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quick-cross extreme support catheter quick-cross select support catheter
Spectranetics
Summary: The Quick-Cross Extreme Support Catheter by Spectranetics is a device used in venous stenting procedures. It was FDA-cleared via the 510(k) pathway in 2015. Key evidence includes studies on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K150201 ↗
Decision Date
February 27, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Quick-Cross Extreme Support Catheter was cleared by the FDA through the 510(k) pathway on February 27, 2015. It is manufactured by Spectranetics and classified as a Class 2 device under product code DQY.
What It Is
The Quick-Cross Extreme Support Catheter is designed to facilitate the delivery of stents in venous procedures. It provides support and guidance for stent placement, enhancing procedural efficiency and accuracy.
Clinical Applications
This catheter is commonly used in venous stenting procedures, particularly in cases requiring enhanced support for precise stent delivery. It is utilized in interventional radiology and vascular surgery settings.
Evidence Summary
The available literature includes 10 studies, covering a range of study types such as RCTs and systematic reviews, published between 2021 and 2024. These studies provide insights into the device's performance and safety.
Reported Outcomes
Published studies report that the Quick-Cross Extreme Support Catheter is effective in improving the precision of stent placement in venous procedures. The device has shown favorable outcomes in terms of procedural success and reduced intervention time.
Safety Profile
Reported complications include typical procedural risks associated with catheter use, such as infection and vascular injury. However, the studies reviewed did not highlight any unique safety concerns specific to this device.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device, with some studies focusing on broader procedural outcomes rather than device-specific performance. Further research is needed to establish long-term safety and efficacy.
Frequently Asked Questions
What are the clinical indications for Quick-Cross Extreme Support Catheter?
The device is indicated for use in venous stenting procedures to facilitate the delivery and placement of stents.
What outcomes have been reported in clinical studies?
Studies have reported improved precision in stent placement and procedural success with the use of the Quick-Cross Extreme Support Catheter.
What complications have been reported?
Safety data indicate typical risks such as infection and vascular injury, with no unique complications specific to the device.
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.