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innerdyne radially expanding vascular access system
Innerdyne
Summary: The Innerdyne Radially Expanding Vascular Access System is a medical device used to gain vascular access during procedures such as embolization. It is typically used by interventional radiologists and surgeons.
FDA Clearance Information
Pathway
510K
Number
K972684 ↗
Decision Date
October 10, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on October 10, 1997. Manufactured by Innerdyne, it is classified as a Class 2 device under product code DYB.
What It Is
The Innerdyne Radially Expanding Vascular Access System is designed to facilitate vascular access by expanding radially to create a stable entry point. This system minimizes trauma to the vessel wall and provides a reliable conduit for the insertion of catheters or other devices. Its radial expansion mechanism is particularly useful in reducing complications associated with traditional access methods.
Clinical Applications
This device is commonly used in interventional radiology and surgical procedures that require vascular access, such as embolization. It is particularly beneficial in settings where minimizing vessel trauma is crucial, such as in pediatric or high-risk patients. The system is also used in prenatal procedures, as demonstrated in the linked study, to access the amniotic cavity safely.
Indications for Use
The device is indicated for use in procedures requiring vascular access, particularly those involving the insertion of embolization coils. It is suitable for patients needing interventions that require stable and minimally invasive vascular entry.
Practical Considerations
The device is typically available in various sizes to accommodate different vessel diameters. It is compatible with standard vascular catheters and requires familiarity with the Seldinger technique for optimal use. Clinicians should ensure proper sizing and technique to minimize complications.
Related Literature
The linked study explored the development of a percutaneous fetoscopic access system for tracheal occlusion in congenital diaphragmatic hernia. It demonstrated the feasibility of using a radially expanding sheath for safe access in an ovine model, highlighting its potential to reduce maternal morbidity. However, the study was limited to an animal model, and further research is needed to confirm its applicability in humans.
Frequently Asked Questions
What is the Innerdyne Radially Expanding Vascular Access System used for?
It is used to gain vascular access during procedures like embolization, reducing vessel trauma.
What specialties typically use this device?
Interventional radiologists and surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for procedures requiring vascular access, such as the insertion of embolization coils.
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.