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elox p 45-bp elox p 53-bp elox p 60-bp
Biotronik
Summary: The elox p series by Biotronik are inferior vena cava (IVC) filters used to prevent pulmonary embolism in patients with contraindications to anticoagulation. Typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K023205 ↗
Decision Date
April 24, 2003
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The elox p 45-bp, 53-bp, and 60-bp devices by Biotronik were cleared through the FDA 510(k) pathway on April 24, 2003. These devices are classified as Class III under product code DTB.
What It Is
The elox p series are IVC filters designed to capture blood clots that may travel from the lower extremities to the lungs, thereby preventing pulmonary embolism. These devices are implanted in the inferior vena cava, the large vein that carries deoxygenated blood from the lower body to the heart. The filters are typically made of metal and are designed to trap clots while allowing normal blood flow.
Clinical Applications
IVC filters like the elox p series are commonly used in patients who have a high risk of developing pulmonary embolism but cannot take anticoagulant medications. This includes patients with active bleeding, recent surgery, or those who have had complications with anticoagulants. They are often placed in a hospital setting by interventional radiologists or vascular surgeons.
Indications for Use
The elox p series is indicated for patients at risk of pulmonary embolism who cannot be treated with anticoagulants. This includes those with contraindications to anticoagulation therapy or who have experienced complications from such treatments.
Practical Considerations
When considering the elox p series, clinicians should be aware of the different sizes available (45-bp, 53-bp, 60-bp) to accommodate varying patient anatomies. Proper imaging and sizing are crucial for successful placement. Compatibility with other vascular access devices should also be considered.
Frequently Asked Questions
What is elox p 45-bp/53-bp/60-bp used for?
The elox p series are IVC filters used to prevent pulmonary embolism in patients who cannot take anticoagulants.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use IVC filters like the elox p series.
What are the FDA-cleared indications?
The devices are indicated for preventing pulmonary embolism in patients who cannot be treated with anticoagulants due to contraindications or complications.
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.