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medtronic model 6958
Medtronic Vascular
Summary: The Medtronic Model 6958 is an IVC filter used to prevent pulmonary embolism. It is FDA-cleared and supported by two studies, focusing on stroke-related imaging outcomes.
FDA Clearance Information
Pathway
510K
Number
K800870 ↗
Decision Date
November 13, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 6958 was cleared through the FDA 510(k) pathway on November 13, 1980. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 6958 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 for pulmonary embolism, particularly those who cannot undergo anticoagulation therapy. It is often employed in trauma patients, those with deep vein thrombosis, or during surgical procedures.
Evidence Summary
The available literature includes two studies published between 2023 and 2025. These studies focus on imaging outcomes related to ischemic stroke, utilizing methodologies such as RCTs and prospective analyses.
Reported Outcomes
Published studies report on the association between blood-brain barrier leakage and infarction in ischemic stroke, as well as the reversibility of diffusion-weighted imaging lesions. These findings highlight the device's role in managing stroke-related complications.
Safety Profile
Reported complications include potential adverse events related to the placement and function of the IVC filter, although specific safety data from the provided studies are not detailed.
Evidence Limitations
The evidence is limited by its focus on stroke-related imaging outcomes rather than direct IVC filter efficacy. Further research is needed to evaluate long-term safety and effectiveness in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 6958?
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 report on imaging outcomes in ischemic stroke, such as blood-brain barrier leakage and DWI lesion reversibility.
What complications have been reported?
Reported complications include general adverse events related to IVC filter placement, though specific data from the studies are not detailed.
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.