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phoenix 5f tracking atherectomy catheter phoenix 6f tracking atherectomy catheter phoenix 7d deflecting atherectomy ca

Atheromed

Summary: The Phoenix atherectomy catheters are used for removing atherosclerotic plaque from blood vessels. They are primarily used by interventional cardiologists and vascular surgeons in procedures to restore blood flow.

FDA Clearance Information

Pathway 510K
Decision Date January 17, 2014
Product Code MCW
Device Class Class 2
Evidence 8 studies

The Phoenix atherectomy catheters were cleared through the FDA 510(k) pathway on January 17, 2014. Manufactured by Atheromed, these devices are classified as Class II under product code MCW.

What It Is

The Phoenix atherectomy catheters are medical devices designed to remove plaque from blood vessels. They work by cutting and capturing plaque, allowing for minimally invasive treatment of peripheral artery disease. The catheters come in different sizes and configurations to accommodate various vessel diameters and anatomical challenges.

Clinical Applications

These catheters are commonly used in the treatment of peripheral artery disease, particularly in the lower extremities. They are utilized in interventional cardiology and vascular surgery settings. Patients who benefit from these procedures often have symptoms of claudication or critical limb ischemia, where restoring blood flow is crucial.

Indications for Use

The FDA indications for the Phoenix catheters include the removal of atherosclerotic plaque in patients with peripheral artery disease. This means they are used to treat blockages in blood vessels outside the heart, particularly in the legs.

Practical Considerations

The Phoenix catheters are available in different sizes, typically ranging from 5F to 7F, to suit various vessel sizes. They are compatible with standard guidewires and require careful technique to navigate and treat affected vessels effectively.

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 catheter used for?

It is used to remove atherosclerotic plaque from blood vessels, particularly in the peripheral arteries.

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 plaque in peripheral artery disease, aiding in restoring blood flow in affected vessels.

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.

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