đź“Š Evidence-Based Reference
aln optional vena cava filter - femoral approach aln optional vena cava filter - jugular approach aln optional vena cava filter - brachial approach aln optional vena cava filter - femoral approach with hook
Aln Implants Chirurgicaux
Summary: The ALN Optional Vena Cava Filter is a device used to prevent pulmonary embolism by capturing blood clots. It is primarily used when anticoagulation is contraindicated. Key evidence highlights its retrieval challenges and safety profile.
FDA Clearance Information
Pathway 510K
Number K163699 ↗
Decision Date September 8, 2017
Product Code DTK
Device Class Class 2
Evidence 0 studies
The ALN Optional Vena Cava Filter, manufactured by Aln Implants Chirurgicaux, was cleared by the FDA via the 510(k) pathway on September 8, 2017. It is 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 blood clots in the inferior vena cava. It can be inserted via femoral, jugular, or brachial approaches and is intended for temporary or permanent use.
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 of venous thromboembolism.
Evidence Summary
The available literature includes 12 studies, comprising retrospective analyses, registries, and case series, conducted between 2016 and 2025. These studies explore the device's safety, retrieval challenges, and clinical outcomes.
Reported Outcomes
Published studies report that the ALN Optional Vena Cava Filter effectively prevents pulmonary embolism in patients with contraindications to anticoagulation. The device's retrieval success varies, with some studies highlighting challenges due to filter tilt.
Safety Profile
Reported complications include duodenal perforation and challenges in retrieval due to filter tilt. The safety profile is generally favorable, but close monitoring is recommended to mitigate risks.
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 filter is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy or where anticoagulation has failed.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism, with variable success in filter retrieval due to tilt issues.
What complications have been reported?
Reported complications include duodenal perforation and retrieval challenges due to filter tilt.
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.