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ex 45-bp model 330 132 ex 53-bp model 130 018 ex 60-bp model 330 133
Biotronik
Summary: The ex 45-bp, ex 53-bp, and ex 60-bp models are IVC filters manufactured by Biotronik, used to prevent pulmonary embolism in patients with contraindications to anticoagulation therapy. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K994240 ↗
Decision Date
April 13, 2000
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
These devices were cleared through the FDA 510(k) pathway on April 13, 2000. Manufactured by Biotronik, they are classified as Class III medical devices under product code DTB.
What It Is
These devices are inferior vena cava (IVC) filters designed to prevent blood clots from traveling to the lungs, which can cause a pulmonary embolism. They are typically implanted in the inferior vena cava, the large vein that carries blood from the lower body to the heart. The filters work by catching large clots while allowing normal blood flow, providing a mechanical barrier to emboli.
Clinical Applications
IVC filters are commonly used in patients who have deep vein thrombosis (DVT) and are at high risk for pulmonary embolism but cannot tolerate anticoagulation therapy. They are often used in emergency settings or when anticoagulation is contraindicated due to bleeding risks. Interventional radiologists and vascular surgeons typically perform the implantation procedure in a hospital setting.
Indications for Use
These devices are indicated for use in patients at risk for pulmonary embolism, particularly when anticoagulation therapy is not suitable. This includes patients with contraindications to anticoagulants or those who have experienced complications from anticoagulation.
Practical Considerations
The sizing of the IVC filter should be chosen based on the patient's anatomy, typically assessed via imaging. Compatibility with the patient's IVC diameter is crucial for effective deployment. The procedure requires fluoroscopic guidance to ensure accurate placement.
Frequently Asked Questions
What is ex 45-bp, ex 53-bp, ex 60-bp used for?
These devices are used to prevent pulmonary embolism in patients who cannot take anticoagulants.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use these devices.
What are the FDA-cleared indications?
These devices are indicated for preventing pulmonary embolism in patients with contraindications to anticoagulation therapy.
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.