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Psa Cable
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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 ?
510(k)
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.
FDA-Cleared Indications
- Used to assist in the retrieval of inferior vena cava filters.
- Intended for endovascular use during IVC filter removal when retrieval is clinically indicated.
Clinical Applications
- Assisting with retrieval of an IVC filter through a percutaneous endovascular procedure.
- Supporting removal of an IVC filter that is no longer clinically needed.
- Assisting with retrieval of an IVC filter during a procedure performed under fluoroscopic imaging guidance.
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.
Practical Considerations
- Use should follow the current manufacturer’s instructions for use, including compatible retrieval systems, access equipment, and IVC filter types.
- The device is handled through vascular access and typically requires fluoroscopic imaging for positioning and retrieval.
- Patient selection depends on filter position, tilt, embedment, fracture, migration, thrombus, and other findings on imaging.
- Potential complications relate to vascular access and filter retrieval, including bleeding, venous injury, filter fracture or embolization, and incomplete retrieval.
- MRI safety and conditional-use information should be confirmed in the current product labeling before an MRI examination.
Procedures that use this device
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.