📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K010579 ↗
Decision Date ?
November 21, 2001
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use for vascular diagnostic or interventional procedures.
- Provides a pathway and support for the delivery of intravascular devices, including stents, when compatible with the catheter and procedure.
Clinical Applications
- Supporting catheter-based vascular interventions.
- Facilitating the positioning and deployment of compatible intravascular stents.
- Providing access and device support during image-guided endovascular procedures.
Reported off-label uses
- Use as a support catheter for complex peripheral or venous interventions beyond the specific device labeling may occur in clinical practice, based on operator judgment and institutional protocols.
- Use to improve backup support during difficult endovascular device delivery may be described for selected interventions, but this is not necessarily an FDA-cleared indication for a specific device.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The catheter size, length, working diameter, and tip configuration must match the access vessel, target anatomy, guidewire, and stent delivery system.
- Use requires fluoroscopic or other appropriate imaging guidance and trained vascular-intervention personnel.
- Compatibility with guidewires, introducer sheaths, contrast agents, and intended stent systems should be confirmed before use.
- The FDA record provided does not establish a specific MRI safety designation; consult the current manufacturer labeling for MR safety and conditional-use information.
- Potential complications are related to catheterization and vascular intervention and may include bleeding, vessel injury, thrombosis, embolization, infection, contrast reaction, or need for additional treatment.
Procedures that use this device
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.