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revolution peripheral atherectomy system revolution peripheral atherectomy guidewire
Rex Medical, L.P.
Summary: The Revolution Peripheral Atherectomy System is a device used for the treatment of peripheral arterial disease (PAD). It is primarily used to remove atherosclerotic plaque to improve blood flow. Key evidence highlights its effectiveness and safety in treating femoropopliteal and below-knee PAD.
FDA Clearance Information
Pathway
510K
Number
K191419 ↗
Decision Date
September 12, 2019
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Revolution Peripheral Atherectomy System was cleared by the FDA via the 510(k) pathway on September 12, 2019. It is manufactured by Rex Medical, L.P. and classified as a Class 2 device.
What It Is
The Revolution Peripheral Atherectomy System is a medical device designed to remove atherosclerotic plaque from peripheral arteries. It is used in the clinical setting to treat peripheral arterial disease, particularly in the femoropopliteal and below-knee regions.
Clinical Applications
This device is commonly used in interventional procedures for patients with peripheral arterial disease to improve blood flow and alleviate symptoms such as claudication. It is often employed as an adjunct to percutaneous transluminal angioplasty and stenting.
Evidence Summary
The available literature includes 7 studies, encompassing randomized controlled trials, prospective, and retrospective studies. The studies span from 1996 to 2025, providing a comprehensive overview of the device's safety and efficacy.
Reported Outcomes
Published studies report that the Revolution Peripheral Atherectomy System is effective in improving blood flow in patients with peripheral arterial disease. The device has shown promise in reducing symptoms and improving quality of life. However, the data on long-term outcomes is limited.
Safety Profile
Reported complications include risks of distal embolization and arterial perforation, as noted in the studies. The MAUDE database highlights adverse events associated with similar atherectomy systems, underscoring the need for careful patient selection and procedural technique.
Evidence Limitations
The evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term safety and efficacy, as well as to compare outcomes with other treatment modalities.
Frequently Asked Questions
What are the clinical indications for Revolution Peripheral Atherectomy System?
The device is indicated for the treatment of peripheral arterial disease, particularly in the femoropopliteal and below-knee regions.
What outcomes have been reported in clinical studies?
Studies report improved blood flow and symptom relief in patients with peripheral arterial disease, though long-term outcomes are less well-documented.
What complications have been reported?
Safety data indicate risks of distal embolization and arterial perforation, consistent with other atherectomy devices.
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.