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Revolution Peripheral Atherectomy System
Rex Medical, L.P.
Product: Revolution Peripheral Atherectomy System — all models and sizes
Summary: The Revolution Peripheral Atherectomy System is a device used in the treatment of peripheral arterial disease (PAD). It is primarily used to remove atherosclerotic plaque from peripheral arteries. Key evidence highlights its safety and effectiveness in treating femoropopliteal and below-knee PAD.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K212351 ↗
Decision Date ?
December 15, 2021
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Revolution Peripheral Atherectomy System was cleared by the FDA via the 510(k) pathway on December 15, 2021. It is manufactured by Rex Medical, L.P. and is classified as a Class 2 medical device.
What It Is
The Revolution Peripheral Atherectomy System is a medical device designed to remove atherosclerotic plaque from peripheral arteries. It operates through a rotational mechanism to excise plaque, facilitating improved blood flow in patients with peripheral arterial disease.
FDA-Cleared Indications
- Treatment of atherosclerotic disease in peripheral arteries.
- Removal or reduction of plaque to improve blood flow in affected peripheral arteries.
- Use in endovascular treatment of peripheral arterial disease in the labeled anatomy and lesion types described in the device instructions for use.
Clinical Applications
- Rotational atherectomy of peripheral arterial lesions.
- Treatment of femoropopliteal peripheral arterial disease.
- Treatment of below-knee peripheral arterial disease.
- Plaque modification before or with balloon angioplasty when additional lesion preparation is indicated.
- Adjunctive treatment during peripheral endovascular revascularization.
Evidence Summary
The available literature includes a mix of study types such as RCTs and prospective studies, with a total of 7 studies ranging from 1996 to 2025. These studies explore the safety and efficacy of atherectomy devices, including the Revolution Peripheral Atherectomy System.
Reported Outcomes
Published studies report that the Revolution Peripheral Atherectomy System is effective in removing atherosclerotic plaque, thereby improving blood flow in affected arteries. The device has shown promise in treating femoropopliteal and below-knee PAD, with positive outcomes in terms of procedural success and symptom relief.
Safety Profile
Reported complications include risks such as distal embolization and arterial perforation, which are common concerns with atherectomy procedures. However, the studies indicate that the Revolution Peripheral Atherectomy System maintains a favorable safety profile when used appropriately.
Evidence Limitations
The evidence is limited by the relatively small number of studies specifically focusing on the Revolution Peripheral Atherectomy System. Further research is needed to establish long-term outcomes and to compare its efficacy and safety with other atherectomy devices.
Practical Considerations
- The system is used over a guidewire through a vascular access sheath or catheter, with lesion crossing and device compatibility determined by the instructions for use.
- Treatment requires fluoroscopic imaging and is typically performed through femoral or another suitable arterial access site.
- The device may be used with adjunctive balloon angioplasty or stenting when clinically appropriate; the atherectomy system does not replace all other revascularization options.
- Exact catheter sizes, working lengths, guidewire requirements, lesion-length limits and vessel-diameter ranges should be verified in the current manufacturer instructions for use.
- MRI safety and conditional-use requirements depend on the specific device components and labeling; confirm the current MRI information before scanning.
Frequently Asked Questions
What are the clinical indications for Revolution Peripheral Atherectomy System?
The device is indicated for the removal of atherosclerotic plaque in patients with peripheral arterial disease, particularly in the femoropopliteal and below-knee regions.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved blood flow and symptom relief in patients treated with the Revolution Peripheral Atherectomy System, with a high rate of procedural success.
What complications have been reported?
Safety data from evidence indicate complications such as distal embolization and arterial perforation, which are inherent risks of atherectomy procedures.
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.