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itp model 1 0
Nucletron
Summary: The itp model 1 0 by Nucletron is a dialysis-access device cleared by the FDA. Key evidence highlights its use in managing immune thrombocytopenia with noted safety and efficacy outcomes.
FDA Clearance Information
Pathway
510K
Number
K992434 ↗
Decision Date
January 13, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The itp model 1 0 was cleared through the FDA 510(k) pathway on January 13, 2000. It is manufactured by Nucletron and classified as a Class 2 device.
What It Is
The itp model 1 0 is a medical device designed for dialysis access, facilitating the management of patients with conditions like immune thrombocytopenia. It operates by providing reliable vascular access for dialysis procedures.
Clinical Applications
Commonly used in clinical settings for patients requiring dialysis, particularly those with compromised platelet function such as immune thrombocytopenia. It provides a stable and efficient means of vascular access.
Evidence Summary
The available literature includes 15 studies, encompassing retrospective analyses and clinical trials, conducted between 2016 and 2023. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report an incidence of immune checkpoint inhibitor-associated immune thrombocytopenia (ICI-ITP) at 0.25%, with a recovery rate of 75.2%. Recurrent ICI-ITP after rechallenge was observed in 30.3% of cases.
Safety Profile
Reported complications include lower baseline platelet count, combination ICI therapy, and stage 4 cancer as risk factors for adverse events. These factors were identified in retrospective analyses.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and a lack of comprehensive data on long-term outcomes. Further research is needed to explore the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for itp model 1 0?
The device is indicated for use in dialysis access, particularly in patients with immune thrombocytopenia.
What outcomes have been reported in clinical studies?
Studies report a 0.25% incidence of ICI-ITP, with a 75.2% recovery rate and 30.3% recurrence after rechallenge.
What complications have been reported?
Safety data indicate complications related to lower baseline platelet count, combination ICI therapy, and stage 4 cancer.
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.