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introducer sheath vessel dilator
Boston Scientific
Summary: The introducer sheath vessel dilator by Boston Scientific is a device used primarily for vascular access and embolization procedures. Key evidence highlights its use in preventing type II endoleaks during endografting.
FDA Clearance Information
Pathway
510K
Number
K992309 ↗
Decision Date
October 7, 1999
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer sheath vessel dilator was cleared by the FDA through the 510(k) pathway on October 7, 1999. It is manufactured by Boston Scientific and classified as a Class 2 medical device.
What It Is
The introducer sheath vessel dilator is a medical device designed to facilitate the insertion of catheters or other instruments into blood vessels. It is commonly used in interventional radiology and cardiology for procedures requiring vascular access.
Clinical Applications
This device is often used in procedures such as embolization, where it aids in the delivery of coils or other embolic agents. It is also utilized in endovascular interventions to prevent complications like type II endoleaks.
Evidence Summary
The available literature includes a mix of study types, with three studies identified. These studies span from 1997 to 2006 and include both animal and human research, focusing on procedural applications and outcomes.
Reported Outcomes
Published studies report that the introducer sheath vessel dilator is effective in providing stable vascular access during procedures. In one study, it was used successfully in rabbits for airway access, demonstrating its versatility in clinical applications.
Safety Profile
Reported complications include potential risks associated with vascular access, such as bleeding or infection. However, specific adverse events related to the device itself were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for introducer sheath vessel dilator?
The device is indicated for use in vascular access procedures, particularly in embolization and endovascular interventions.
What outcomes have been reported in clinical studies?
Studies have shown effective use in providing vascular access and preventing type II endoleaks during endografting.
What complications have been reported?
Safety data indicate potential risks such as bleeding or infection, though specific device-related complications were not detailed.
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.