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medtronic temptron
Medtronic Vascular
Summary: The Medtronic Temptron is an IVC filter device used primarily for preventing pulmonary embolism. Key evidence includes studies on its efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K790261 ↗
Decision Date
February 27, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Temptron was cleared via the FDA 510k pathway on February 27, 1979. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Medtronic Temptron 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
The device is commonly used in patients who are at high risk for pulmonary embolism, particularly when anticoagulation therapy is contraindicated or ineffective.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, published between 2024 and 2025.
Reported Outcomes
Published studies report that the Medtronic Temptron effectively reduces the incidence of pulmonary embolism in high-risk patients. The device has shown efficacy in capturing emboli and preventing their migration to the lungs.
Safety Profile
Reported complications include device migration, filter fracture, and thrombosis at the insertion site. These events are relatively rare but should be monitored.
Evidence Limitations
Current evidence is limited by the lack of long-term follow-up data and small sample sizes in some studies. Further research is needed to assess long-term safety and efficacy.
Frequently Asked Questions
What are the clinical indications for Medtronic Temptron?
The Medtronic Temptron is indicated for patients at risk of pulmonary embolism, especially when anticoagulation is not an option.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in pulmonary embolism incidence and effective emboli capture.
What complications have been reported?
Safety data indicate potential complications such as device migration, filter fracture, and thrombosis.
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.