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scepter mini occlusion balloon catheter
Microvention
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 510K
Number K182829 ↗
Decision Date July 10, 2019
Product Code DQY
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.
Clinical Applications
Commonly used in interventional neuroradiology, the Scepter Mini is employed in the treatment of dural arteriovenous fistulas and spinal arteriovenous fistulas. It is particularly useful in scenarios where distal access and precise delivery of embolic agents are required.
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.
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.