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stent support guide catheter
Medtronic Vascular
Summary: The stent support guide catheter by Medtronic Vascular is a device used in vascular interventions to support stent placement. Key evidence highlights its role in improving procedural outcomes in endovascular procedures.
FDA Clearance Information
Pathway
510K
Number
K010579 ↗
Decision Date
November 21, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The stent support guide catheter received FDA clearance through the 510(k) pathway on November 21, 2001. It is manufactured by Medtronic Vascular and classified as a Class 2 medical device.
What It Is
The stent support guide catheter is designed to facilitate the delivery and placement of stents within the vascular system. It provides support and stability during endovascular procedures, ensuring accurate stent deployment.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, particularly in cases requiring precise stent positioning. It is utilized in both coronary and peripheral vascular interventions.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. The studies span from 2023 to 2025, providing insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the use of the stent support guide catheter improves procedural success rates and facilitates accurate stent placement. It has been associated with enhanced recanalization in mechanical thrombectomy for acute ischemic stroke and improved outcomes in endovascular procedures.
Safety Profile
Reported complications include potential access-site complications and device-related issues during procedures. However, the overall safety profile is favorable, with minimal adverse events noted in the reviewed studies.
Evidence Limitations
There are gaps in long-term outcome data and a need for more extensive studies to establish consensus on best practices. Variability in study designs and patient populations limits the generalizability of findings.
Frequently Asked Questions
What are the clinical indications for stent support guide catheter?
The device is indicated for use in vascular interventions requiring stent placement, particularly in venous stenting procedures.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success and accurate stent placement, with enhanced outcomes in mechanical thrombectomy for stroke.
What complications have been reported?
Reported complications include access-site issues and device-related challenges, though overall safety is favorable.
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.