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single needle hemodialysis bfc-161
Sorensen Research
Summary: The single needle hemodialysis BFC-161 by Sorensen Research is a dialysis-access device cleared by the FDA. It is primarily used for hemodialysis with a single needle approach. Key evidence highlights its renewed interest due to advancements in technology and changing patient demographics.
FDA Clearance Information
Pathway
510K
Number
K761081 ↗
Decision Date
December 6, 1976
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The single needle hemodialysis BFC-161 was cleared by the FDA through the 510(k) pathway on December 6, 1976. It is manufactured by Sorensen Research and classified as a Class 2 device.
What It Is
The BFC-161 is a hemodialysis device designed for single needle access, facilitating blood filtration and dialysis in patients with renal failure. It is intended for use in clinical settings where traditional dual-needle access is not feasible or preferred.
Clinical Applications
This device is commonly used in scenarios where patients have limited vascular access or when a less invasive dialysis method is desired. It is particularly useful in elderly patients or those with cardiovascular complications.
Evidence Summary
The literature includes 10 studies ranging from 2015 to 2023, encompassing various study types such as RCTs, prospective, and retrospective studies. These studies explore the efficacy and safety of single needle hemodialysis.
Reported Outcomes
Published studies report that single needle hemodialysis can be effective in providing adequate dialysis treatment, with some studies indicating improved patient comfort and reduced vascular access complications. However, outcomes vary depending on patient demographics and specific clinical settings.
Safety Profile
Reported complications include potential for increased recirculation and reduced dialysis efficiency in some cases. However, advancements in technology have mitigated some of these risks, making the procedure safer for a broader range of patients.
Evidence Limitations
Current evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish long-term outcomes and to optimize protocols for different patient populations.
Frequently Asked Questions
What are the clinical indications for single needle hemodialysis BFC-161?
The device is indicated for patients requiring hemodialysis, particularly those with limited vascular access or when a single needle approach is preferred.
What outcomes have been reported in clinical studies?
Studies have reported effective dialysis treatment with improved patient comfort and reduced vascular access complications in certain populations.
What complications have been reported?
Safety data indicates potential for increased recirculation and reduced dialysis efficiency, though advancements have reduced these 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.