📊 Evidence-Based Reference
Valved Tearway Introducer
Medcomp
Summary: The valved tearway introducer by Medcomp is a device used primarily in embolization procedures. It is FDA 510k cleared and supported by 10 studies, focusing on its clinical applications and safety profile.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K090394 ↗
Decision Date ?
September 1, 2009
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The valved tearway introducer was cleared by the FDA through the 510k pathway on September 1, 2009. It is manufactured by Medcomp and classified as a Class 2 medical device.
What It Is
The valved tearway introducer is a medical device designed to facilitate the introduction of catheters or other devices into the vascular system. It features a valve mechanism to prevent blood loss during procedures and is primarily used in embolization-coil applications.
FDA-Cleared Indications
- Percutaneous introduction of catheters and other intravascular devices into the vascular system.
- Use during procedures requiring vascular access and maintenance of hemostasis through an integral valve.
- Use with compatible embolization devices, including embolization coils, when specified by the product labeling.
Clinical Applications
- Vascular access for catheter-based embolization procedures.
- Introduction of diagnostic or therapeutic catheters into the vasculature.
- Maintaining access-site hemostasis while devices are exchanged during an endovascular procedure.
Reported off-label uses
- Access for selected endovascular interventions beyond embolization when the introducer's size, valve, and compatibility are appropriate.
- Temporary access for delivery of other compatible intravascular devices in clinical practice.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series, published between 2009 and 2025. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the valved tearway introducer is effective in maintaining vascular access with minimal blood loss. It has been successfully used in complex interventional procedures, demonstrating reliability and ease of use.
Safety Profile
Reported complications include potential vascular injury and thrombosis, which are inherent risks in procedures involving vascular access. However, the device's design aims to minimize these risks.
Evidence Limitations
The available evidence is limited by the small sample sizes and lack of long-term follow-up in some studies. Further research is needed to fully understand the device's long-term safety and efficacy.
Practical Considerations
- The appropriate sheath size and length depend on the target vessel, access site, and outer diameter of the catheter or device being introduced.
- Confirm compatibility among the introducer, guidewire, catheter, embolic device, and any contrast-injection system before use.
- Use fluoroscopic or other appropriate imaging guidance and follow standard sterile vascular-access technique.
- A hemostatic valve can reduce blood loss but does not eliminate bleeding, thrombosis, infection, vessel injury, or air-embolism risk.
- MRI safety should be verified in the current Medcomp instructions for use; do not assume the device is MR Safe or MR Conditional from the FDA clearance alone.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for valved tearway introducer?
The device is indicated for use in procedures requiring vascular access, such as embolization-coil applications.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access with minimal blood loss and successful use in complex procedures.
What complications have been reported?
Safety data indicate potential risks of vascular injury and thrombosis, although these are minimized by the device's design.
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.