📋 FDA Reference

2 4mm x 130cm phoenix deflecting atherectomy system 1 5mm x 149cm phoenix atherectomy system

Volcano Atheromed

FDA Clearance Information

Pathway 510K

Number K211518 ↗

Decision Date June 14, 2021

Product Code MCW

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.

Clinical Applications

This device is commonly used in procedures to treat peripheral artery disease (PAD) in the lower extremities. It is utilized in both hospital and outpatient settings by vascular surgeons and interventional radiologists. The system is suitable for patients with significant arterial blockages who are at risk of ischemic complications.

Indications for Use

The Phoenix Atherectomy System is indicated for patients with peripheral arterial disease, particularly those with significant plaque buildup in the lower extremities. It is used to improve blood flow and reduce symptoms such as claudication.

Practical Considerations

The device comes in various sizes, including 4mm and 1.5mm diameters, to accommodate different vessel sizes. It is compatible with standard guidewires and catheters, making it versatile for various procedural needs. Proper technique is essential to ensure effective plaque removal and minimize complications.

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.

Related Device Categories

Atherectomy Devices