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itc guiding catheter
Interventional Therapeutics
Summary: The ITC Guiding Catheter by Interventional Therapeutics is a Class 2 medical device cleared by the FDA for use in venous stenting procedures. Key evidence suggests its role in reducing post-dural puncture headaches.
FDA Clearance Information
Pathway
510K
Number
K913052 ↗
Decision Date
November 22, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ITC Guiding Catheter was cleared via the FDA 510(k) pathway on November 22, 1991. It is manufactured by Interventional Therapeutics and classified as a Class 2 device.
What It Is
The ITC Guiding Catheter is designed for use in venous stenting procedures. It facilitates the delivery of stents to targeted venous sites, aiding in the management of vascular conditions.
Clinical Applications
Commonly used in interventional cardiology, the ITC Guiding Catheter assists in the placement of stents within venous structures. It is particularly useful in procedures requiring precise catheter guidance.
Evidence Summary
The literature includes five studies, ranging from retrospective to prospective designs, published between 2008 and 2025. These studies explore various clinical applications and outcomes associated with the ITC Guiding Catheter.
Reported Outcomes
Published studies report that the ITC Guiding Catheter is associated with a reduction in the incidence of post-dural puncture headaches, though the difference was not statistically significant. The requirement for epidural blood patches was also lower in the ITC group.
Safety Profile
Reported complications include a potential association between higher BMI and reduced risk of post-dural puncture headaches, although this finding was not statistically significant. No other significant safety concerns were noted in the studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish definitive conclusions regarding the efficacy and safety of the ITC Guiding Catheter.
Frequently Asked Questions
What are the clinical indications for ITC Guiding Catheter?
The ITC Guiding Catheter is indicated for use in venous stenting procedures, aiding in the precise delivery of stents to targeted venous sites.
What outcomes have been reported in clinical studies?
Clinical studies have reported a reduction in post-dural puncture headaches and a decreased requirement for epidural blood patches in patients using the ITC Guiding Catheter.
What complications have been reported?
Safety data suggests a potential association between higher BMI and reduced risk of post-dural puncture headaches, though this was not statistically significant. No major complications were reported.
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.