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1 8mm x 149cm Phoenix Atherectomy System 2 2mm x 149cm Phoenix Atherectomy System 2 4mm x 130cm Phoenix Atherectomy System
Product: Phoenix 1.5mm x 149cm 4F Atherectomy Catheter — all models and sizes
Summary: The Phoenix Atherectomy System is a device used for removing atherosclerotic plaque from blood vessels. It is primarily used by interventional cardiologists and vascular surgeons to treat peripheral artery disease.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172386 ↗
Decision Date ?
August 24, 2017
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
8 studies
The Phoenix Atherectomy System was cleared through the FDA 510(k) pathway on August 24, 2017. Manufactured by Volcano Atheromed, it is classified as a Class 2 medical device.
What It Is
The Phoenix Atherectomy System is a minimally invasive device designed to remove plaque from peripheral arteries. It operates by using a rotating cutter to shave plaque from the vessel walls, which is then captured and removed from the body. This device is particularly useful in treating peripheral artery disease, helping to restore blood flow and alleviate symptoms such as claudication.
FDA-Cleared Indications
- Removal of peripheral arterial plaque in patients with atherosclerotic disease.
- Treatment of lesions in peripheral arteries when atherectomy is clinically appropriate.
- Use in the peripheral vasculature under fluoroscopic guidance by trained clinicians.
Clinical Applications
- Directional atherectomy of atherosclerotic plaque in peripheral arteries.
- Plaque removal during endovascular treatment of peripheral artery disease.
- Treatment of selected peripheral arterial stenoses or occlusions before or with adjunctive balloon angioplasty or stenting, when consistent with the device labeling.
- Use in a catheterization or endovascular laboratory with imaging guidance.
Practical Considerations
- The listed configuration includes 2.0 mm x 149 cm, 4.0 mm x 130 cm, and 8.0 mm x 149 cm systems; the appropriate size depends on vessel diameter, lesion characteristics, and access anatomy.
- The device is advanced over a compatible guidewire and used with fluoroscopic imaging. Operators must follow the current manufacturer instructions for guidewire, sheath, vessel-size, and lesion requirements.
- Atherectomy can be followed by balloon angioplasty, drug-coated balloon treatment, or stenting when clinically indicated; treatment selection depends on the lesion and patient.
- The system is not automatically considered MRI safe. MRI conditions should be confirmed in the current device labeling before scanning a patient with any retained or implanted component.
- Potential complications include vessel dissection or perforation, distal embolization, thrombosis, bleeding at the access site, infection, contrast reaction, and need for additional treatment. Contraindications and warnings should be reviewed in the current instructions for use.
Linked Studies (8)
PubMed • 2024
Multicenter comparison of Etest, Vitek2 and BD Phoenix to broth microdilution for beta-lactam susceptibility testing of Streptococcus pneumonia.
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.
Vascular medicine (London, England)
View Source →PubMed • 2023
Crossing complex infrapopliteal lesions utilizing a front-end cutting technique: A report of two cases with a novel rotational atherectomy device.
SAGE open medical case reports
View Source →PubMed • 2022
Acute Real-World Outcomes From the Phoenix Post-Approval Registry.
The Journal of invasive cardiology
Other View Source →PubMed • 2022
Phoenix atherectomy for patients with peripheral artery disease.
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2019
Hybrid atherectomy for lower extremity peripheral arterial disease.
Vascular
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2017
Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study.
Vascular
View Source →Frequently Asked Questions
What is the Phoenix Atherectomy System used for?
It is used to remove atherosclerotic plaque from peripheral arteries in patients with peripheral artery disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque in peripheral arteries to improve blood flow in patients with peripheral artery disease.
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.