phoenix hemodialysis delivery system
Gambro Renal Products
FDA Clearance Information
The Phoenix Hemodialysis Delivery System was cleared by the FDA through the 510(k) pathway on May 20, 2011. It is manufactured by Gambro Renal Products and is classified as a Class 2 device.
What It Is
Clinical Applications
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
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 are the clinical indications for Phoenix Hemodialysis Delivery System?
The device is indicated for use in patients requiring hemodialysis due to renal failure, both in chronic and acute settings.
What outcomes have been reported in clinical studies?
Studies have reported effective renal replacement therapy during healthcare crises and successful management of end-stage renal disease.
What complications have been reported?
Safety data indicate complications related to central venous access, particularly during the COVID-19 pandemic, but no specific device-related adverse events were detailed.