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retrox rx 45-jbp 124774 53-jbp 124775 53-bp 124776 60-124777
Biotronik
Summary: The Retrox RX is an IVC filter manufactured by Biotronik, used to prevent pulmonary embolism in patients with contraindications to anticoagulation. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K990483 ↗
Decision Date
June 3, 1999
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Retrox RX received FDA clearance through the 510(k) pathway on June 3, 1999. It is manufactured by Biotronik and classified as a Class III device.
What It Is
The Retrox RX is an inferior vena cava (IVC) filter designed to prevent blood clots from traveling to the lungs, which can cause a pulmonary embolism. It is implanted in the inferior vena cava, the large vein carrying deoxygenated blood from the lower body to the heart. The device works by capturing clots before they reach the lungs, providing an alternative to anticoagulation therapy for patients who cannot tolerate blood thinners.
Clinical Applications
The Retrox RX is commonly used in patients at high risk of pulmonary embolism who cannot use anticoagulation therapy due to bleeding risks or other contraindications. It is often deployed in hospital settings, particularly in interventional radiology suites or operating rooms. The device is used in a variety of patient populations, including those undergoing major surgery, trauma patients, and individuals with a history of deep vein thrombosis.
Indications for Use
The FDA indications for the Retrox RX include prevention of pulmonary embolism in patients who have contraindications to anticoagulation therapy. It is intended for use in patients at risk of developing blood clots that could travel to the lungs.
Practical Considerations
The Retrox RX is available in various sizes to accommodate different patient anatomies. It is important to ensure proper placement in the inferior vena cava to maximize efficacy and minimize complications. Compatibility with imaging equipment is essential for accurate deployment.
Frequently Asked Questions
What is the Retrox RX used for?
The Retrox RX is used to prevent pulmonary embolism in patients who cannot take anticoagulants.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Retrox RX.
What are the FDA-cleared indications?
The Retrox RX is indicated for preventing pulmonary embolism in patients with contraindications to anticoagulation therapy.
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.