📋 FDA Reference
Elox 45-bp Model 330 132 Efh-27 Model 331 549 Extension Tool Model 331 668
Summary: The elox 45-bp by Biotronik is a medical device used as an inferior vena cava (IVC) filter. It is designed to prevent pulmonary embolism by capturing blood clots. Typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K001413 ↗
Decision Date ?
June 2, 2000
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The elox 45-bp was cleared through the FDA 510(k) pathway on June 2, 2000. Manufactured by Biotronik, it is classified as a Class III device under product code DTB.
What It Is
The elox 45-bp is an inferior vena cava (IVC) filter, a small, cage-like device inserted into the IVC to capture blood clots and prevent them from reaching the lungs, thereby reducing the risk of pulmonary embolism. It is typically deployed via a minimally invasive procedure using a catheter inserted through a vein in the groin or neck. The device is designed to be either permanent or retrievable, depending on patient needs.
FDA-Cleared Indications
- Prevention of recurrent pulmonary embolism when anticoagulation is contraindicated.
- Prevention of recurrent pulmonary embolism when anticoagulation has failed.
- Temporary protection from pulmonary embolism in patients at high risk when anticoagulation is contraindicated or ineffective.
Clinical Applications
- Placement of an IVC filter in the inferior vena cava to reduce the risk of pulmonary embolism.
- Use in patients with venous thromboembolism who cannot receive anticoagulant medication.
- Use when pulmonary embolism has occurred despite appropriate anticoagulation.
- Temporary vena cava filtration when short-term protection is needed and the device is intended for later management according to its labeling and clinical plan.
Reported off-label uses
- Pulmonary embolism prevention in selected patients with a high risk of embolization who do not meet the labeled indications, such as some trauma or perioperative patients.
- Use for prevention of pulmonary embolism in selected patients with limited cardiopulmonary reserve when anticoagulation is not suitable.
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.
Practical Considerations
- Confirm the filter size is compatible with the patient's IVC diameter and anatomy before deployment.
- Placement is generally performed through venous access in the groin or neck using fluoroscopic or other appropriate imaging guidance.
- Review the product labeling and institutional protocol for deployment, extension-tool use, and any retrieval or follow-up requirements; filter permanence or retrievability should not be assumed without confirming the specific labeling.
- Assess for contraindications to venous access, contrast administration, or the procedure, including access-site infection, significant bleeding risk, or unsuitable IVC anatomy.
- MRI safety and conditional scanning requirements must be verified from the current Biotronik labeling; do not assume the filter is safe for all MRI conditions.
Procedures that use this device
Frequently Asked Questions
What is elox 45-bp used for?
The elox 45-bp is used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for preventing recurrent pulmonary embolism in patients with contraindications to anticoagulation or in high-risk situations.
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.