📋 FDA Reference

2 4mm x 127 cm phoenix atherectomy deflecting system

Volcano Atheromed

FDA Clearance Information

Pathway 510K

Number K151145 ↗

Decision Date May 26, 2015

Product Code MCW

Device Class Class 2

Evidence 8 studies

The Phoenix Atherectomy Deflecting System was cleared through the FDA 510k pathway on May 26, 2015. Manufactured by Volcano Atheromed, it is classified as a Class 2 device under product code MCW.

What It Is

The Phoenix Atherectomy Deflecting System is a catheter-based device designed to remove atherosclerotic plaque from peripheral blood vessels. It features a rotating cutter that shaves plaque from the vessel wall, which is then captured and removed from the body. This device is part of the atherectomy category, offering a minimally invasive option for treating peripheral artery disease (PAD).

Clinical Applications

This device is commonly used in interventional cardiology and vascular surgery settings, particularly for patients with peripheral artery disease. It is often employed in procedures where plaque removal is necessary to restore blood flow in narrowed or blocked arteries. The system is suitable for use in both hospital and outpatient settings, and is typically used in adult patients with PAD.

Indications for Use

The Phoenix Atherectomy Deflecting System is indicated for the removal of plaque in peripheral arteries. It is specifically designed for patients with peripheral artery disease, where plaque buildup has led to reduced blood flow in the limbs.

Practical Considerations

The device is available in a 4mm x 127cm size, making it suitable for a range of vessel sizes. It is compatible with standard guidewires and requires a specific technique to ensure effective plaque removal. Clinicians should be trained in its use to optimize outcomes.

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 Deflecting System used for?

It is used for removing atherosclerotic plaque from peripheral arteries to improve blood flow in patients with peripheral artery disease.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons commonly use this device in treating peripheral artery disease.

What are the FDA-cleared indications?

The device is indicated for the removal of plaque in peripheral arteries in patients with peripheral artery disease.

Related Device Categories

Atherectomy Devices