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modification to short introducer sheath
Rex Medical, L.P.
Summary: The modification to the short introducer sheath by Rex Medical, L.P. is a device used primarily in embolization procedures. Key evidence highlights its application in various clinical scenarios with a focus on safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K042399 ↗
Decision Date
December 17, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on December 17, 2004. It is manufactured by Rex Medical, L.P. and is classified as a Class 2 device under product code DYB.
What It Is
The modification to the short introducer sheath is designed to facilitate the introduction of catheters and other devices into the vascular system. It is primarily used in embolization procedures, providing a conduit for device delivery.
Clinical Applications
Commonly used in procedures involving embolization coils, the device is applicable in scenarios requiring vascular access and device delivery, such as endovascular interventions and aortic aneurysm repairs.
Evidence Summary
The literature includes 9 studies, comprising RCTs, case series, and other types, spanning from 2008 to 2024. These studies provide insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report the device's efficacy in facilitating vascular access and device delivery in embolization procedures. It has been shown to be effective in various clinical settings, including aortic aneurysm repair and cryoablation.
Safety Profile
Reported complications include technical pitfalls during device deployment and challenges in femoral venous access. However, the overall safety profile is consistent with similar devices in its class.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up in some studies. Further research is needed to establish comprehensive safety and efficacy profiles across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for modification to short introducer sheath?
The device is indicated for use in procedures requiring vascular access, such as embolization and endovascular interventions.
What outcomes have been reported in clinical studies?
Studies have reported effective facilitation of vascular access and device delivery, particularly in embolization and aortic aneurysm repair.
What complications have been reported?
Safety data indicate potential complications such as technical deployment issues and challenges in venous access.
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.