đź“Š Evidence-Based Reference
In-Line Hemostasis Valve
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a hemostasis valve during vascular procedures involving catheter or other vascular access-device placement.
- Control or reduce blood loss at the access system while permitting passage and manipulation of compatible devices.
- Help limit air entry into the vascular system when used as part of a closed vascular access system.
Clinical Applications
- Maintaining hemostasis during diagnostic angiography and endovascular interventions.
- Use with catheter-based vascular access systems in interventional radiology.
- Use with catheter-based systems during interventional cardiology procedures.
- Maintaining a relatively bloodless access field during embolization and other endovascular treatments.
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.
Practical Considerations
- Confirm the valve's inner diameter, connector type, and compatibility with the sheath, catheter, guidewire, and other devices being used.
- Use sterile technique and flush the system as directed to reduce the risk of air entry, clot formation, and device obstruction.
- Inspect the valve before use and do not use it if the package is damaged, expired, or otherwise compromised.
- The FDA record and supplied information do not establish MRI safety; follow the specific product labeling and institutional MRI screening policy.
- Potential problems include leakage, bleeding, air entry, thrombus formation, difficult device passage, or damage to the catheter or guidewire.
Procedures that use this device
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.