đź“‹ FDA Reference
alligator retrieval device ard
Chestnut Medical Technologies
Summary: The Alligator Retrieval Device (ARD) is used in endovascular procedures to retrieve or reposition devices within blood vessels. It is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway 510K
Number K043580 ↗
Decision Date March 24, 2005
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Alligator Retrieval Device ARD was cleared via the FDA 510(k) pathway on March 24, 2005. It is manufactured by Chestnut Medical Technologies and is classified as a Class 2 device under product code DQY.
What It Is
The Alligator Retrieval Device is a specialized tool designed for retrieving or repositioning devices within the vascular system. It features a flexible, maneuverable design that allows clinicians to navigate through blood vessels to capture and remove foreign objects or misplaced stents. This device is particularly useful in complex endovascular procedures where precision and control are crucial.
Clinical Applications
The ARD is commonly used in interventional radiology and neurosurgery, particularly in procedures involving the retrieval of misplaced or deformed stents within the intracranial or peripheral vasculature. It is also used in cases where foreign bodies need to be extracted from the venous system. The device is suitable for use in hospital settings, especially in specialized centers dealing with complex vascular interventions.
Indications for Use
The FDA-cleared indications for the ARD involve its use in retrieving or repositioning devices within the vascular system. This includes situations where stents or other endovascular devices have been inadvertently displaced or deformed, posing a risk of obstruction or thromboembolic events.
Practical Considerations
The ARD is typically available in various sizes to accommodate different vessel diameters. It is compatible with standard endovascular equipment and requires careful handling to ensure successful retrieval without causing vessel damage. Clinicians should be familiar with the device's operation and integration into existing procedural workflows.
Related Literature
The linked study discusses the use of the Alligator Retrieval Device in two cases where intracranial stents were inadvertently deformed and displaced. The ARD was successfully used to reposition the stents, preventing potential complications such as thromboembolic events. The study highlights the device's utility in complex endovascular procedures but is limited by its small sample size and focus on specific cases.
Frequently Asked Questions
What is the Alligator Retrieval Device ARD used for?
The ARD is used to retrieve or reposition devices, such as stents, within the vascular system, particularly when they have been displaced or deformed.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use the ARD in endovascular procedures.
What are the FDA-cleared indications?
The ARD is indicated for retrieving or repositioning devices within the vascular system, especially in cases of displaced or deformed stents.
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.