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guiding catheter
Boston Scientific
Summary: The guiding catheter by Boston Scientific is used in interventional procedures, primarily for vascular access. Key evidence highlights its efficacy in complex coronary interventions.
FDA Clearance Information
Pathway
510K
Number
K930476 ↗
Decision Date
February 10, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The guiding catheter by Boston Scientific was cleared through the FDA 510(k) pathway on February 10, 1994. It is classified as a Class 2 device under product code DQY.
What It Is
A guiding catheter is a medical device used to facilitate the introduction of interventional devices into the vascular system. It is primarily used in procedures such as percutaneous coronary interventions (PCI) to provide support and access to target sites.
Clinical Applications
Guiding catheters are commonly used in coronary and neuroendovascular procedures to navigate complex vascular anatomies. They are essential in interventions requiring precise catheter placement and support.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses, published between 2022 and 2024. These studies evaluate the efficacy and safety of guiding catheters in various clinical scenarios.
Reported Outcomes
Published studies report that guiding catheters are effective in facilitating complex PCI, including chronic total occlusions and distal radial access. The use of guiding catheter extensions has been highlighted for their support in challenging vascular anatomies.
Safety Profile
Reported complications include coronary artery perforation, which is a rare but serious risk. Other studies mention the potential for catheter tip detachment, requiring retrieval techniques.
Evidence Limitations
Current evidence is limited by a lack of large-scale RCTs directly comparing different guiding catheter designs. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for guiding catheter?
Guiding catheters are indicated for use in percutaneous coronary interventions and other vascular access procedures requiring catheter support.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of complex PCI, including chronic total occlusions and distal radial access, with guiding catheter use.
What complications have been reported?
Safety data indicate risks of coronary artery perforation and catheter tip detachment, though these are infrequent.
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.