đź“Š Evidence-Based Reference
Asahi Corsair Microcatheter
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 ?
510(k)
Number ?
K151103 ↗
Decision Date ?
June 23, 2015
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Facilitation of guidewire placement and exchange during percutaneous coronary interventions.
- Delivery of interventional devices through the coronary vasculature.
- Navigation of tortuous or difficult coronary anatomy under fluoroscopic guidance.
Clinical Applications
- Guidewire support during coronary angioplasty and stent procedures.
- Guidewire exchange during complex percutaneous coronary intervention.
- Crossing or treating difficult coronary lesions when additional catheter support is needed.
- Percutaneous coronary intervention for selected chronic total occlusions.
Reported off-label uses
- Use in selected peripheral vascular interventions as a support or delivery microcatheter.
- Use in complex endovascular procedures outside the coronary circulation, depending on catheter specifications and institutional practice.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The catheter is available in different lengths and configurations; the selected size must match the guidewire, guide catheter, vascular access route, and target anatomy.
- It is used over a compatible guidewire through a guiding catheter or sheath under fluoroscopic imaging.
- Operators should follow the current manufacturer instructions for torque, advancement, flushing, and device compatibility; excessive force can cause vessel injury or catheter damage.
- MRI safety depends on the exact model and labeling. Do not assume MRI compatibility; verify the current device-specific MR conditions before scanning.
- Potential complications include coronary dissection, perforation, spasm, thrombosis, embolization, bleeding, infection, and catheter fracture or entrapment.
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.