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enabler-p support catheter
Endocross
Summary: The Enabler-P Support Catheter is a medical device used to assist in the placement and support of venous stents, primarily by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K082339 ↗
Decision Date
November 20, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Enabler-P Support Catheter was cleared via the FDA 510(k) pathway on November 20, 2008. Manufactured by Endocross, it is a Class 2 device under product code DQY.
What It Is
The Enabler-P Support Catheter is a specialized catheter designed to facilitate the placement and support of stents in venous systems. It is used to navigate through occluded or narrowed vessels, providing a stable platform for stent delivery. The catheter's design allows for enhanced maneuverability and support during complex vascular procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly in procedures involving venous stenting. It is suitable for patients with venous occlusions or stenoses, often seen in conditions like deep vein thrombosis or chronic venous insufficiency. The catheter aids in accessing difficult-to-reach lesions and provides support for stent deployment in peripheral vascular interventions.
Indications for Use
The Enabler-P Support Catheter is indicated for use in patients requiring venous stenting, particularly those with occluded or narrowed peripheral veins. It is designed to assist in the delivery and support of stents in these challenging vascular environments.
Practical Considerations
The Enabler-P Support Catheter is typically available in various sizes to accommodate different vessel diameters and anatomical challenges. It is compatible with standard guidewires and stent systems, and clinicians should be familiar with catheter manipulation techniques to optimize its use.
Related Literature
The Accessing Peripheral Occluded LesiOns II (APOLO-II) study investigated the use of the Enabler-P Support Catheter in accessing and treating peripheral occlusions. While specific details and findings are not available, the study likely focused on the catheter's efficacy and safety in clinical settings. Limitations may include the lack of detailed outcomes and patient demographics.
Frequently Asked Questions
What is the Enabler-P Support Catheter used for?
It is used to assist in the placement and support of venous stents, particularly in occluded or narrowed vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device during venous stenting procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring venous stenting, especially in cases of occluded or narrowed peripheral veins.
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.