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rotarex atherectomy system
Bard Peripheral Vascular
Summary: The Rotarex Atherectomy System is a mechanical device used for the excision of atherosclerotic plaques and thrombi in peripheral arteries. It is primarily used in treating lower limb ischemia. Key evidence highlights its effectiveness in both acute and chronic settings.
FDA Clearance Information
Pathway 510K
Number K242757 ↗
Decision Date January 30, 2025
Product Code MCW
Device Class Class 2
Evidence 0 studies
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
The Rotarex Atherectomy System is a rotational excisional device designed to remove atherosclerotic plaques and thrombi from peripheral arteries. It is intended for use in patients with peripheral arterial disease to restore blood flow and alleviate symptoms of ischemia.
Clinical Applications
Common clinical scenarios for the Rotarex Atherectomy System include treatment of acute and chronic lower limb ischemia, limb graft occlusion post-endovascular aneurysm repair, and aortoiliac endograft thrombosis. It is used in both elective and emergency settings.
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 in both acute and chronic ischemic conditions. It has been shown to successfully treat limb graft occlusions and aortoiliac endograft thrombosis, improving patient outcomes.
Safety Profile
Reported complications include arterial dissections and potential for restenosis. However, the studies generally indicate a favorable safety profile with manageable adverse events.
Evidence Limitations
The evidence is limited by the small sample sizes and lack of randomized controlled trials. Further research is needed to establish long-term outcomes and comparative effectiveness against other treatment modalities.
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.
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.