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innerdyne radially expanding vascular access system revas
Innerdyne
Summary: The Innerdyne Radially Expanding Vascular Access System (REVAS) is a medical device used to provide vascular access. It is primarily used by interventional radiologists and surgeons for procedures requiring reliable vascular entry.
FDA Clearance Information
Pathway
510K
Number
K992668 ↗
Decision Date
May 26, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on May 26, 2000. 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 provide a stable and reliable means of vascular access. It utilizes a radial expansion mechanism to minimize trauma to the vessel wall during insertion. This system is particularly useful in procedures requiring repeated or prolonged vascular access, offering a less invasive alternative to traditional methods.
Clinical Applications
This device is commonly used in interventional radiology and surgical settings for procedures such as embolization, catheterization, and other interventions requiring vascular access. It is suitable for use in both adult and pediatric populations, particularly in cases where minimizing vascular trauma is a priority. The device is also beneficial in prenatal procedures, as indicated by its use in fetoscopic access systems.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access, such as embolization. It is designed to facilitate entry into the vascular system with minimal trauma, making it suitable for a variety of clinical scenarios.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters. It is compatible with standard vascular catheters and can be used with the Seldinger technique. Clinicians should be familiar with radial expansion mechanisms to optimize the use of this device.
Related Literature
The linked study explored the development of a percutaneous fetoscopic access system for tracheal occlusion in cases of congenital diaphragmatic hernia. It demonstrated the feasibility of using a radial expansion sheath for safe and effective access to the amniotic cavity. While the study was conducted in an ovine model, it highlighted the potential for reducing maternal morbidity in fetal surgeries. However, further research is needed to validate these findings in human subjects.
Frequently Asked Questions
What is the Innerdyne Radially Expanding Vascular Access System used for?
It is used to provide reliable vascular access for procedures such as embolization and catheterization, minimizing vessel trauma.
What specialties typically use this device?
Interventional radiologists and surgeons commonly use this device in both adult and pediatric settings.
What are the FDA-cleared indications?
The device is indicated for procedures requiring vascular access, offering a less invasive entry into the vascular system.
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.