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porous surfaced platinum iridium
Cordis
Summary: The porous surfaced platinum iridium device by Cordis is primarily used in ablation devices and IVC filters. Key evidence highlights its application in clinical settings with a focus on material stability and performance.
FDA Clearance Information
Pathway
510K
Number
K821889 ↗
Decision Date
August 6, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on August 6, 1982. Manufactured by Cordis, it is classified as a Class 3 device under product code DTB.
What It Is
The device features a porous surface made of platinum and iridium, designed for use in medical applications such as tumor ablation and IVC filters. It leverages the properties of these metals to enhance performance and stability in clinical settings.
Clinical Applications
Commonly used in procedures requiring tumor ablation and the placement of IVC filters, this device is integral in managing conditions that necessitate precise and durable medical interventions.
Evidence Summary
The literature includes 10 studies, with a mix of RCTs, prospective, and retrospective designs, spanning from 2019 to 2025. These studies explore the device's material properties and clinical applications.
Reported Outcomes
Published studies report that the device demonstrates good performance in terms of material stability and effectiveness in clinical applications. The use of platinum and iridium contributes to its durability and efficiency in medical procedures.
Safety Profile
Reported complications include issues related to material degradation and the need for long-term stability assessments. However, specific adverse events were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of detailed safety outcomes and specific clinical efficacy data. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for porous surfaced platinum iridium?
The device is indicated for use in tumor ablation and as an IVC filter, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies highlight the device's stability and effectiveness in clinical applications, particularly in material performance.
What complications have been reported?
Safety data from evidence indicate potential material degradation, but specific adverse events are not detailed.
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.