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asahi caravel
Asahi Intecc
Summary: The Asahi Caravel is a microcatheter used in interventional cardiology, particularly for navigating complex vascular pathways. It is primarily used by interventional cardiologists during procedures like chronic total occlusion (CTO) percutaneous coronary interventions (PCI).
FDA Clearance Information
Pathway
510K
Number
K152447 ↗
Decision Date
January 22, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Caravel, manufactured by Asahi Intecc, received FDA clearance through the 510(k) pathway on January 22, 2016. It is classified as a Class 2 medical device under product code DQY.
What It Is
The Asahi Caravel is a microcatheter designed to facilitate the delivery of guidewires and therapeutic devices through challenging vascular pathways. Its flexible and low-profile design allows for enhanced maneuverability in tortuous vessels, making it particularly useful in complex coronary interventions. The device is constructed to support precise navigation and positioning during procedures.
Clinical Applications
The Asahi Caravel is commonly used in interventional cardiology, especially during chronic total occlusion (CTO) percutaneous coronary interventions (PCI). It is employed in settings such as catheterization labs where precise device delivery is critical. The microcatheter is suitable for patients with complex coronary artery disease requiring advanced techniques for revascularization.
Indications for Use
The FDA-cleared indications for the Asahi Caravel include its use in facilitating guidewire and device delivery during percutaneous coronary interventions. It is particularly indicated for patients with challenging vascular anatomy, such as those with chronic total occlusions.
Practical Considerations
The Asahi Caravel is available in various sizes to accommodate different procedural needs and is compatible with a range of guidewires. Clinicians should consider the vessel size and lesion complexity when selecting the appropriate microcatheter size. Its design allows for smooth navigation through tortuous vessels, aiding in successful device delivery.
Related Literature
The study titled 'Equipment utilization in chronic total occlusion percutaneous coronary interventions: Insights from the PROGRESS-CTO registry' examined the use of guidewires and microcatheters, including the Asahi Caravel, during CTO PCI procedures. Key findings highlighted the importance of selecting appropriate equipment to improve procedural success rates. Limitations included a focus on specific procedural settings, which may not generalize to all clinical environments.
Frequently Asked Questions
What is the Asahi Caravel used for?
The Asahi Caravel is used to facilitate the delivery of guidewires and devices during complex coronary interventions, such as chronic total occlusion PCI.
What specialties typically use this device?
Interventional cardiologists primarily use the Asahi Caravel in catheterization labs during coronary interventions.
What are the FDA-cleared indications?
The device is indicated for use in facilitating guidewire and device delivery in percutaneous coronary interventions, particularly in challenging vascular anatomies.
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.