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crux vena cava filter system
Crux Biomedical
Summary: The Crux Vena Cava Filter System is a medical device designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence includes studies evaluating its safety and effectiveness.
FDA Clearance Information
Pathway
510K
Number
K122585 ↗
Decision Date
January 17, 2013
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Crux Vena Cava Filter System was cleared by the FDA through the 510(k) pathway on January 17, 2013. It is manufactured by Crux Biomedical and classified as a Class 2 medical device.
What It Is
The Crux Vena Cava Filter System is a retrievable filter designed to be placed in the inferior vena cava to prevent pulmonary embolism by capturing embolic clots. It is intended for use in patients at risk of venous thromboembolism.
Clinical Applications
This device is commonly used in patients who are at risk of pulmonary embolism and cannot undergo anticoagulation therapy. It is often employed in both prophylactic and therapeutic contexts to prevent clot migration.
Evidence Summary
The available literature includes seven studies, comprising randomized controlled trials and prospective studies, evaluating the safety and effectiveness of the Crux Vena Cava Filter. These studies span from 2013 to 2020.
Reported Outcomes
Published studies report that the Crux Vena Cava Filter is effective in preventing pulmonary embolism in patients at risk. The RETRIEVE trial specifically evaluated its safety and effectiveness, demonstrating positive outcomes in reducing embolic events.
Safety Profile
Reported complications include device migration, filter fracture, and thrombosis at the filter site. However, the studies generally indicate a favorable safety profile for the Crux Vena Cava Filter.
Evidence Limitations
The evidence is limited by the small number of large-scale randomized controlled trials. Further research is needed to evaluate long-term outcomes and compare the Crux Vena Cava Filter with other available filters.
Frequently Asked Questions
What are the clinical indications for Crux Vena Cava Filter System?
The Crux Vena Cava Filter System is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Clinical studies report that the Crux Vena Cava Filter is effective in preventing pulmonary embolism, with positive safety and effectiveness outcomes.
What complications have been reported?
Reported complications include device migration, filter fracture, and thrombosis at the filter site.
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.