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short introducer sheath
Rex Medical
Summary: The short introducer sheath by Rex Medical is a device used in vascular procedures to facilitate the introduction of catheters and other devices. Key evidence highlights its use in complex cardiac and vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K032569 ↗
Decision Date
September 16, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The short introducer sheath by Rex Medical was cleared via the FDA 510(k) pathway on September 16, 2003. It is classified as a Class 2 device under product code DYB.
What It Is
The short introducer sheath is a medical device designed to provide a conduit for the insertion of catheters and other instruments into the vascular system. It is primarily used in interventional cardiology and radiology to facilitate access to the vascular system.
Clinical Applications
Common clinical scenarios for the short introducer sheath include its use in procedures such as embolization, stenting, and endomyocardial biopsy. It is particularly useful in accessing difficult vascular targets.
Evidence Summary
The available literature includes a mix of study types, such as RCTs and case series, with a total of 8 studies ranging from 1987 to 2009. These studies explore various applications of the sheath in vascular interventions.
Reported Outcomes
Published studies report that the short introducer sheath is effective in facilitating access to complex vascular targets, particularly in congenital heart disease and carotid artery stenting. Its use has been associated with improved procedural success rates.
Safety Profile
Reported complications include potential vascular injury and device-related issues, although specific adverse events are not detailed in the provided evidence. Overall, the device is considered safe when used appropriately.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for short introducer sheath?
The short introducer sheath is indicated for use in vascular procedures requiring access to the vascular system, such as embolization and stenting.
What outcomes have been reported in clinical studies?
Studies have reported successful access to complex vascular targets and improved procedural outcomes in interventions like carotid artery stenting.
What complications have been reported?
Reported complications include potential vascular injury, although specific adverse events are not detailed in the provided 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.