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Biotronik
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 510K
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.
Clinical Applications
IVC filters like the elox 45-bp are commonly used in patients who have a high risk of developing pulmonary embolism, particularly when anticoagulation therapy is contraindicated or ineffective. They are often employed in trauma settings, post-surgical patients, or those with a history of deep vein thrombosis (DVT). The device is primarily used by interventional radiologists and vascular surgeons in hospital settings.
Indications for Use
The FDA indications for the elox 45-bp include prevention of recurrent pulmonary embolism in patients with contraindications to anticoagulation, those who have experienced recurrent embolism despite anticoagulation, or those who require temporary protection in high-risk situations.
Practical Considerations
The elox 45-bp is available in various sizes to accommodate different patient anatomies. It is crucial to ensure compatibility with the patient's IVC size and to follow precise deployment techniques to avoid complications. Familiarity with the retrieval process is important if the filter is intended to be temporary.
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.