📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for thromboembolic disease
- Use when anticoagulant therapy is contraindicated or ineffective
Clinical Applications
- Placement in the inferior vena cava to reduce the risk of pulmonary embolism
- Use in patients with venous thromboembolic disease who cannot receive anticoagulation
- Use when pulmonary embolism risk persists despite anticoagulant treatment
Reported off-label uses
- Temporary protection from pulmonary embolism during selected high-risk periods when anticoagulation is interrupted
- Use in selected patients with recurrent pulmonary embolism despite anticoagulation
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The device is an IVC filter and is intended for placement in the inferior vena cava; the available FDA record should be reviewed for the labeled delivery system, dimensions, and deployment requirements.
- Placement is typically performed through venous access, commonly the jugular or femoral vein, using fluoroscopic imaging and contrast venography when appropriate.
- MRI safety and any conditions for scanning should be confirmed in the current device labeling; older filters may not have the same MRI documentation as newer devices.
- Potential complications include filter migration, malposition, thrombosis or occlusion of the IVC, perforation, fracture, and recurrent pulmonary embolism.
- The risks and benefits of filter placement should be weighed against anticoagulation and other treatments; retrieval should not be assumed unless the specific device is labeled and suitable for retrieval.
Procedures that use this device
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.