📊 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

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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 ? 510(k)
Number ? K163699 ↗
Decision Date ? September 8, 2017
Product Code ? DTK Filter, Intravascular, Cardiovascular
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.

FDA-Cleared Indications

  • Prevention of pulmonary embolism by trapping thrombi in the inferior vena cava.
  • Use in patients with venous thromboembolism who have a contraindication to anticoagulant therapy.
  • Use when anticoagulant therapy is ineffective or cannot adequately prevent thromboembolism.
  • Temporary or permanent filtration of the inferior vena cava, according to the clinical need and device labeling.

Clinical Applications

  • Inferior vena cava filter placement for patients with acute or recurrent venous thromboembolism who cannot receive anticoagulation.
  • Pulmonary embolism prevention when anticoagulation is contraindicated or has not provided adequate protection.
  • Placement through the femoral, internal jugular, or brachial venous approach.
  • Optional filter placement when later retrieval may be clinically appropriate.
  • Permanent inferior vena cava filtration when the filter is not retrieved.

Reported off-label uses

  • Pulmonary embolism prevention in selected patients considered to have very high thromboembolic risk despite being able to receive anticoagulation.
  • Use as an adjunct during selected high-risk venous or orthopedic procedures when clinicians judge embolic risk to be unusually high.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

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.

Practical Considerations

  • The filter is available in configurations for femoral, jugular, and brachial access; the femoral-approach version may include a hook.
  • The treating physician must confirm vessel size, access-vessel suitability, and compatibility with the delivery system before placement.
  • Filter retrieval should be considered when protection is no longer needed, because prolonged dwell time can make retrieval more difficult and may increase device-related complications.
  • MRI safety and conditions depend on the current device labeling and the exact implanted configuration; confirm the manufacturer’s MRI instructions before scanning.
  • The device is not a replacement for anticoagulation when anticoagulation is safe and clinically indicated. Placement requires assessment of bleeding risk, clot burden, caval anatomy, and potential contraindications.

Procedures that use this device

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.

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