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shadow catheter
Simpson Interventions
Summary: The shadow catheter by Simpson Interventions is a Class 2 medical device cleared by the FDA for use in venous stents. It is supported by 15 peer-reviewed studies, providing evidence on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K240885 ↗
Decision Date
December 19, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The shadow catheter received FDA clearance through the 510(k) pathway on December 19, 2024. Manufactured by Simpson Interventions, it is classified as a Class 2 device.
What It Is
The shadow catheter is a medical device designed for use in venous stenting procedures. It facilitates the placement and stabilization of stents within venous structures, aiding in the treatment of venous obstructions.
Clinical Applications
Commonly used in procedures involving venous stents, the shadow catheter is applied in cases where venous flow needs to be restored or maintained. It is particularly useful in interventional radiology and vascular surgery settings.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs, case reports, and retrospective analyses, published between 2021 and 2024.
Reported Outcomes
Published studies report that the shadow catheter effectively aids in the placement of venous stents, contributing to improved venous flow and reduced obstruction. Clinical outcomes indicate a high success rate in stent deployment with minimal procedural complications.
Safety Profile
Reported complications include catheter-related thrombosis and potential misplacement, as highlighted in case reports. These events, although rare, underscore the importance of precise catheter placement and monitoring.
Evidence Limitations
The evidence is limited by the small sample sizes and the heterogeneity of study designs. Further research is needed to establish long-term outcomes and to explore the device's efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for shadow catheter?
The shadow catheter is indicated for use in venous stenting procedures, particularly in cases of venous obstruction requiring stent placement.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful stent deployment and improved venous flow with the use of the shadow catheter.
What complications have been reported?
Safety data indicate potential complications such as catheter-related thrombosis and misplacement, though these are infrequent.
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.