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cutaneous compression device for use in hemodialysis
Robert R. Stevens
Summary: The cutaneous compression device by Robert R. Stevens is used in hemodialysis to manage vascular access. Key evidence highlights its efficacy in compression therapy.
FDA Clearance Information
Pathway
510K
Number
K964041 ↗
Decision Date
January 30, 1997
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on January 30, 1997. It is manufactured by Robert R. Stevens and classified as a Class 2 device.
What It Is
The cutaneous compression device is designed to apply pressure to the skin, aiding in hemodialysis by managing vascular access. It is intended for use in clinical settings to ensure effective blood flow during dialysis.
Clinical Applications
Commonly used in hemodialysis, this device helps maintain vascular access by applying consistent pressure. It is crucial in scenarios where stable blood flow is necessary for effective dialysis treatment.
Evidence Summary
The literature includes 15 studies, comprising RCTs, case series, and other types, published between 2016 and 2019. These studies explore the efficacy and safety of compression therapy in various clinical contexts.
Reported Outcomes
Published studies report that compression therapy is effective in managing vascular access during hemodialysis. Evidence suggests improvements in venous ulcer healing and symptom management in related conditions.
Safety Profile
Reported complications include meralgia paresthetica due to nerve compression, as seen in case reports. Safety profiles indicate minor side effects that require ergonomic considerations.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to explore long-term outcomes and optimize device ergonomics.
Frequently Asked Questions
What are the clinical indications for cutaneous compression device?
The device is indicated for use in hemodialysis to manage vascular access and ensure effective blood flow.
What outcomes have been reported in clinical studies?
Studies report effective management of vascular access and improvements in related conditions like venous ulcers.
What complications have been reported?
Safety data indicate complications such as meralgia paresthetica due to nerve compression.
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.