Synox SX 53-bp SX 60-bp SX 45-jbp SX 53-jbp Models 120 444 119 684 120 438 and 120 143
FDA Clearance Information
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
FDA-Cleared Indications
- Prevention of pulmonary embolism by placement of an inferior vena cava filter.
- Use in patients at risk for pulmonary embolism when anticoagulant therapy is contraindicated or cannot be used.
Clinical Applications
- Placement in the inferior vena cava to reduce the risk that venous thromboemboli will reach the lungs.
- Use when anticoagulation therapy is medically contraindicated.
- Use as part of IVC filter treatment for patients at risk of pulmonary embolism from lower-extremity or pelvic venous thromboembolism.
Reported off-label uses
- Placement in selected patients with recurrent pulmonary embolism or venous thromboembolism despite therapeutic anticoagulation; this use should be evaluated individually and is not a substitute for treating the underlying clot.
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
- The listed models include different filter configurations and sizes; the selected model must be matched to the patient's IVC diameter and anatomy according to the device labeling.
- Placement is typically performed through venous access, commonly the femoral or internal jugular vein, using fluoroscopic or other appropriate imaging guidance.
- The device labeling and current institutional policy should be reviewed for retrieval capability, because the long-term management of an implanted filter depends on its specific design and clinical circumstances.
- MRI safety and imaging conditions should be confirmed from the original manufacturer labeling before MRI. Do not assume that an older filter is MR Safe or MR Conditional without documentation.
- Potential complications include filter migration, malposition, thrombosis or occlusion of the IVC, perforation, fracture, and recurrent venous thromboembolism; anticoagulation remains the preferred treatment when it can be safely given.
Procedures that use this device
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.