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Medtronic Zuma Guiding Catheter
Medtronics Interventional Vascular
Summary: The Medtronic Zuma Guiding Catheter is used for vascular interventions, primarily in coronary and renal procedures. Key evidence highlights successful transradial approaches in coronary brachytherapy and renal stenting.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K981198 ↗
Decision Date ?
August 7, 1998
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Medtronic Zuma Guiding Catheter was cleared via the FDA 510(k) pathway on August 7, 1998. It is manufactured by Medtronics Interventional Vascular and classified as a Class 2 device.
What It Is
The Medtronic Zuma Guiding Catheter is a medical device designed to facilitate the delivery of interventional tools during vascular procedures. It is primarily used in coronary and renal interventions to guide other devices to the target site.
FDA-Cleared Indications
- For percutaneous introduction and guidance of interventional devices within the vascular system.
- For use as a catheter during vascular diagnostic or therapeutic procedures when access and device delivery are required.
Clinical Applications
- Percutaneous vascular access for delivery of compatible interventional devices.
- Catheter guidance during endovascular procedures involving peripheral or central blood vessels.
- Use in image-guided vascular interventions when a guiding catheter is needed to reach the treatment site.
Reported off-label uses
- Use as a guiding catheter in coronary interventions, including transradial procedures, when selected by the treating physician.
- Use during renal artery angioplasty or stenting.
- Use during venous interventions such as iliac or central venous stent delivery when the catheter's specifications are compatible.
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 two studies from 2002, focusing on transradial approaches in coronary and renal interventions. These studies explore the feasibility and success of using the Zuma Guiding Catheter in these contexts.
Reported Outcomes
Published studies report successful completion of transradial coronary brachytherapy and renal stenting procedures using the Zuma Guiding Catheter. Both studies highlight the device's effectiveness in facilitating these interventions without the need for additional stenting.
Safety Profile
Reported complications include no significant adverse events in the studied procedures. The studies did not detail specific complications, indicating a favorable safety profile in the reported cases.
Evidence Limitations
The evidence is limited to two studies with small sample sizes and lacks detailed safety outcomes. Further research is needed to validate findings across larger, diverse populations and to explore long-term outcomes.
Practical Considerations
- The available record does not provide the catheter's complete size range, usable length, tip configuration, or maximum guidewire and device compatibility; clinicians should verify the current product labeling before use.
- Use fluoroscopic or other appropriate imaging guidance and maintain sterile technique during vascular access and device advancement.
- Compatibility depends on the target vessel, access route, guidewire, sheath, contrast injection requirements, and interventional device being delivered.
- MRI safety is not established by the supplied FDA record. Check the current labeling for MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.
- Potential complications are typical of percutaneous vascular catheterization and may include bleeding, hematoma, vessel injury, thrombosis, embolization, infection, contrast reaction, and loss of catheter integrity.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Medtronic Zuma Guiding Catheter?
The device is indicated for use in vascular interventions such as coronary brachytherapy and renal stenting, particularly via transradial approaches.
What outcomes have been reported in clinical studies?
Clinical studies report successful completion of procedures with effective lesion dilation and no need for additional stenting.
What complications have been reported?
Safety data from the studies indicate no significant adverse events, suggesting a favorable safety profile.
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.