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 highlights its safety and effectiveness in patients at risk for venous thromboembolism.
The Crux Vena Cava Filter System was cleared by the FDA through the 510(k) pathway on July 13, 2012. 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 material. It is intended for use in patients at risk for venous thromboembolism who cannot undergo anticoagulation therapy.
Clinical Applications
Common clinical scenarios for the Crux Vena Cava Filter System include patients with contraindications to anticoagulation, those with recurrent venous thromboembolism despite anticoagulation, and individuals undergoing high-risk surgical procedures.
Evidence Summary
The available literature includes a mix of randomized controlled trials, prospective, and retrospective studies, with a total of 7 studies identified. The studies span from 2013 to 2020, focusing on the safety and effectiveness of the device.
Reported Outcomes
Published studies report that the Crux Vena Cava Filter System is effective in preventing pulmonary embolism in patients at risk for venous thromboembolism. The RETRIEVE trial demonstrated its safety and effectiveness, while other studies have supported its use in clinical practice.
Safety Profile
Reported complications include device migration, filter fracture, and thrombosis at the filter site. However, the overall safety profile is considered favorable based on the available evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term follow-up data. Further research is needed to evaluate the long-term safety and effectiveness of the device, as well as its performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Crux Vena Cava Filter System?
The device is indicated for patients at risk for pulmonary embolism who cannot undergo anticoagulation therapy, such as those with contraindications or recurrent venous thromboembolism despite anticoagulation.
What outcomes have been reported in clinical studies?
Clinical studies have reported the device's effectiveness in preventing pulmonary embolism, with favorable safety and effectiveness outcomes demonstrated in trials like the RETRIEVE trial.
What complications have been reported?
Safety data from evidence indicate complications such as device migration, filter fracture, and thrombosis at the filter site, though these are considered relatively infrequent.
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.
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