đź“Š Evidence-Based Reference
Phoenix Hemodialysis Delivery System
Gambro Renal Products
Summary: The Phoenix Hemodialysis Delivery System is a device used for hemodialysis in patients with renal failure. It is primarily used in clinical settings to provide renal replacement therapy. Key evidence includes studies on its use during healthcare crises and its role in managing end-stage renal disease.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K103832 ↗
Decision Date ?
May 20, 2011
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
8 studies
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
The Phoenix Hemodialysis Delivery System is a medical device designed to perform hemodialysis, a process that filters waste and excess fluids from the blood in patients with renal failure. It is intended for use in clinical settings to provide renal replacement therapy.
FDA-Cleared Indications
- For hemodialysis treatment of patients with renal failure.
- For use in clinical settings to provide renal replacement therapy.
Clinical Applications
- Hemodialysis for patients with end-stage kidney disease who require maintenance dialysis.
- Hemodialysis for patients with acute kidney injury when renal replacement therapy is needed.
- Treatment in hospital dialysis units and outpatient dialysis centers.
- Removal of metabolic waste and excess fluid from the blood through an extracorporeal dialysis circuit.
Evidence Summary
The available literature includes four studies, with types ranging from retrospective to observational studies. The studies span from 1997 to 2020, providing insights into the device's application in various clinical scenarios.
Reported Outcomes
Published studies report that the Phoenix Hemodialysis Delivery System is effective in providing renal replacement therapy during healthcare crises, such as the COVID-19 pandemic. It has been used successfully in managing end-stage renal disease and maintaining vascular access in critical care settings.
Safety Profile
Reported complications include issues related to central venous access during hemodialysis, as highlighted in studies conducted during the COVID-19 pandemic. No specific adverse events directly related to the device were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of randomized controlled trials specifically evaluating the Phoenix Hemodialysis Delivery System. Further research is needed to assess long-term outcomes and device-specific complications in diverse patient populations.
Practical Considerations
- The system requires connection to a compatible extracorporeal blood circuit, dialyzer, dialysate supply, vascular access, and appropriate water treatment infrastructure.
- Treatment is performed through vascular access such as an arteriovenous fistula, arteriovenous graft, or dialysis catheter.
- The machine is operated by trained dialysis personnel and requires monitoring of blood flow, dialysate flow, pressures, fluid removal, alarms, and patient vital signs.
- The system is not itself an implanted device; MRI compatibility considerations primarily involve the patient’s vascular access, catheters, and other connected equipment. The dialysis machine should not be taken into the MRI scanner room unless specifically cleared by its labeling.
- Treatment may be inappropriate or require modification in patients with unstable blood pressure, active bleeding, severe infection, inadequate vascular access, or other conditions determined by the treating nephrology team.
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 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.
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.