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asahi corsair pro
Asahi Intecc
Summary: The Asahi Corsair Pro is a microcatheter used primarily in percutaneous coronary interventions (PCI) for chronic total occlusions (CTO). Key evidence highlights its utilization in guidewire and microcatheter procedures.
FDA Clearance Information
Pathway
510K
Number
K161126 ↗
Decision Date
August 25, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Corsair Pro was cleared by the FDA via the 510(k) pathway on August 25, 2016. It is manufactured by Asahi Intecc and classified as a Class 2 device.
What It Is
The Asahi Corsair Pro is a microcatheter designed for use in percutaneous coronary interventions, specifically for navigating chronic total occlusions. It facilitates the delivery of guidewires and other interventional devices through complex vascular pathways.
Clinical Applications
The device is commonly used in chronic total occlusion percutaneous coronary interventions (CTO PCI), particularly in scenarios requiring precise guidewire navigation and support. It is instrumental in both antegrade and retrograde approaches.
Evidence Summary
The available literature includes three studies, ranging from 2011 to 2021, focusing on guidewire and microcatheter utilization in CTO PCI. These studies include retrospective and prospective analyses.
Reported Outcomes
Published studies report that the Asahi Corsair Pro is effective in facilitating guidewire passage in complex CTO cases. It is noted for its utility in both antegrade and retrograde approaches, enhancing procedural success rates.
Safety Profile
Reported complications include potential vessel injury due to microcatheter manipulation. However, specific adverse events related to the Asahi Corsair Pro are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically evaluating the Asahi Corsair Pro. Further research is needed to assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Asahi Corsair Pro?
The Asahi Corsair Pro is indicated for use in percutaneous coronary interventions, particularly in chronic total occlusions.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of guidewire passage in complex CTO cases, enhancing procedural success.
What complications have been reported?
Reported complications include potential vessel injury, though specific adverse events are not detailed in the 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.