đź“Š Evidence-Based Reference
medtronic model 6972
Medtronic Vascular
Summary: The Medtronic Model 6972 is an IVC filter used to prevent pulmonary embolism. It is FDA 510k cleared and linked to studies reporting on its safety and efficacy.
FDA Clearance Information
Pathway 510K
Number K790462 ↗
Decision Date April 16, 1979
Product Code DTB
Device Class Class 3
Evidence 0 studies
The Medtronic Model 6972 was cleared through the FDA 510k pathway on April 16, 1979. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Medtronic Model 6972 is an inferior vena cava (IVC) filter designed 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 with contraindications to anticoagulation therapy or those with recurrent venous thromboembolism despite anticoagulation. It provides a mechanical barrier to emboli traveling to the lungs.
Evidence Summary
The available literature includes 7 studies, encompassing various study types such as retrospective and prospective analyses. The studies range from 1991 to 2025, providing insights into the device's performance over time.
Reported Outcomes
Published studies report varying outcomes for the Medtronic Model 6972. One study noted a complication rate of 26.3% for this model, indicating a need for careful patient selection and monitoring. Long-term performance data suggest differences in failure rates based on insulation type.
Safety Profile
Reported complications include a 26.3% complication rate for the Medtronic Model 6972, as noted in a study comparing different lead models. Safety profiles vary, highlighting the importance of considering individual patient factors.
Evidence Limitations
The evidence is limited by the variability in study designs and the age of some studies, which may not reflect current clinical practices. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 6972?
The device is indicated for use in patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report a complication rate of 26.3% and highlight differences in performance based on lead insulation type.
What complications have been reported?
Safety data indicate a 26.3% complication rate, with variations based on specific device models and patient factors.
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.