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
Product: ALN Straight RS — all models and sizes
FDA Clearance Information
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
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
Reported Outcomes
Safety Profile
Evidence Limitations
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.