đź“Š Evidence-Based Reference
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 ?
510(k)
Number ?
K093977 ↗
Decision Date ?
April 22, 2010
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Retrieval of dislodged venous stents from the vascular system.
- Percutaneous intravascular retrieval of a dislodged venous stent using catheter-based imaging guidance.
Clinical Applications
- Percutaneous retrieval of a dislodged venous stent.
- Endovascular removal of a venous stent that has migrated from its intended deployment site.
- Image-guided retrieval during interventional radiology or vascular 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.
Practical Considerations
- The device is identified as model FA-88840-XX; the specific size or configuration should be confirmed from the product labeling before use.
- Use requires suitable vascular access, a compatible delivery or retrieval catheter system, and fluoroscopic or other appropriate intravascular imaging guidance.
- The operator should assess the stent location, vessel size, thrombus burden, vessel injury risk, and whether the stent can be safely captured and withdrawn.
- The FDA record and supplied information do not establish MRI safety; MRI compatibility should be confirmed in the current manufacturer labeling.
- Potential complications include vascular injury, bleeding, thrombosis, embolization, incomplete retrieval, and the need for surgery or another endovascular technique.
Procedures that use this device
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.