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rotating hemostatic valve
Devices For Vascular Intervention
Summary: The rotating hemostatic valve is a device used in vascular interventions to maintain hemostasis during catheterization procedures. Key evidence highlights its role in optimizing catheter manipulation and preventing complications.
FDA Clearance Information
Pathway 510K
Number K883916 ↗
Decision Date October 28, 1988
Product Code DQY
Device Class Class 2
Evidence 0 studies
The rotating hemostatic valve was cleared by the FDA through the 510(k) pathway on October 28, 1988. It is manufactured by Devices For Vascular Intervention and classified as a Class 2 device.
What It Is
The rotating hemostatic valve is designed to maintain hemostasis during catheter-based procedures by allowing for the passage of instruments while minimizing blood loss. It is commonly used in vascular interventions, particularly in procedures involving venous stents.
Clinical Applications
This device is frequently used in interventional cardiology and radiology to facilitate catheter manipulation and maintain hemostasis during procedures such as coronary angioplasty and atherectomy. It is particularly useful in complex vascular anatomies.
Evidence Summary
The literature includes six studies, comprising various study types such as RCTs and case series, with publication dates ranging from 1995 to 2024. These studies explore the device's efficacy in optimizing catheter manipulation and preventing procedural complications.
Reported Outcomes
Published studies report that the rotating hemostatic valve enhances catheter manipulation and reduces the risk of blood loss during procedures. It has been shown to improve torque transmission and prevent kinking in complex vascular anatomies.
Safety Profile
Reported complications include the separation of device components during procedures, as noted in one study. However, overall safety profiles indicate that the device effectively minimizes blood loss without significant adverse events.
Evidence Limitations
Current 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 in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for rotating hemostatic valve?
The rotating hemostatic valve is indicated for use in maintaining hemostasis during catheter-based vascular interventions, particularly in procedures involving venous stents.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved catheter manipulation and reduced blood loss during procedures, with enhanced torque transmission and prevention of kinking.
What complications have been reported?
Safety data from evidence indicate that complications may include the separation of device components during procedures, but overall adverse events are minimal.
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.