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Scepter Mini Occlusion Balloon Catheter
Summary: The Scepter Mini Occlusion Balloon Catheter by Microvention is a dual-lumen balloon microcatheter used primarily for endovascular embolization. Key evidence highlights its use in challenging vascular anatomies with favorable outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K182829 ↗
Decision Date ?
July 10, 2019
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Scepter Mini Occlusion Balloon Catheter was cleared via the FDA 510(k) pathway on July 10, 2019. It is manufactured by Microvention and classified as a Class 2 medical device.
What It Is
The Scepter Mini is a dual-lumen balloon microcatheter designed for endovascular procedures. It facilitates embolization by providing flow arrest and preventing reflux during the delivery of liquid embolic agents, particularly in complex vascular anatomies.
FDA-Cleared Indications
- Used for the controlled delivery of embolic materials during endovascular procedures.
- Used to temporarily occlude or reduce blood flow in a vessel during embolization.
- Intended for percutaneous intravascular use under imaging guidance.
Clinical Applications
- Flow control during endovascular embolization.
- Delivery of liquid embolic agents through a dual-lumen microcatheter.
- Temporary vessel occlusion to help limit reflux during embolic-agent delivery.
- Use in selected vascular anatomies requiring small-caliber catheter access and balloon-assisted control.
Reported off-label uses
- Embolization of dural arteriovenous fistulas.
- Embolization of spinal arteriovenous fistulas.
- Balloon-assisted embolization of selected brain and spinal vascular malformations.
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 available literature includes a mix of study types such as retrospective and prospective studies, with a total of 9 studies published between 2024. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the Scepter Mini provides effective embolization in complex vascular anatomies, with improved distal navigability and precise delivery of embolic agents. Favorable outcomes have been noted in the treatment of cerebrospinal lesions and arteriovenous fistulas.
Safety Profile
Reported complications include risks associated with transvenous embolization such as hemorrhage, venous redirection, and neurologic deterioration. However, the Scepter Mini's design aims to mitigate these risks by enhancing control during procedures.
Evidence Limitations
The evidence is limited by small sample sizes and the need for larger multicenter trials to validate findings. Further research is needed to explore long-term outcomes and compare the Scepter Mini with other embolization devices.
Practical Considerations
- The catheter is a dual-lumen system: one lumen delivers embolic material and the other inflates the occlusion balloon.
- The treating physician must confirm compatibility with the planned guide catheter, guidewire, embolic agent, and imaging system before use.
- Balloon inflation requires careful monitoring because excessive inflation or prolonged occlusion may injure the vessel or impair downstream blood flow.
- MRI safety depends on the specific catheter configuration and whether the device remains in place; follow the current manufacturer labeling and institutional MRI policy.
- Contraindications and precautions include inability to safely access the target vessel, severe vessel tortuosity or stenosis, vessel injury, uncorrected bleeding risk, and allergy or intolerance to relevant contrast or procedural materials.
Frequently Asked Questions
What are the clinical indications for Scepter Mini Occlusion Balloon Catheter?
The Scepter Mini is indicated for use in endovascular embolization procedures, particularly in the treatment of dural and spinal arteriovenous fistulas.
What outcomes have been reported in clinical studies?
Studies report effective embolization with improved navigability and precise delivery of embolic agents, resulting in favorable outcomes for cerebrospinal lesions.
What complications have been reported?
Safety data indicate potential complications such as hemorrhage, venous redirection, and neurologic deterioration, although the device is designed to minimize these risks.
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.