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rotating hemostatic valve
Devices For Vascular Intervention
Summary: The rotating hemostatic valve is a device used in vascular interventions to prevent blood loss during catheterization procedures. Key evidence highlights its role in enhancing catheter manipulation and preventing complications.
FDA Clearance Information
Pathway
510K
Number
K911678 ↗
Decision Date
July 12, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The rotating hemostatic valve by Devices For Vascular Intervention was cleared via the FDA 510(k) pathway on July 12, 1991. It is classified as a Class 2 device under product code DYB.
What It Is
The rotating hemostatic valve is designed to maintain hemostasis during catheter-based procedures by preventing blood leakage while allowing for the manipulation of guidewires and catheters. It is commonly used in interventional cardiology and radiology.
Clinical Applications
This device is typically used in procedures requiring vascular access, such as coronary angioplasty and atherectomy, where maintaining a bloodless field is crucial. It is particularly useful in complex catheter manipulations.
Evidence Summary
The literature includes six studies ranging from 1995 to 2024, covering various aspects of catheter-based interventions. Study types include retrospective analyses and case series, focusing on device manipulation and safety.
Reported Outcomes
Published studies report that the rotating hemostatic valve improves catheter manipulation, particularly in challenging anatomical scenarios. It has been shown to enhance torque transmission and reduce kinking during procedures.
Safety Profile
Reported complications include device separation during directional atherectomy, as noted in one study. However, overall safety data is limited, with few adverse events documented in the available literature.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of the device.
Frequently Asked Questions
What are the clinical indications for rotating hemostatic valve?
The device is indicated for use in vascular interventions to maintain hemostasis during catheter manipulations.
What outcomes have been reported in clinical studies?
Studies have reported improved catheter manipulation and reduced kinking, enhancing procedural success.
What complications have been reported?
Safety data indicates potential device separation during use, though such events are rare.
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.