDA-Cleared Indications
- The 5F, 6F, and 7F CELT ACD Vascular Closure Devices are indicated for vascular closure after catheterization procedures involving femoral artery access.
- The FDA approval includes the addition of a 7F size CELT ACD Vascular Closure Device.
- The approval also includes specified minor manufacturing and design changes to the 5F, 6F, and 7F devices.
Clinical Applications
- Closure of a femoral artery puncture site after diagnostic angiography.
- Closure after endovascular catheterization procedures performed through femoral arterial access.
- Hemostasis after procedures using compatible 5F, 6F, or 7F access systems, according to the device labeling.
- Supporting earlier ambulation after femoral artery catheterization when adequate hemostasis has been achieved.
Evidence Summary
The available literature includes six studies, comprising retrospective analyses, case reports, and other observational studies, published between 2021 and 2025. These studies evaluate the device's efficacy and safety in various clinical scenarios.
Reported Outcomes
Published studies report that the Celt ACD Vascular Closure Device is effective in achieving rapid hemostasis in both antegrade and retrograde femoral punctures. It has been successfully used in challenging patient populations, including those with peripheral artery disease and complex vascular anatomy.
Safety Profile
Reported complications include device maldeployment and embolization, which can lead to significant patient morbidity. Surgical and endovascular retrieval methods have been documented in cases of device embolization.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of much of the data. Further research is needed to establish long-term outcomes and to compare the device's performance with other vascular closure devices.
Practical Considerations
- Available device sizes include 5F, 6F, and 7F; the selected size must match the access sheath or catheter and the device labeling.
- The device is intended for femoral arterial access and should not be assumed to be appropriate for other access sites or vessels without specific labeling and clinician judgment.
- Adequate vessel size, puncture location, and access-site anatomy must be confirmed before deployment; a high, low, calcified, diseased, or otherwise unsuitable puncture may increase complications.
- The device is a mechanical implant, so MRI safety should be verified in the current manufacturer’s instructions for use before MRI. Do not assume MRI compatibility without checking the specific device labeling.
- Potential complications include bleeding, hematoma, infection, vessel narrowing or occlusion, distal embolization, pseudoaneurysm, arteriovenous fistula, and need for additional treatment.
Frequently Asked Questions
What are the clinical indications for Celt ACD Vascular Closure Device?
The device is indicated for vascular closure following catheterization procedures, particularly in femoral artery access.
What outcomes have been reported in clinical studies?
Studies have reported effective hemostasis and successful use in complex patient populations, including those with peripheral artery disease.
What complications have been reported?
Complications such as device maldeployment and embolization have been reported, requiring surgical or endovascular retrieval.
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.