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expanding vascular sheath
Applied Medical
Summary: The expanding vascular sheath by Applied Medical is a device used to facilitate vascular access, particularly in procedures like transcatheter aortic valve replacement (TAVR). Key evidence suggests it may reduce vascular complications.
FDA Clearance Information
Pathway
510K
Number
K070865 ↗
Decision Date
October 23, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The expanding vascular sheath was cleared by the FDA via the 510(k) pathway on October 23, 2007. It is manufactured by Applied Medical and classified as a Class 2 device.
What It Is
The expanding vascular sheath is designed to provide vascular access by expanding to accommodate larger instruments during procedures. It is primarily used in interventional cardiology and radiology to facilitate the introduction of devices into the vascular system.
Clinical Applications
Commonly used in procedures such as transcatheter aortic valve replacement (TAVR), the expanding vascular sheath is beneficial in patients with challenging vascular anatomy, including small or tortuous vessels.
Evidence Summary
The literature includes 14 studies, comprising various study types such as RCTs and case series, conducted between 2014 and 2023. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the expanding vascular sheath is associated with reduced rates of vascular complications in procedures like TAVR. It facilitates access in patients with peripheral vascular disease and small vessel diameter, improving procedural success rates.
Safety Profile
Reported complications include vascular injury and hematoma formation, although these are minimized with the use of the expanding sheath. The device's design aims to reduce the risk of such adverse events.
Evidence Limitations
Current evidence is limited by the variability in study designs and patient populations. Further research is needed to establish long-term outcomes and to compare the sheath's performance with alternative devices.
Frequently Asked Questions
What are the clinical indications for expanding vascular sheath?
The device is indicated for use in procedures requiring vascular access, such as TAVR, particularly in patients with small or tortuous vessels.
What outcomes have been reported in clinical studies?
Studies have reported reduced vascular complications and improved procedural success rates in TAVR when using the expanding vascular sheath.
What complications have been reported?
Safety data indicate that complications such as vascular injury and hematoma are possible but are reduced with the use of the expanding sheath.
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.