đź“Š Evidence-Based Reference
crux vena cava filter system femoral crux vena cava filter system jugular
Volcano
Summary: The Crux Vena Cava Filter System by Volcano is designed to prevent pulmonary embolism in patients at risk. Key evidence highlights its safety and effectiveness in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K150262 ↗
Decision Date
April 3, 2015
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Crux Vena Cava Filter System was cleared by the FDA via the 510(k) pathway on April 3, 2015. It is manufactured by Volcano and classified as a Class 2 medical device.
What It Is
The Crux Vena Cava Filter System is a medical device intended to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is used in patients who are at risk for venous thromboembolism and cannot undergo anticoagulation therapy.
Clinical Applications
Commonly used in patients at risk for pulmonary embolism who have contraindications to anticoagulation therapy. It is also used prophylactically in certain high-risk surgical or trauma patients.
Evidence Summary
The available literature includes randomized controlled trials and prospective studies, with a total of 7 studies reviewed. The studies range 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 high-risk patients. The RETRIEVE trial demonstrated its safety and effectiveness, while other studies have explored its technical success and long-term performance.
Safety Profile
Reported complications include device migration, filter fracture, and vena cava perforation. However, these events are relatively rare, and the device is generally considered safe based on the available evidence.
Evidence Limitations
The evidence is limited by a lack of long-term follow-up data and small sample sizes in some studies. Further research is needed to fully understand the long-term safety and effectiveness of the device.
Frequently Asked Questions
What are the clinical indications for Crux Vena Cava Filter System?
The device is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies have reported effective prevention of pulmonary embolism and technical success in placement.
What complications have been reported?
Safety data indicates complications such as 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.