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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 510K
Number K981198 ↗
Decision Date August 7, 1998
Product Code DQY
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.
Clinical Applications
Commonly used in transradial coronary brachytherapy and renal percutaneous transluminal angioplasty and stenting. It provides a minimally invasive approach for vascular access and intervention.
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.
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.