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Biotronik
Summary: The Synox SX models by Biotronik are FDA-cleared inferior vena cava (IVC) filters used to prevent pulmonary embolism. They are typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K980869 ↗
Decision Date
September 10, 1998
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Synox SX models were cleared through the FDA 510(k) pathway on September 10, 1998. Manufactured by Biotronik, these devices are classified as Class III under product code DTB.
What It Is
The Synox SX models are a series of inferior vena cava (IVC) filters designed to prevent blood clots from traveling to the lungs, thereby reducing the risk of pulmonary embolism. These devices are implanted into the inferior vena cava, a large vein carrying deoxygenated blood from the lower body to the heart. The filter captures clots while allowing normal blood flow, offering a protective measure for patients at risk of thromboembolic events.
Clinical Applications
IVC filters like the Synox SX models are commonly used in patients who have contraindications to anticoagulation therapy or have experienced recurrent venous thromboembolism despite anticoagulation. They are often placed in settings such as interventional radiology suites or operating rooms. Typical patient populations include those with deep vein thrombosis, trauma patients, or those undergoing high-risk surgeries.
Indications for Use
The FDA indications for the Synox SX models include preventing pulmonary embolism in patients who cannot undergo anticoagulation therapy. They are suitable for individuals with a history of venous thromboembolism or those at high risk for clot formation.
Practical Considerations
When considering the Synox SX models, clinicians should be aware of the sizing options to ensure proper fit within the patient's inferior vena cava. Compatibility with imaging techniques for placement and potential retrieval should also be considered. Proper technique during insertion is crucial to minimize complications.
Frequently Asked Questions
What is Synox SX used for?
The Synox SX models are used as inferior vena cava filters to prevent pulmonary embolism in patients at risk of thromboembolic events.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use IVC filters like the Synox SX models.
What are the FDA-cleared indications?
The FDA-cleared indications include preventing pulmonary embolism in patients who cannot receive anticoagulation therapy or have recurrent venous thromboembolism.
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.