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vitesse 3 0
Varian Medical Systems, Oncology Systems
Summary: Vitesse 3 0 is a dialysis-access device by Varian Medical Systems, cleared by the FDA via the 510k pathway. Key evidence includes studies on its use in high-risk patients for intracranial stenosis treatment.
FDA Clearance Information
Pathway
510K
Number
K123152 ↗
Decision Date
December 7, 2012
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Vitesse 3 0 was cleared by the FDA through the 510k pathway on December 7, 2012. It is manufactured by Varian Medical Systems and classified as a Class 2 device under product code MUJ.
What It Is
The Vitesse 3 0 is a medical device designed for dialysis access, facilitating vascular access for patients requiring dialysis. It is intended for use in clinical settings to support patients with compromised renal function.
Clinical Applications
Commonly used in scenarios requiring reliable vascular access for dialysis, the Vitesse 3 0 is employed in both acute and chronic dialysis settings. It is particularly useful in patients with challenging vascular anatomy.
Evidence Summary
The available literature includes four studies, with publication years ranging from 2016 to 2019. These studies encompass various designs, including retrospective analyses and registry substudies.
Reported Outcomes
Published studies report that the Vitesse 3 0 is effective in maintaining vascular access for dialysis. One study highlighted its use in intracranial stenosis treatment, noting a 30-day stroke rate and procedural complications.
Safety Profile
Reported complications include procedural risks associated with intracranial angioplasty and stenting. The evidence suggests careful patient selection is crucial to minimize adverse events.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on specific high-risk patient groups. Further research is needed to explore broader applications and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Vitesse 3 0?
The Vitesse 3 0 is indicated for use in dialysis access, particularly in patients requiring reliable vascular access.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access and use in intracranial stenosis with noted procedural outcomes.
What complications have been reported?
Safety data indicate procedural risks, including complications from intracranial angioplasty and stenting.
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.