đź“Š Evidence-Based Reference
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
510K
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.
Clinical Applications
Commonly used in patients at high risk of venous thromboembolism, particularly those who cannot undergo anticoagulation therapy. It is often employed in trauma, surgical, or immobilized patients.
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.
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.