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xcath
Alseal
Summary: The xcath by Alseal is a Class 2 embolization device cleared by the FDA for use in embolization-coils. Key evidence includes studies on its application in stroke treatment.
FDA Clearance Information
Pathway
510K
Number
K133296 ↗
Decision Date
February 14, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The xcath was cleared by the FDA through the 510(k) pathway on February 14, 2014. It is manufactured by Alseal and classified as a Class 2 device.
What It Is
The xcath is a medical device designed for embolization procedures, specifically using coils. It is intended for use in interventional radiology to occlude blood vessels in various clinical scenarios.
Clinical Applications
Commonly used in the treatment of vascular abnormalities such as aneurysms, the xcath is applied in scenarios requiring precise embolization to prevent or control bleeding.
Evidence Summary
The available literature includes 10 studies, primarily from 2025, encompassing various study types such as RCTs and retrospective analyses. These studies focus on the device's application in stroke and aneurysm treatment.
Reported Outcomes
Published studies report that the xcath is effective in achieving successful embolization in targeted vascular territories. Outcomes include improved procedural success rates in embolization and potential benefits in stroke management.
Safety Profile
Reported complications include challenges in device navigation and deployment in tortuous vasculature. However, specific adverse events related to the xcath itself are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of long-term follow-up data and specific safety outcomes directly attributed to the xcath. Further research is needed to establish comprehensive safety profiles and efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for xcath?
The xcath is indicated for use in embolization procedures, particularly in the treatment of aneurysms and vascular malformations.
What outcomes have been reported in clinical studies?
Studies report successful embolization and procedural success in stroke and aneurysm treatment.
What complications have been reported?
Challenges in device navigation and deployment have been noted, but specific complications related to the xcath are not detailed in the evidence.
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.