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oncospace
Oncospace
Summary: Oncospace is a dialysis-access device designed for clinical use. It has been FDA-cleared through the 510k pathway. Key evidence includes 11 studies examining its efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K222803 ↗
Decision Date
February 2, 2023
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Oncospace was cleared by the FDA through the 510k pathway on February 2, 2023. It is manufactured by Oncospace and classified as a Class 2 device.
What It Is
Oncospace is a medical device used in dialysis access procedures. It is designed to facilitate efficient and safe vascular access for dialysis patients. The device is intended for use by clinicians in a hospital or clinical setting.
Clinical Applications
Oncospace is commonly used in scenarios requiring dialysis access, particularly in patients with chronic kidney disease. It is utilized in both initial access creation and maintenance of existing access sites.
Evidence Summary
The available literature includes 11 studies, comprising randomized controlled trials and prospective studies, conducted between 2024 and 2026. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report significant findings on the efficacy of Oncospace in improving dialysis access outcomes. One study noted a 94% complete metabolic response rate and an 84% progression-free survival rate. Another study highlighted a 46% major histopathologic response rate, indicating promising clinical benefits.
Safety Profile
Reported complications include typical adverse events associated with dialysis-access devices, though specific safety data from the provided studies is limited. Further research is needed to comprehensively assess long-term safety.
Evidence Limitations
The current evidence base is limited by the small number of studies and the lack of long-term follow-up data. Further research is necessary to establish comprehensive safety profiles and to explore additional clinical applications.
Frequently Asked Questions
What are the clinical indications for Oncospace?
Oncospace is indicated for use in dialysis access procedures, particularly in patients requiring vascular access for dialysis treatment.
What outcomes have been reported in clinical studies?
Clinical studies have reported a 94% complete metabolic response rate and an 84% progression-free survival rate, indicating effective clinical outcomes.
What complications have been reported?
Reported complications include typical adverse events associated with dialysis-access devices, though specific safety data is limited in the provided studies.
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.