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guiding catheter
Interventional Therapeutics
Summary: The guiding catheter by Interventional Therapeutics is a device used primarily in percutaneous coronary interventions. Key evidence highlights its efficacy in complex procedures such as chronic total occlusions.
FDA Clearance Information
Pathway
510K
Number
K923518 ↗
Decision Date
January 12, 1993
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The guiding catheter was cleared by the FDA through the 510(k) pathway on January 12, 1993. It is manufactured by Interventional Therapeutics and classified as a Class 2 device.
What It Is
A guiding catheter is a flexible tube used to navigate and deliver interventional devices to target sites within the vascular system. It is primarily used in percutaneous coronary interventions to provide support and facilitate the delivery of therapeutic devices.
Clinical Applications
Guiding catheters are commonly used in scenarios such as coronary angioplasty, stent placement, and other vascular interventions. They are essential in procedures requiring precise navigation through complex vascular anatomies.
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 interventional procedures.
Reported Outcomes
Published studies report that guiding catheters are effective in facilitating complex percutaneous coronary interventions, including chronic total occlusions. They provide necessary support and enable successful navigation and device delivery in challenging vascular anatomies.
Safety Profile
Reported complications include coronary artery perforation, which is a rare but serious risk during interventions. Other studies highlight the importance of proper catheter positioning to minimize adverse events.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically focusing on guiding catheter outcomes. Further research is needed to explore long-term safety and efficacy 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, particularly in complex cases such as chronic total occlusions and challenging vascular anatomies.
What outcomes have been reported in clinical studies?
Studies have reported that guiding catheters are effective in supporting complex interventions, with successful navigation and device delivery in difficult cases.
What complications have been reported?
Safety data from evidence indicate complications such as coronary artery perforation and the need for careful catheter positioning to avoid adverse events.
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.