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asahi corsair microcatheter
Asahi Intecc
Summary: The Asahi Corsair Microcatheter is a device used in percutaneous coronary interventions, particularly for chronic total occlusions. Key evidence highlights its role in guidewire support and microcatheter utilization.
FDA Clearance Information
Pathway
510K
Number
K151103 ↗
Decision Date
June 23, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Corsair Microcatheter was cleared by the FDA via the 510(k) pathway on June 23, 2015. It is manufactured by Asahi Intecc and classified as a Class 2 device.
What It Is
The Asahi Corsair Microcatheter is designed to facilitate the delivery of guidewires and other interventional devices during percutaneous coronary interventions. It is particularly useful in navigating complex coronary anatomy.
Clinical Applications
Commonly used in chronic total occlusion (CTO) percutaneous coronary interventions, the Asahi Corsair Microcatheter aids in guidewire support and crossing challenging lesions.
Evidence Summary
The literature includes 8 studies ranging from 2017 to 2023, encompassing RCTs, prospective, retrospective, and case series. These studies focus on equipment utilization in CTO interventions.
Reported Outcomes
Published studies report successful utilization of the Asahi Corsair Microcatheter in facilitating guidewire passage during CTO interventions. Outcomes include effective guidewire support and successful lesion crossing.
Safety Profile
Reported complications include a serious case of a fractured guide wire perforating the coronary artery and ascending aorta, necessitating surgical intervention.
Evidence Limitations
Current evidence is limited by the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Asahi Corsair Microcatheter?
The Asahi Corsair Microcatheter is indicated for use in percutaneous coronary interventions, particularly in chronic total occlusions.
What outcomes have been reported in clinical studies?
Studies report successful guidewire support and lesion crossing during CTO interventions using the Asahi Corsair Microcatheter.
What complications have been reported?
Safety data indicate a serious complication involving a fractured guide wire perforating the coronary artery and ascending aorta.
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.