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guidezilla guide extension catheter
Boston Scientific
Summary: The Guidezilla guide extension catheter is a device used primarily in interventional cardiology to facilitate complex procedures. Key evidence highlights its use in transradial coronary interventions and neuroendovascular procedures.
FDA Clearance Information
Pathway
510K
Number
K123765 ↗
Decision Date
March 19, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Guidezilla guide extension catheter was cleared by the FDA via the 510(k) pathway on March 19, 2013. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The Guidezilla guide extension catheter is designed to provide additional support and facilitate the delivery of interventional devices in complex vascular procedures. It is commonly used in percutaneous coronary interventions (PCI) and other challenging vascular interventions.
Clinical Applications
This device is frequently used in scenarios involving complex coronary artery lesions, such as those with severe calcification or tortuosity. It is also applied in neuroendovascular interventions to navigate challenging vessel anatomy.
Evidence Summary
The literature includes 10 studies, comprising case reports, case series, and observational studies, published between 2019 and 2024. These studies explore the device's application in various interventional procedures.
Reported Outcomes
Published studies report that the Guidezilla catheter effectively facilitates complex coronary and neuroendovascular procedures, improving procedural success rates. It has been shown to aid in the delivery of stents and other devices in challenging anatomical situations.
Safety Profile
Reported complications include potential vessel trauma due to the catheter's rigidity and the risk of dissection during insertion. However, these events are relatively infrequent and often manageable with appropriate technique.
Evidence Limitations
The current evidence is limited by the small sample sizes and the predominance of case series and observational studies. Further research with larger, randomized controlled trials is needed to better understand the device's efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for Guidezilla guide extension catheter?
The Guidezilla catheter is indicated for use in complex coronary and neuroendovascular procedures where additional support is needed to deliver interventional devices.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success rates in complex interventions, particularly in challenging anatomical situations.
What complications have been reported?
Safety data indicate potential complications such as vessel trauma and dissection, though these are relatively rare.
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.