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intravascular access introducer sheath
Applied Medical Resources
Summary: The intravascular access introducer sheath by Applied Medical Resources is used for vascular access in endovascular procedures. Key evidence highlights its role in rapid femoral artery access for procedures like REBOA.
FDA Clearance Information
Pathway
510K
Number
K041506 ↗
Decision Date
October 15, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The intravascular access introducer sheath was cleared by the FDA via the 510(k) pathway on October 15, 2004. It is manufactured by Applied Medical Resources and classified as a Class 2 device.
What It Is
The intravascular access introducer sheath is a medical device designed to facilitate vascular access during endovascular procedures. It is primarily used to introduce catheters or other instruments into the vascular system.
Clinical Applications
This device is commonly used in scenarios requiring rapid vascular access, such as in trauma settings for procedures like resuscitative endovascular balloon occlusion of the aorta (REBOA). It is also utilized in endovascular interventions in challenging anatomical areas.
Evidence Summary
The literature includes 11 studies, comprising randomized controlled trials, case reports, and prospective studies, published between 2021 and 2024. These studies explore various clinical applications and outcomes associated with the device.
Reported Outcomes
Published studies report successful stabilization of hemodynamics and avoidance of surgical retroperitoneal exposure in trauma cases using the device. The device has been shown to facilitate rapid and effective vascular access in emergency settings.
Safety Profile
Reported complications include no significant adverse events in the studies reviewed. The device has been associated with a favorable safety profile in the context of its intended use.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device, with a need for larger, more comprehensive trials to better understand long-term outcomes and potential complications.
Frequently Asked Questions
What are the clinical indications for intravascular access introducer sheath?
The device is indicated for use in procedures requiring vascular access, such as endovascular interventions and trauma management, including REBOA.
What outcomes have been reported in clinical studies?
Studies have reported successful hemodynamic stabilization and avoidance of more invasive surgical procedures in trauma settings.
What complications have been reported?
Safety data from the evidence indicates no significant complications associated with the device in the reviewed studies.
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.