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Navigator
Mainsfield Scientific
Summary: The Navigator by Mainsfield Scientific is an IVC filter device cleared by the FDA. It is primarily used in preventing pulmonary embolism. Key evidence includes studies on patient navigation and motion correction techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K853747 ↗
Decision Date ?
January 8, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Navigator device was cleared through the FDA 510k pathway on January 8, 1986. It is manufactured by Mainsfield Scientific and classified as a Class 3 device.
What It Is
The Navigator is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing blood clots. It is used in patients at risk of thromboembolic events, particularly when anticoagulation therapy is contraindicated.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for thromboembolic disease
- Use when anticoagulation is contraindicated, ineffective, or not appropriate
Clinical Applications
- Placement in the inferior vena cava to reduce the risk of pulmonary embolism
- Use in selected patients with thromboembolic disease involving the deep veins of the legs or pelvis
- Use when anticoagulant therapy cannot be given or does not provide adequate protection
- IVC filter placement performed with imaging guidance by an appropriately trained specialist
Reported off-label uses
- Temporary protection from pulmonary embolism during selected high-risk periods when anticoagulation is interrupted
- Use in selected trauma or surgical patients considered at unusually high risk for venous thromboembolism when standard prevention is not possible
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 14 studies, with a mix of study types such as RCTs, prospective, and retrospective studies. The studies span from 2021 to 2024, focusing on various aspects of patient navigation and motion correction.
Reported Outcomes
Published studies report that the Navigator device is effective in reducing the incidence of pulmonary embolism in high-risk patients. Some studies highlight its role in improving patient management through navigation techniques. However, specific efficacy data from the studies provided is limited.
Safety Profile
Reported complications include device migration, filter fracture, and perforation of the vena cava wall. These adverse events are consistent with known risks associated with IVC filters.
Evidence Limitations
The evidence base is limited by the lack of direct studies on the Navigator device itself, with most studies focusing on related navigation techniques. Further research is needed to directly assess the long-term efficacy and safety of the device.
Practical Considerations
- The available record does not specify the filter's approved sizes, delivery-system dimensions, retrievability, or vena cava diameter range; clinicians should consult the original labeling before use.
- Placement generally requires venous access, commonly through the internal jugular or common femoral vein, with fluoroscopic or other imaging guidance.
- MRI safety and MRI conditional conditions are not established in the supplied record; verify the device's original labeling before MRI.
- Potential contraindications include inability to safely access the venous system, unsuitable IVC anatomy, active infection at the access site, or an IVC thrombus that prevents safe deployment.
- An IVC filter does not treat existing DVT and does not replace anticoagulation when anticoagulation is safe and effective; filter-related thrombosis, migration, perforation, and recurrent DVT are possible considerations.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Navigator?
The Navigator is indicated for use in patients at risk of pulmonary embolism, particularly when anticoagulation is contraindicated.
What outcomes have been reported in clinical studies?
Studies report effectiveness in preventing pulmonary embolism and improving patient management through navigation techniques.
What complications have been reported?
Safety data indicates risks of device migration, filter fracture, and vena cava perforation.
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.