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Medtronic 4951
Medtronic Vascular
Summary: The Medtronic 4951 is an IVC filter device used to prevent pulmonary embolism. It is FDA-cleared and supported by 10 studies, focusing on its clinical efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K812599 ↗
Decision Date ?
October 23, 1981
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Medtronic 4951 received FDA clearance via the 510(k) pathway on October 23, 1981. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic 4951 is an inferior vena cava (IVC) filter designed to prevent blood clots from traveling to the lungs, thereby reducing the risk of pulmonary embolism. It is intended for use in patients with contraindications to anticoagulation therapy.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for venous thromboembolism.
- Use in patients with contraindications to anticoagulation therapy.
- Interruption of embolic material traveling through the inferior vena cava to the pulmonary arteries.
Clinical Applications
- Placement in the inferior vena cava to reduce the risk of pulmonary embolism.
- Use in patients who cannot receive anticoagulant medication because of bleeding risk or another contraindication.
- Use during care of selected patients at risk for venous thromboembolism when protection from pulmonary embolism is clinically indicated.
Reported off-label uses
- Use in selected patients who develop recurrent pulmonary embolism despite therapeutic anticoagulation.
- Use for temporary protection during certain high-risk periods when anticoagulation must be interrupted.
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.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and observational studies, published between 2024 and 2026. These studies provide insights into the device's clinical performance and safety profile.
Reported Outcomes
Published studies report varied outcomes, with some indicating effective prevention of pulmonary embolism in high-risk patients. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include device migration, filter fracture, and thrombosis at the filter site. The evidence highlights the need for careful patient selection and monitoring.
Evidence Limitations
The evidence lacks detailed quantitative outcomes and long-term follow-up data. Further research is needed to establish comprehensive safety and efficacy profiles, particularly in diverse patient populations.
Practical Considerations
- The device is an older IVC filter, and current availability, delivery system specifications, and approved sizes should be confirmed in the applicable FDA labeling and manufacturer documentation.
- Placement requires imaging guidance, usually through venous access in the neck or groin, with the filter positioned in the inferior vena cava.
- The filter is generally considered a permanent implant unless a specific model and labeling support retrieval; retrieval should not be assumed for this device without confirming the product documentation.
- MRI conditions are device-specific. MRI safety or conditional status should be verified from the manufacturer’s labeling before scanning.
- Contraindications and risks include unsuitable IVC anatomy, active infection at the access site, filter malposition, vena cava thrombosis, migration, fracture, perforation, and recurrent deep vein thrombosis.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Medtronic 4951?
The device is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies suggest effective prevention of pulmonary embolism, though specific efficacy metrics are not detailed.
What complications have been reported?
Safety data indicate risks of device migration, filter fracture, and thrombosis at the filter site.
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.