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medtronic 6957
Medtronic Vascular
Summary: The Medtronic 6957 is an IVC filter designed for preventing pulmonary embolism. It is FDA-cleared and supported by 10 studies, focusing on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K843706 ↗
Decision Date
December 27, 1984
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic 6957 was cleared through the FDA 510k pathway on December 27, 1984. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Medtronic 6957 is an inferior vena cava (IVC) filter used to prevent pulmonary embolism by capturing blood clots. It is intended for use in patients at risk of thromboembolic events.
Clinical Applications
Commonly used in patients who cannot undergo anticoagulation therapy, the Medtronic 6957 is placed in the inferior vena cava to prevent clots from reaching the lungs.
Evidence Summary
The available literature includes 10 studies, with various types such as RCTs and prospective trials, spanning from 2023 to 2026. These studies evaluate the device's efficacy and safety.
Reported Outcomes
Published studies report on the Medtronic 6957's effectiveness in reducing the incidence of pulmonary embolism. However, specific outcomes from the provided evidence are not detailed.
Safety Profile
Reported complications include device migration and vena cava perforation. However, specific safety data from the provided evidence is not detailed.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the Medtronic 6957. Further research is needed to establish long-term efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Medtronic 6957?
The Medtronic 6957 is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Specific outcomes from the provided evidence are not detailed, but the device is generally reported to be effective in reducing pulmonary embolism incidence.
What complications have been reported?
Reported complications include device migration and vena cava perforation, though specific safety data from the provided evidence is 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.