📊 Evidence-Based Reference

1 8 mm phoenix atherectomy catheter 2 2 mm phoenix atherectomy catheter phoenix handle phoenix wire support clip

Atheromed

FDA Clearance Information

Pathway 510K

Number K140944 ↗

Decision Date August 22, 2014

Product Code MCW

Device Class Class 2

Evidence 8 studies

The Phoenix Atherectomy Catheter was cleared by the FDA through the 510(k) pathway on August 22, 2014. It is manufactured by Atheromed and classified as a Class 2 device.

What It Is

The Phoenix Atherectomy Catheter is a minimally invasive device designed for the removal of atherosclerotic plaque in peripheral arteries. It is intended for use in endovascular procedures to treat peripheral artery disease.

Clinical Applications

Commonly used in the treatment of peripheral artery disease, the Phoenix Atherectomy Catheter is applied in scenarios involving the common femoral and popliteal arteries, where plaque removal is necessary to restore blood flow.

Evidence Summary

The available literature includes two studies, one published in 2024 and another in 2022, assessing the device's safety and effectiveness. These studies encompass various methodologies, including prospective and retrospective analyses.

Reported Outcomes

Published studies report that the Phoenix Atherectomy Catheter is effective in treating de novo lesions in the common femoral and popliteal arteries. The device demonstrated positive peri- and postprocedural outcomes, with a focus on freedom from clinically driven target lesion revascularization.

Safety Profile

Reported complications include potential perforation and peripheral embolization during procedures. These safety endpoints were specifically monitored in the studies to assess the device's risk profile.

Evidence Limitations

The evidence is limited by the small number of studies and the lack of long-term follow-up data. Further research is needed to confirm the device's effectiveness across diverse patient populations and clinical settings.

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 are the clinical indications for Phoenix Atherectomy Catheter?

The device is indicated for the endovascular treatment of peripheral artery disease, specifically in the common femoral and popliteal arteries.

What outcomes have been reported in clinical studies?

Studies have reported effective plaque removal and positive peri- and postprocedural outcomes, with a focus on freedom from target lesion revascularization.

What complications have been reported?

Safety data indicate potential complications such as perforation and peripheral embolization during procedures.

Related Device Categories

Atherectomy Devices