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Rotarex Atherectomy System
Product: SET RotarexS 8 F x 85 cm — all models and sizes
Summary: The Rotarex Atherectomy System is a device used for mechanical thrombectomy and atherectomy in arterial applications. Key evidence highlights its effectiveness in treating lower limb ischemia and arterial occlusions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211738 ↗
Decision Date ?
September 14, 2021
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Rotarex Atherectomy System was cleared by the FDA through the 510(k) pathway on September 14, 2021. It is manufactured by C.R. Bard and classified as a Class 2 device under product code MCW.
What It Is
The Rotarex Atherectomy System is a rotational excisional device designed for the removal of thrombus and atheromatous plaque from peripheral arteries. It is intended for use in patients with peripheral arterial disease to restore blood flow.
FDA-Cleared Indications
- Removal of thrombus from peripheral arteries.
- Removal of atheromatous plaque from peripheral arteries.
- Treatment of peripheral arterial occlusive disease when mechanical atherectomy or thrombectomy is clinically appropriate.
Clinical Applications
- Mechanical thrombectomy of peripheral arterial thrombus.
- Atherectomy of peripheral arterial plaque.
- Treatment of selected lower-extremity arterial occlusions.
- Treatment of femoropopliteal arterial disease when the anatomy and device labeling are appropriate.
Evidence Summary
The available literature includes 12 studies, comprising case series and prospective studies, published between 2020 and 2025. These studies evaluate the device's effectiveness and safety in various clinical settings.
Reported Outcomes
Published studies report that the Rotarex Atherectomy System is effective in revascularizing occluded arteries, particularly in cases of lower limb ischemia and limb graft occlusion. The device has shown success in both acute and chronic settings, with improvements in blood flow and limb salvage rates.
Safety Profile
Reported complications include arterial dissections and potential for vessel injury, as observed in some studies. However, the overall safety profile is considered acceptable within the context of its clinical use.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of randomized controlled trials. Further research is needed to establish long-term outcomes and to compare the device's efficacy against other treatment modalities.
Practical Considerations
- The system is used through an appropriately sized vascular access sheath or catheter, with device selection based on the treated vessel and the manufacturer’s instructions for use.
- Treatment is performed under fluoroscopic imaging, usually through femoral or other suitable arterial access, with anticoagulation and adjunctive angioplasty or stenting used when clinically indicated.
- The device is intended for peripheral arterial applications and should not be assumed to be cleared for coronary, cerebral, or venous thrombectomy.
- MRI safety depends on the specific system components and whether any component remains in the patient; consult the current labeling before MRI.
- Potential complications include bleeding or hematoma at the access site, distal embolization, vessel injury or perforation, dissection, thrombosis, hemolysis, infection, contrast reaction, and recurrent occlusion.
Frequently Asked Questions
What are the clinical indications for Rotarex Atherectomy System?
The Rotarex Atherectomy System is indicated for mechanical thrombectomy and atherectomy in patients with peripheral arterial disease, particularly for treating lower limb ischemia and arterial occlusions.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful revascularization and improved blood flow in occluded arteries, with positive outcomes in both acute and chronic ischemic conditions.
What complications have been reported?
Safety data from evidence indicate complications such as arterial dissections and potential vessel injury, though these are generally manageable within clinical practice.
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.