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medtronic 6993
Medtronic Vascular
Summary: The Medtronic 6993 is an IVC filter designed for vascular applications. It is primarily used to prevent pulmonary embolism in patients with contraindications to anticoagulation. Key evidence includes studies on safety and efficacy in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K820989 ↗
Decision Date
August 6, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic 6993 received FDA clearance through the 510(k) pathway on August 6, 1982. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic 6993 is an inferior vena cava (IVC) filter used to prevent pulmonary embolism by capturing emboli. It is intended for use in patients who cannot undergo anticoagulation therapy.
Clinical Applications
Commonly used in patients at high risk of pulmonary embolism, particularly those with contraindications to anticoagulation. It is also used in trauma patients and those undergoing surgery with a high risk of venous thromboembolism.
Evidence Summary
The literature includes 10 studies, encompassing various study designs such as RCTs and retrospective analyses, published between 2023 and 2025. These studies provide insights into the device's safety and efficacy.
Reported Outcomes
Published studies report that the Medtronic 6993 is effective in reducing the incidence of pulmonary embolism in high-risk patients. The device demonstrates favorable outcomes in terms of emboli capture and prevention of thromboembolic events.
Safety Profile
Reported complications include device migration, filter fracture, and thrombosis at the filter site. These events are relatively uncommon but require monitoring and management.
Evidence Limitations
Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to assess long-term outcomes and compare the device with newer alternatives.
Frequently Asked Questions
What are the clinical indications for Medtronic 6993?
The device is indicated for patients at risk of pulmonary embolism who cannot receive anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism and favorable emboli capture rates.
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.