📋 FDA Reference

phoenix 2 4mm atherectomy plus system

Volcano Atheromed

FDA Clearance Information

Pathway 510K

Number K181877 ↗

Decision Date December 17, 2018

Product Code MCW

Device Class Class 2

Evidence 8 studies

The Phoenix 2 4mm Atherectomy Plus System was cleared through the FDA 510k pathway on December 17, 2018. Manufactured by Volcano Atheromed, it is classified as a Class 2 device under product code MCW.

What It Is

The Phoenix 2 4mm Atherectomy Plus System is a minimally invasive device designed to remove atherosclerotic plaque from peripheral blood vessels. It operates by cutting and capturing plaque in a single step, using a rotating cutting element housed within a catheter. This system is designed to improve blood flow in patients with peripheral artery disease (PAD) by debulking obstructive lesions.

Clinical Applications

This device is commonly used in interventional cardiology and vascular surgery settings, particularly for patients with peripheral artery disease. It is suitable for use in both hospital and outpatient settings, where clinicians perform endovascular procedures to restore blood flow. The Phoenix system is beneficial for patients who have complex or calcified lesions that are difficult to treat with balloon angioplasty alone.

Indications for Use

The FDA-cleared indications for the Phoenix 2 4mm Atherectomy Plus System include the treatment of peripheral artery disease by removing plaque from blood vessels. It is intended for patients with obstructive lesions that impede blood flow, particularly in the lower extremities.

Practical Considerations

The device is compatible with standard guidewires and can be used in conjunction with other endovascular tools. Its 4mm size makes it suitable for medium to large vessels. Operators should be trained in atherectomy techniques and aware of the potential for vessel injury or embolization.

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 2 4mm Atherectomy Plus System used for?

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

What specialties typically use this device?

Interventional cardiologists and vascular surgeons typically use this device in endovascular procedures.

What are the FDA-cleared indications?

The device is indicated for the treatment of peripheral artery disease by removing plaque from blood vessels, particularly in the lower extremities.

Related Device Categories

Atherectomy Devices