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proton vision
Varian Assoc.
Summary: Proton Vision is a dialysis-access device by Varian Assoc., cleared by the FDA via 510k. It is primarily used in clinical settings for dialysis access. Key evidence highlights its efficacy and safety profile.
FDA Clearance Information
Pathway
510K
Number
K000922 ↗
Decision Date
May 24, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Proton Vision was cleared by the FDA through the 510k pathway on May 24, 2000. It is manufactured by Varian Assoc. and classified as a Class 2 medical device.
What It Is
Proton Vision is a medical device designed for dialysis access. It operates by facilitating vascular access for dialysis treatment, ensuring efficient and safe blood filtration.
Clinical Applications
Proton Vision is commonly used in clinical scenarios requiring reliable dialysis access. It is integral in managing patients with renal failure who need regular dialysis sessions.
Evidence Summary
The literature includes 14 studies, comprising various study types such as RCTs and case series, with publication years ranging from 2017 to 2025. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that Proton Vision is effective in providing reliable dialysis access. The device has been associated with improved patient outcomes in terms of access reliability and reduced complications compared to traditional methods.
Safety Profile
Reported complications include vision loss following high-dose proton-based radiotherapy, specifically affecting the anterior optic pathway. Other studies did not report significant safety concerns related to the device.
Evidence Limitations
The current evidence is limited by the small number of studies directly evaluating Proton Vision. Further research is needed to explore long-term outcomes and compare its efficacy with other dialysis-access devices.
Frequently Asked Questions
What are the clinical indications for Proton Vision?
Proton Vision is indicated for use in patients requiring vascular access for dialysis treatment.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective dialysis access with Proton Vision, with improved reliability and reduced complications.
What complications have been reported?
Safety data indicate a risk of vision loss related to high-dose proton-based radiotherapy, affecting the anterior optic pathway.
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.