đź“Š Evidence-Based Reference
1 8mm x 149 Cm Phoenix Atherectomy Catheter 2 2mm x 149 Cm Phoenix Atherectomy Catheter Phoenix Handle Phoenix Wire Support Clip
Product: Phoenix 1.5mm x 149cm 4F Atherectomy Catheter — all models and sizes
Summary: The Phoenix Atherectomy Catheter is a device used for atherectomy procedures, primarily to remove plaque from blood vessels. Key evidence includes FDA clearance and linked studies on imaging techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K143328 ↗
Decision Date ?
December 19, 2014
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
8 studies
The Phoenix Atherectomy Catheter was cleared by the FDA via the 510(k) pathway on December 19, 2014. It is manufactured by Volcano Atheromed and classified as a Class 2 device.
What It Is
The Phoenix Atherectomy Catheter is designed for atherectomy, a procedure to remove atherosclerotic plaque from blood vessels. It is used to improve blood flow in patients with peripheral artery disease.
FDA-Cleared Indications
- For percutaneous atherectomy in peripheral arteries.
- For treating stenotic or occlusive lesions caused by atherosclerotic plaque in peripheral vessels.
- For use with compatible guidewire support during image-guided endovascular treatment.
Clinical Applications
- Removal of plaque from peripheral arterial lesions during atherectomy.
- Treatment of peripheral artery stenosis or occlusion when plaque modification or removal is needed.
- Endovascular treatment of lower-extremity peripheral arterial disease under fluoroscopic imaging.
- Use with balloon angioplasty or stenting when plaque removal is part of a planned peripheral intervention.
Evidence Summary
The available literature includes three studies, primarily retrospective and survey-based, spanning from 1998 to 2007. These studies focus on imaging techniques relevant to device application.
Reported Outcomes
Published studies report on the efficacy of imaging techniques in detecting conditions relevant to the use of atherectomy devices. However, specific outcomes related to the Phoenix Atherectomy Catheter itself are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with imaging and interventional procedures, but specific safety data for the Phoenix Atherectomy Catheter is not detailed in the provided studies.
Evidence Limitations
The evidence lacks direct studies on the Phoenix Atherectomy Catheter, with existing literature focusing on imaging techniques. Further research is needed to evaluate device-specific outcomes and safety.
Practical Considerations
- The record lists 2 mm and 8 mm catheter sizes, each 149 cm long; the appropriate size depends on vessel diameter and lesion characteristics.
- The system includes a Phoenix handle, wire support clip and atherectomy catheters. Compatibility with the guidewire, sheath and other procedural equipment should be confirmed before use.
- The catheter is intended for image-guided vascular procedures and requires appropriate access, anticoagulation and embolic-risk management according to the labeling and institutional protocol.
- MRI safety should be determined from the current device labeling and the exact implanted or retained components; a temporary catheter used during a procedure is not the same as an implanted device.
- Potential concerns include vessel perforation, dissection, distal embolization, thrombosis, bleeding and incomplete lesion treatment. Patient selection and contraindications should follow the manufacturer's current instructions for use.
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 use in atherectomy procedures to remove plaque from blood vessels, particularly in patients with peripheral artery disease.
What outcomes have been reported in clinical studies?
The studies provided focus on imaging techniques rather than direct outcomes of the Phoenix Atherectomy Catheter.
What complications have been reported?
The provided evidence does not detail specific complications for the Phoenix Atherectomy Catheter, focusing instead on imaging-related risks.
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.