📊 Evidence-Based Reference
Aln Optional Vena Cava Filter Fb 010500 Ff 010995 Fj 120096 Fb Hook Ff Hook Fj Hook
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 ?
510(k)
Number ?
K241507 ↗
Decision Date ?
June 26, 2024
Product Code ?
DTK Filter, Intravascular, Cardiovascular
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.
FDA-Cleared Indications
- Prevention of pulmonary embolism by trapping emboli in the inferior vena cava.
- Use in patients at risk for venous thromboembolism when anticoagulation is contraindicated.
- Use when anticoagulation is ineffective or cannot provide adequate protection from pulmonary embolism.
Clinical Applications
- Percutaneous placement of a retrievable filter in the inferior vena cava.
- Temporary protection from pulmonary embolism in patients who cannot receive anticoagulant therapy.
- Protection from pulmonary embolism in patients with recurrent thromboembolic events despite anticoagulation.
- Retrieval of the filter when continued filtration is no longer clinically needed and removal is appropriate.
Reported off-label uses
- Use for selected patients with a high risk of pulmonary embolism when anticoagulation is possible but considered insufficient by the treating team.
- Use in selected perioperative or trauma situations for temporary pulmonary embolism protection outside the specific labeled indication.
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 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.
Practical Considerations
- The filter is intended for optional retrieval; the treating clinician should assess whether and when removal is appropriate.
- Placement and retrieval are typically performed through venous access, commonly the jugular or femoral vein, using fluoroscopic imaging.
- The filter must be matched to the patient's inferior vena cava anatomy and the device's labeled vessel-size range; the FDA record supplied here does not specify the available size range.
- Review the current manufacturer instructions for MRI conditions, delivery-system compatibility, and contraindications before imaging or implantation.
- Potential complications include access-site bleeding, filter migration or tilt, caval perforation, thrombosis, fracture, and difficulty with retrieval.
Procedures that use this device
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.