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innerdyne radially expanding vascular access system heparin coated
Innerdyne
Summary: The Innerdyne Radially Expanding Vascular Access System is a heparin-coated device used to provide vascular access, primarily in interventional radiology and surgical procedures. It is utilized by clinicians to facilitate the insertion of catheters or other instruments into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K980578 ↗
Decision Date
September 11, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 11, 1998. Manufactured by Innerdyne, it is classified as a Class 2 medical 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 accessing the vascular system. It features a heparin coating to reduce the risk of thrombosis and improve biocompatibility. The radial expansion mechanism allows for minimal trauma during insertion, making it suitable for delicate vascular procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings to facilitate the insertion of catheters or other instruments. It is particularly useful in procedures requiring precise vascular access, such as embolization or the placement of stents. The device is suitable for adult and pediatric patients, depending on the specific clinical scenario.
Indications for Use
The device is indicated for use in procedures requiring vascular access, such as the insertion of embolization coils. It is suitable for patients needing minimally invasive access to the vascular system, often in the context of interventional radiology or vascular surgery.
Practical Considerations
The device is available in various sizes to accommodate different vascular anatomies. Clinicians should ensure compatibility with other instruments used in the procedure. Proper technique is essential to minimize vascular trauma and ensure successful access.
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 radial expansion sheath for safe access in an ovine model. The study highlighted the potential for reducing maternal morbidity by avoiding laparotomy, though it was limited by its animal model and early-stage development.
Frequently Asked Questions
What is the Innerdyne Radially Expanding Vascular Access System used for?
It is used to provide vascular access for procedures such as catheter insertion and embolization in interventional radiology and vascular surgery.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in procedures requiring precise vascular access.
What are the FDA-cleared indications?
The device is indicated for use in 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.