đź“Š Evidence-Based Reference
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Aln Implants Chirurgicaux
Summary: The ALN Optional Vena Cava Filter is a device used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence highlights its retrieval challenges and safety profile.
FDA Clearance Information
Pathway
510K
Number
K070514 ↗
Decision Date
January 30, 2008
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The ALN Optional Vena Cava Filter was cleared through the FDA 510(k) pathway on January 30, 2008. It is manufactured by Aln Implants Chirurgicaux and classified as a Class II device.
What It Is
The ALN Optional Vena Cava Filter is a medical device designed to prevent pulmonary embolism by capturing thrombi in the inferior vena cava. It is intended for temporary or permanent implantation, with options for retrieval.
Clinical Applications
This device is commonly used in patients who have contraindications to anticoagulation therapy or in cases where anticoagulation has failed. It is also used in patients at high risk for venous thromboembolism.
Evidence Summary
The literature includes 10 studies ranging from retrospective analyses to multicenter registries, published between 2016 and 2025. These studies explore the device's safety, retrieval success, and complication rates.
Reported Outcomes
Published studies report varying success rates in the retrieval of the ALN Optional Vena Cava Filter, with challenges noted in cases of filter tilt and embedment. The device has been effective in preventing pulmonary embolism in patients with contraindications to anticoagulation.
Safety Profile
Reported complications include duodenal perforation and challenges in retrieval due to filter embedment. The safety profile is generally favorable, but close monitoring is recommended.
Evidence Limitations
Evidence gaps include limited long-term follow-up data and a need for more randomized controlled trials to better assess the comparative effectiveness of the device. Further research is needed to optimize retrieval techniques.
Frequently Asked Questions
What are the clinical indications for ALN Optional Vena Cava Filter?
The device is indicated for patients with contraindications to anticoagulation therapy or those who have experienced failure of anticoagulation, as well as for prophylactic use in high-risk patients.
What outcomes have been reported in clinical studies?
Studies have reported successful prevention of pulmonary embolism and challenges in retrieval due to filter tilt and embedment.
What complications have been reported?
Safety data indicate complications such as duodenal perforation and difficulties in retrieval due to embedment of the filter.
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.