đź“‹ FDA Reference
2 4mm x 130cm Phoenix Deflecting Atherectomy System 1 5mm x 149cm Phoenix Atherectomy System
Product: Phoenix 1.5mm x 149cm 4F Atherectomy Catheter — all models and sizes
Summary: The Phoenix Atherectomy System is a medical device used to remove plaque from blood vessels. It is primarily used by vascular surgeons and interventional cardiologists to treat peripheral arterial disease.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211518 ↗
Decision Date ?
June 14, 2021
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 June 14, 2021. 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 atherosclerotic plaque from blood vessels. It features a rotating cutter and a deflecting tip to navigate and treat complex lesions. This system is particularly useful in treating peripheral arterial disease, helping to restore blood flow and alleviate symptoms.
FDA-Cleared Indications
- Atherectomy of peripheral arterial lesions in the lower extremities.
- Removal of atherosclerotic plaque from peripheral arteries to help restore or improve blood flow.
- Use in patients with peripheral arterial disease when endovascular plaque removal is clinically appropriate.
Clinical Applications
- Treatment of plaque-filled lesions in lower-extremity peripheral arteries.
- Directional atherectomy during an endovascular procedure for peripheral arterial disease.
- Plaque removal before or with other treatments, such as balloon angioplasty or stent placement, when indicated.
- Treatment of symptomatic peripheral arterial disease, including blood-flow-limiting lesions associated with claudication.
Practical Considerations
- The FDA record lists a 4 mm x 130 cm Phoenix Deflecting Atherectomy System and a 5 mm x 149 cm Phoenix Atherectomy System.
- The system is delivered through the vascular system under fluoroscopic imaging, typically through femoral or other peripheral arterial access.
- Device selection depends on the treated vessel diameter, lesion characteristics, access anatomy and guidewire compatibility specified in the current instructions for use.
- MRI safety and conditional-use details must be confirmed in the current manufacturer labeling; the device should not be assumed to be MRI safe.
- Contraindications, vessel-size limits, guidewire requirements and procedural warnings should be checked in the current instructions for use before treatment.
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 plaque from blood vessels, particularly in patients with peripheral arterial disease.
What specialties typically use this device?
Vascular surgeons and interventional cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for treating peripheral arterial disease by removing plaque from the arteries to improve blood flow.
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.