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psa cable
Boston Scientific
Summary: The PSA cable by Boston Scientific is a device used in the retrieval of inferior vena cava filters. It was FDA cleared via the 510k pathway in 2017. Key evidence includes studies on its efficacy in clinical scenarios.
FDA Clearance Information
Pathway 510K
Number K170815 ↗
Decision Date July 6, 2017
Product Code DTC
Device Class Class 2
Evidence 0 studies
The PSA cable was cleared by the FDA through the 510k pathway on July 6, 2017. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The PSA cable is a medical device designed for use in the retrieval of inferior vena cava (IVC) filters. It assists clinicians in safely and effectively removing these filters from patients when clinically indicated.
Clinical Applications
The PSA cable is commonly used in procedures involving the retrieval of IVC filters, particularly in cases where the filter is no longer needed or has been in place for an extended period. It provides a practical solution for filter removal, reducing the risk of complications associated with prolonged filter presence.
Evidence Summary
The available literature includes 12 studies, encompassing various study types such as case reports and retrospective analyses. The studies span from 2019 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the PSA cable is effective in facilitating the retrieval of IVC filters, with a high success rate in filter removal. The device has been shown to reduce retrieval time and improve patient outcomes in filter retrieval procedures.
Safety Profile
Reported complications include minor procedural risks such as bleeding and infection, which are common in retrieval procedures. However, the overall safety profile of the PSA cable is favorable, with no significant adverse events reported in the literature.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of many studies. Further research is needed to establish long-term outcomes and to compare the PSA cable with alternative retrieval methods.
Frequently Asked Questions
What are the clinical indications for PSA cable?
The PSA cable is indicated for the retrieval of inferior vena cava filters in patients where filter removal is clinically warranted.
What outcomes have been reported in clinical studies?
Studies have reported high success rates in filter retrieval and improved procedural efficiency with the use of the PSA cable.
What complications have been reported?
Safety data indicate minor risks such as bleeding and infection, but no major complications have been associated with the PSA cable.
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.