Phoenix 5f Tracking Atherectomy Catheter Phoenix 6f Tracking Atherectomy Catheter Phoenix 7d Deflecting Atherectomy Ca
Atheromed
FDA Clearance Information
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
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral blood vessels in patients with peripheral artery disease.
Clinical Applications
- Endovascular atherectomy of plaque in lower-extremity peripheral arteries.
- Treatment of peripheral arterial blockages associated with symptomatic peripheral artery disease.
- Plaque removal during catheter-based procedures intended to improve blood flow in affected peripheral vessels.
Practical Considerations
- The listed Phoenix models include 5F and 6F tracking catheters and a 7F deflecting catheter configuration.
- The treating physician selects catheter size and configuration according to vessel diameter, lesion location, access route and anatomy.
- These devices are used with fluoroscopic imaging and compatible guidewire and catheter techniques; compatibility should be confirmed in the current instructions for use.
- The device is intended for peripheral vascular treatment and should not be assumed to be appropriate for coronary, cerebral or other vascular beds unless specifically labeled.
- MRI safety and conditions are not established by the supplied FDA record; consult the current manufacturer labeling before MRI.
Linked Studies (8)
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 →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 →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 →Acute Real-World Outcomes From the Phoenix Post-Approval Registry.
The Journal of invasive cardiology
Other View Source →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 →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 →Hybrid atherectomy for lower extremity peripheral arterial disease.
Vascular
RCT|prospective|retrospective|case Series|other View Source →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.