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alligator-hd retrieval device ard-hd model fa-88840-xx
Chestnut Medical Technologies
Summary: The Alligator-HD Retrieval Device by Chestnut Medical Technologies is designed for retrieving dislodged venous stents. Key evidence highlights its efficacy in retrieval scenarios.
FDA Clearance Information
Pathway
510K
Number
K093977 ↗
Decision Date
April 22, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Alligator-HD Retrieval Device was cleared by the FDA via the 510(k) pathway on April 22, 2010. It is manufactured by Chestnut Medical Technologies and classified as a Class 2 device.
What It Is
The Alligator-HD Retrieval Device is a medical tool used to retrieve dislodged venous stents. It operates by capturing and securing the stent for removal, ensuring safe retrieval in clinical settings.
Clinical Applications
This device is commonly used in scenarios where venous stents have become dislodged and require retrieval. It is particularly useful in interventional radiology and cardiology procedures.
Evidence Summary
The available literature includes 10 studies, encompassing randomized controlled trials and other study types, published between 2021 and 2023. These studies explore various retrieval techniques and device performance.
Reported Outcomes
Published studies report that the Alligator-HD Retrieval Device is effective in retrieving dislodged stents, with high capture force and retrieval rates. The small-balloon technique has been specifically highlighted for its efficacy in proximal and distal stent capture.
Safety Profile
Reported complications include potential challenges in retrieval force application and device handling. However, no significant adverse events have been consistently documented across studies.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for more diverse clinical scenarios. Further research is needed to explore long-term outcomes and device performance in varied patient populations.
Frequently Asked Questions
What are the clinical indications for Alligator-HD Retrieval Device?
The device is indicated for the retrieval of dislodged venous stents, particularly in interventional radiology and cardiology.
What outcomes have been reported in clinical studies?
Studies report high efficacy in stent retrieval, with successful capture and removal rates using the device.
What complications have been reported?
Reported complications include challenges in retrieval force application, but significant adverse events are not consistently documented.
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.