đź“Š Evidence-Based Reference
1 8 Mm Phoenix Atherectomy Catheter 2 2 Mm Phoenix Atherectomy Catheter Phoenix Handle Phoenix Wire Support Clip
Atheromed
Product: Phoenix 2.2mm x 130cm 6F Atherectomy System — all models and sizes
Summary: The Phoenix Atherectomy Catheter by Atheromed is used for endovascular treatment of peripheral artery disease. Key evidence highlights its safety and effectiveness in treating common femoral and popliteal arteries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140944 ↗
Decision Date ?
August 22, 2014
Product Code ?
MCW Catheter, Peripheral, Atherectomy
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.
FDA-Cleared Indications
- Atherectomy in peripheral arteries affected by atherosclerotic disease.
- Treatment of lesions in the common femoral and popliteal arteries.
- Removal of plaque to help restore or improve blood flow in the treated peripheral artery.
Clinical Applications
- Endovascular atherectomy of atherosclerotic lesions in the common femoral artery.
- Endovascular atherectomy of atherosclerotic lesions in the popliteal artery.
- Plaque removal during a peripheral artery disease intervention when the treating physician determines atherectomy is appropriate.
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.
Practical Considerations
- The listed system includes 8 mm and 2 mm Phoenix atherectomy catheters, a Phoenix handle, and a Phoenix wire-support clip; the appropriate catheter size depends on vessel diameter and lesion characteristics.
- The device is used over a guidewire through an endovascular access site, with fluoroscopic imaging to guide positioning and treatment.
- Patients should be assessed for contraindications to peripheral endovascular intervention, including unsuitable vessel anatomy, inability to obtain vascular access, or uncorrected bleeding risk.
- MRI safety depends on the specific device components and their status after the procedure; the product labeling and current MRI safety information should be checked before scanning.
- Atherectomy may be combined with balloon angioplasty, stenting, medication, or surgery when clinically appropriate. Potential complications include bleeding, embolization, vessel injury, thrombosis, and the need for additional treatment.
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.
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.