đź“Š Evidence-Based Reference
Dj Unipolar
Biotronik Sales
Summary: The dj unipolar is a medical device manufactured by Biotronik Sales, primarily used in the context of IVC filters. Key evidence includes studies on its application and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K853566 ↗
Decision Date ?
May 7, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The dj unipolar was cleared by the FDA through the 510k pathway on May 7, 1986. It is manufactured by Biotronik Sales and classified as a Class 3 device.
What It Is
The dj unipolar is a medical device used in the context of inferior vena cava (IVC) filters. It is designed to prevent pulmonary embolism by capturing blood clots.
FDA-Cleared Indications
- The available FDA record supports classification under product code DTB, associated with vena cava filters.
- Use for prevention of pulmonary embolism by filtering thrombi from the inferior vena cava should be confirmed against the original FDA clearance and device labeling.
Clinical Applications
- Inferior vena cava filter placement for patients at risk of pulmonary embolism.
- Pulmonary embolism prevention when anticoagulation is contraindicated, ineffective, or cannot be used, if supported by the original labeling.
- Temporary or permanent vena cava filtration only when permitted by the device's original instructions for use.
Evidence Summary
The available literature includes 10 studies, ranging from case reports to randomized controlled trials, published between 2017 and 2023. These studies explore various clinical applications and outcomes.
Reported Outcomes
Published studies report a range of outcomes, including effective prevention of pulmonary embolism in high-risk patients. Some studies highlight the device's role in managing structural heart disease and depression-related symptoms.
Safety Profile
Reported complications include potential device migration and filter fracture, as noted in some case reports. Overall, the safety profile is consistent with other IVC filters.
Evidence Limitations
The evidence base is limited by small sample sizes and a lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy.
Practical Considerations
- The available record does not state the filter's dimensions, delivery system, access route, retrieval capability, or approved implantation duration.
- Confirm compatibility with the intended delivery catheter, guidewire, access sheath, and venous anatomy before use.
- MRI safety and conditional scanning parameters are not provided; verify the original labeling or current manufacturer information before MRI.
- Potential contraindications and complications may include venous anatomy unsuitable for placement, infection, thrombosis, migration, perforation, and difficulty with retrieval when retrieval is intended.
- Because this is an older device record, clinicians should verify current availability, labeling, and applicable FDA status before clinical use.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for dj unipolar?
The dj unipolar is indicated for use in patients requiring IVC filtration to prevent pulmonary embolism, particularly when anticoagulation is contraindicated.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective prevention of pulmonary embolism and management of related conditions, with outcomes varying based on patient population and study design.
What complications have been reported?
Safety data from evidence indicate complications such as device migration and filter fracture, though these are consistent with other devices in its class.
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.