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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 510K
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.
Clinical Applications
Commonly used in patients with deep vein thrombosis (DVT) or those at high risk for pulmonary embolism. It is particularly useful in scenarios where anticoagulation is not possible or effective.
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.
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.