📊 Evidence-Based Reference
Aln Optional Vena Cava Filter-Femoral Approach Jugular Approach Brachial Approach Extraction Kit Precurved Extractio
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 ?
510(k)
Number ?
K070514 ↗
Decision Date ?
January 30, 2008
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 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.
FDA-Cleared Indications
- Prevention of pulmonary embolism by trapping thrombi in the inferior vena cava.
- Use when anticoagulation therapy is contraindicated or cannot be used.
- Use when anticoagulation therapy has failed or is not effective.
Clinical Applications
- Placement in the inferior vena cava for pulmonary embolism protection.
- Temporary vena cava filtration when anticoagulation is contraindicated.
- Vena cava filtration when anticoagulation has failed.
- Optional retrieval after the period of pulmonary embolism risk has passed, when retrieval is clinically appropriate.
Reported off-label uses
- Use for selected patients with recurrent pulmonary embolism despite anticoagulation, beyond the labeled failure-of-anticoagulation indication.
- Use in selected patients with temporary high thromboembolic risk when standard labeling does not clearly apply.
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 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.
Practical Considerations
- Placement and retrieval require fluoroscopic or other appropriate imaging guidance, typically through femoral, jugular, or brachial venous access.
- The filter is an optional or retrievable device, but retrieval may become difficult or impossible because of filter tilt, tissue incorporation, clot within the filter, migration, or prolonged dwell time.
- Device size and delivery-system compatibility must be confirmed against the patient's inferior vena cava dimensions and the manufacturer's instructions for use.
- MRI conditions and safety depend on the specific device labeling and implant status; verify current manufacturer MRI information before scanning.
- Contraindications and precautions include unsuitable venous anatomy, thrombosis at the intended access or implantation site, infection, and inability to safely perform the procedure.
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 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.