📋 FDA Reference
Retrox RX 53-bp Retrox RX 60-bp Retrox RX 45-jbp Retrox RX 53-jbp Model Numbers 124 396 124 397 124 395 124 000
Summary: The Retrox RX series by Biotronik are inferior vena cava (IVC) filters used to prevent pulmonary embolism. They are typically used by interventional radiologists or vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K981083 ↗
Decision Date ?
July 22, 1998
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Retrox RX series received FDA clearance via the 510(k) pathway on July 22, 1998. Manufactured by Biotronik, these devices are classified as Class III under product code DTB.
What It Is
The Retrox RX series are medical devices designed as inferior vena cava (IVC) filters. They are implanted into the IVC to capture blood clots and prevent them from reaching the lungs, thereby reducing the risk of pulmonary embolism. These devices are typically inserted via a minimally invasive procedure using a catheter.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for venous thromboembolism.
- Use when anticoagulation therapy is contraindicated, ineffective, or cannot provide adequate protection.
- Use in patients with thromboembolic disease, such as deep vein thrombosis, when an IVC filter is clinically indicated.
Clinical Applications
- Catheter-based placement of an IVC filter in patients at risk for pulmonary embolism.
- Protection from pulmonary embolism in patients with deep vein thrombosis or other venous thromboembolism.
- Pulmonary embolism prevention when anticoagulant medication cannot be used or has not provided adequate protection.
- Placement before or around selected high-risk surgical situations when the treating team determines that an IVC filter is indicated.
Reported off-label uses
- Use for prevention of pulmonary embolism in selected patients with temporary high thromboembolic risk when the labeled clinical circumstances do not clearly apply.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The Retrox RX series includes different models and sizes; the selected filter must match the patient's IVC diameter, anatomy, and the device's labeled deployment requirements.
- Placement is generally performed through a venous access site, commonly the internal jugular or femoral vein, using fluoroscopic imaging and a delivery catheter.
- Clinicians should confirm the device's retrieval status and any manufacturer-specified retrieval window before implantation when temporary protection is intended.
- MRI safety and conditions must be verified from the device labeling and institutional device records before an MRI examination; this record does not establish MRI compatibility.
- An IVC filter does not treat the underlying clot and does not replace anticoagulation when anticoagulation is safe and clinically appropriate. Potential complications include filter migration, tilt, fracture, perforation, recurrent deep vein thrombosis, and difficulty with retrieval.
Procedures that use this device
Frequently Asked Questions
What is the Retrox RX series used for?
The Retrox RX series is used as an inferior vena cava filter to prevent pulmonary embolism in patients at risk of venous thromboembolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for patients at risk of pulmonary embolism, particularly when anticoagulation is contraindicated or ineffective.
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.