📋 FDA Reference

1 8mm x 149cm phoenix atherectomy system 2 2mm x 149cm phoenix atherectomy system 2 4mm x 130cm phoenix atherectomy system

Volcano Atheromed

FDA Clearance Information

Pathway 510K

Number K172386 ↗

Decision Date August 24, 2017

Product Code MCW

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.

Clinical Applications

The Phoenix Atherectomy System is commonly used in interventional cardiology and vascular surgery settings. It is suitable for patients with peripheral artery disease, especially those with complex lesions or calcified plaque. The device is typically used in outpatient or hospital catheterization labs, where its ability to precisely remove plaque can improve patient outcomes and reduce the need for more invasive procedures.

Indications for Use

The device is indicated for patients with peripheral artery disease, specifically for those with atherosclerotic plaque in their peripheral arteries. It is used to improve blood flow and reduce symptoms associated with blocked or narrowed arteries.

Practical Considerations

The Phoenix Atherectomy System comes in various sizes, including 1.8mm, 2.2mm, and 2.4mm diameters, allowing for flexibility in treating different vessel sizes. It is compatible with standard guidewires and requires careful technique to ensure effective plaque removal without damaging the vessel wall.

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.

Related Device Categories

Atherectomy Devices