Rotarex Atherectomy System
Bard Peripheral Vascular, Inc.
Product: SET RotarexS 8 F x 85 cm — all models and sizes
FDA Clearance Information
The Rotarex Atherectomy System is cleared through the FDA 510(k) pathway on January 30, 2025, by Bard Peripheral Vascular. It is classified as a Class 2 device under product code MCW.
What It Is
FDA-Cleared Indications
- Excision of atherosclerotic plaque from peripheral arteries.
- Excision of thrombus from peripheral arteries.
- Treatment of peripheral arterial disease when removal of plaque or thrombotic material is indicated.
Clinical Applications
- Mechanical atherectomy of diseased lower-extremity peripheral arteries.
- Removal of thrombus contributing to acute lower-limb ischemia.
- Treatment of chronic peripheral arterial occlusive disease with plaque and obstructive material.
- Removal of obstructive material from peripheral arterial segments to improve blood flow.
Reported off-label uses
- Treatment of thrombosed peripheral bypass grafts or endografts when use is not specifically included in the device labeling.
- Treatment of aortoiliac endograft thrombosis in selected cases.
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.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The system is intended for peripheral vascular use; the specific catheter size, treated-vessel diameter, lesion length and guidewire requirements must match the current device labeling.
- It is generally used under fluoroscopic or other angiographic imaging through vascular access, commonly femoral access, with anticoagulation and adjunctive balloon angioplasty or stenting when clinically appropriate.
- Potential complications include vessel injury, perforation, dissection, distal embolization, thrombosis, hemolysis and bleeding or hematoma at the access site.
- MRI safety and conditions depend on the specific Rotarex catheter and system components; confirm the current manufacturer labeling before MRI.
- Contraindications, warnings and handling requirements should be reviewed in the current instructions for use, including limitations related to vessel anatomy, guidewire compatibility and heavily calcified or unsuitable lesions.
Frequently Asked Questions
What are the clinical indications for Rotarex Atherectomy System?
The Rotarex Atherectomy System is indicated for the treatment of peripheral arterial disease, particularly in cases of acute and chronic lower limb ischemia and limb graft occlusion.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful revascularization and improved outcomes in patients with lower limb ischemia and limb graft occlusions.
What complications have been reported?
Safety data from evidence indicate complications such as arterial dissections and restenosis, though these are generally manageable.