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guidezilla ii guide extension catheter guidezilla ii long guide extension catheter
Boston Scientific
Summary: The Guidezilla II is a guide extension catheter used primarily in percutaneous coronary interventions to enhance guide catheter support. Key evidence highlights its use in complex saphenous vein graft interventions and innovative auxiliary support techniques.
FDA Clearance Information
Pathway
510K
Number
K163314 ↗
Decision Date
March 23, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Guidezilla II guide extension catheter, manufactured by Boston Scientific, was cleared via the FDA 510(k) pathway on March 23, 2017. It is classified as a Class 2 device under product code DQY.
What It Is
The Guidezilla II is a guide extension catheter designed to provide enhanced backup support during percutaneous coronary interventions (PCI). It facilitates deep intubation and coaxial alignment of the guide catheter, improving access to coronary arteries.
Clinical Applications
Commonly used in complex PCI procedures, the Guidezilla II is particularly beneficial in cases involving calcified or tortuous coronary anatomy. It aids in the delivery of stents and other interventional devices by stabilizing the guide catheter.
Evidence Summary
The available literature includes a case report and a study on complex saphenous vein graft interventions, published between 2019 and 2025. These studies explore innovative techniques and the device's role in challenging PCI scenarios.
Reported Outcomes
Published studies report successful use of the Guidezilla II in enhancing guide catheter support and facilitating complex PCI procedures. The device has been shown to improve access and delivery in challenging coronary anatomies, such as calcified saphenous vein grafts.
Safety Profile
Reported complications include the potential for vascular trauma due to deep intubation. However, specific adverse events were not detailed in the provided evidence, indicating a need for further safety data.
Evidence Limitations
The evidence is limited to a small number of studies, primarily case reports, which may not provide comprehensive safety and efficacy data. Further research is needed to establish long-term outcomes and broader clinical applicability.
Frequently Asked Questions
What are the clinical indications for Guidezilla II?
The Guidezilla II is indicated for use in percutaneous coronary interventions to enhance guide catheter support, particularly in complex coronary anatomies.
What outcomes have been reported in clinical studies?
Studies have reported successful enhancement of guide catheter support and improved delivery of interventional devices in challenging PCI scenarios.
What complications have been reported?
Reported complications include potential vascular trauma, but specific adverse events were not detailed in the available studies.
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.