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in-line hemostasis valve
Merit Medical Systems
Summary: The in-line hemostasis valve by Merit Medical Systems is a device used to control bleeding during vascular procedures. It was FDA 510k cleared in 2000. Key evidence includes studies on platelet adhesion and hemostatic function.
FDA Clearance Information
Pathway 510K
Number K990975 ↗
Decision Date March 15, 2000
Product Code DYB
Device Class Class 2
Evidence 0 studies
The in-line hemostasis valve was cleared by the FDA via the 510k pathway on March 15, 2000. It is manufactured by Merit Medical Systems and classified as a Class 2 device.
What It Is
The in-line hemostasis valve is designed to prevent blood loss during vascular procedures by maintaining hemostasis. It is used in conjunction with catheters and other vascular access devices to minimize bleeding.
Clinical Applications
This device is commonly used in interventional cardiology and radiology procedures where vascular access is required. It helps maintain a bloodless field and reduces the risk of air embolism.
Evidence Summary
The available literature includes 9 studies, with a mix of RCTs, prospective, and retrospective studies. The studies span from 1992 to 2023, focusing on hemostatic function and platelet interaction.
Reported Outcomes
Published studies report that the in-line hemostasis valve effectively reduces platelet adhesion and improves hemostatic control during procedures. It has been shown to maintain vascular integrity and minimize bleeding complications.
Safety Profile
Reported complications include potential for thrombogenesis if not used correctly, as indicated by studies on platelet adhesion. However, no significant adverse events have been consistently reported across studies.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some cases. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for in-line hemostasis valve?
The device is indicated for use in vascular procedures to maintain hemostasis and prevent blood loss.
What outcomes have been reported in clinical studies?
Studies report effective reduction in platelet adhesion and improved hemostatic control during procedures.
What complications have been reported?
Safety data indicate potential thrombogenesis if not used correctly, but no significant adverse events have been consistently reported.
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.