đź“Š Evidence-Based Reference
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Aln S.A.R.L.
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 use in cases where anticoagulation is contraindicated or ineffective.
FDA Clearance Information
Pathway
510K
Number
K241507 ↗
Decision Date
June 26, 2024
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 June 26, 2024. It is manufactured by Aln S.A.R.L. and classified as a Class 2 medical device.
What It Is
The ALN Optional Vena Cava Filter is a retrievable device designed to prevent pulmonary embolism by capturing emboli in the inferior vena cava. It is intended for use in patients at risk of venous thromboembolism, particularly when anticoagulation therapy is not suitable.
Clinical Applications
Commonly used in patients with contraindications to anticoagulation or those who have experienced recurrent thromboembolic events despite anticoagulation. It is also used in perioperative settings where temporary protection from emboli is needed.
Evidence Summary
The literature includes 12 studies ranging from retrospective analyses to multicenter registries, covering a period from 2016 to 2025. These studies provide insights into the device's efficacy, safety, and retrieval challenges.
Reported Outcomes
Published studies report that the ALN Optional Vena Cava Filter effectively reduces the incidence of pulmonary embolism in patients with contraindications to anticoagulation. The device has been shown to be retrievable in a significant number of cases, with varying success rates depending on the duration of implantation.
Safety Profile
Reported complications include device tilt, duodenal perforation, and challenges in retrieval, particularly when the filter is embedded. However, the use of advanced retrieval techniques, such as endobronchial forceps, has been documented to improve retrieval success.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and the lack of large-scale randomized controlled trials. Further research is needed to better understand long-term outcomes and optimize retrieval techniques.
Frequently Asked Questions
What are the clinical indications for ALN Optional Vena Cava Filter?
The device is indicated for patients at risk of pulmonary embolism, particularly when anticoagulation is contraindicated or ineffective.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism and successful retrieval in many cases, though outcomes vary based on implantation duration.
What complications have been reported?
Safety data indicate complications such as device tilt, duodenal perforation, and retrieval challenges, especially with embedded filters.
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.