đź“Š Evidence-Based Reference
Hemostasis Valve
Applied Vascular Devices
Summary: The hemostasis valve by Applied Vascular Devices is used primarily in embolization procedures. Key evidence highlights its role in managing coil stretching complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K895214 ↗
Decision Date ?
November 14, 1989
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The hemostasis valve was cleared by the FDA through the 510(k) pathway on November 14, 1989. It is manufactured by Applied Vascular Devices and classified as a Class 2 device.
What It Is
The hemostasis valve is a medical device designed to control blood flow during vascular procedures. It is primarily used in embolization procedures to prevent blood loss and maintain a sterile field.
FDA-Cleared Indications
- Control or reduce blood loss during percutaneous vascular procedures.
- Maintain a closed, sterile pathway while catheters or other interventional devices are introduced or exchanged.
- Provide hemostatic control during catheter-based embolization procedures.
Clinical Applications
- Managing blood flow during coil embolization of intracranial aneurysms.
- Maintaining hemostasis during embolization of arteriovenous malformations.
- Controlling blood loss during uterine, prostate, ovarian-vein, or varicocele embolization.
- Maintaining a closed access system during visceral, gastrointestinal, bronchial, or splenic artery embolization.
- Managing access-site blood flow during catheter-based procedures involving selective vascular catheterization.
Evidence Summary
The literature includes 15 studies, encompassing various types such as RCTs and case series, with publication dates ranging from 2020 to 2024. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report the hemostasis valve's effectiveness in managing coil stretching during embolization procedures. The Monorail Snare Technique, highlighted in recent research, demonstrates its utility in retrieving migrated coils.
Safety Profile
Reported complications include device-related issues during embolization procedures, as noted in studies involving the Penumbra Indigo aspiration system. However, specific adverse events related to the hemostasis valve itself are not detailed in the provided evidence.
Evidence Limitations
The current evidence lacks comprehensive data on long-term outcomes and specific adverse events directly associated with the hemostasis valve. Further research is needed to establish standardized protocols and assess the device's performance across diverse patient populations.
Practical Considerations
- The valve must be compatible with the catheter, guidewire, sheath, or embolic delivery system being used; inner diameter and device profile should be checked before the procedure.
- Operators should follow the device instructions for flushing, priming, tightening, and device exchanges to reduce air entry and blood leakage.
- A hemostasis valve is an accessory, not a substitute for appropriate vascular access management, anticoagulation decisions, or treatment of an access-site complication.
- MRI safety depends on the specific valve materials and labeling. Do not assume MRI compatibility from the device category alone; verify the manufacturer’s current MR status.
- Potential problems include leakage, clot formation, air introduction, resistance during device passage, or damage to the valve during repeated exchanges.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for hemostasis valve?
The hemostasis valve is indicated for use in embolization procedures, particularly in managing coil stretching complications.
What outcomes have been reported in clinical studies?
Studies report effective management of coil stretching and successful retrieval of migrated coils using the Monorail Snare Technique.
What complications have been reported?
Safety data from evidence indicate complications related to embolization procedures, though specific adverse events for the hemostasis valve are 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.