đź“Š Evidence-Based Reference
Asahi Corsair Microcatheter
Summary: The Asahi Corsair Microcatheter is used in percutaneous coronary interventions, particularly for chronic total occlusions. Key evidence highlights its role in guidewire support and microcatheter utilization during these procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083127 ↗
Decision Date ?
February 3, 2009
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 February 3, 2009. 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 primarily used in procedures involving chronic total occlusions.
FDA-Cleared Indications
- Used during percutaneous coronary interventions to facilitate guidewire placement and exchange.
- Used to provide support for the delivery of interventional devices in coronary vessels.
- Intended for use in the coronary vasculature under fluoroscopic imaging guidance.
Clinical Applications
- Guidewire support during coronary angioplasty and stent procedures.
- Guidewire exchange during complex percutaneous coronary intervention.
- Support for crossing or treating difficult coronary lesions, including chronic total occlusions.
- Delivery of compatible interventional devices within the coronary arteries.
Reported off-label uses
- Use in selected peripheral vascular interventions as a support or delivery microcatheter, when chosen by the treating physician.
- Use in complex collateral-channel or retrograde coronary techniques beyond the routine labeled application.
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 available literature includes 8 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. These studies span from 2017 to 2023.
Reported Outcomes
Published studies report that the Asahi Corsair Microcatheter is effective in supporting guidewire navigation during chronic total occlusion interventions. It has been associated with successful outcomes in complex coronary procedures.
Safety Profile
Reported complications include a serious case of a fractured guide wire perforating the coronary artery and ascending aorta, necessitating surgical intervention. Overall, the device is considered safe when used appropriately.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically evaluating the Asahi Corsair Microcatheter. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The catheter must be matched to the guidewire, guide catheter, and other devices used in the procedure; available configurations and dimensions vary by model.
- It is advanced over a guidewire under continuous fluoroscopic guidance, with careful attention to vessel injury, dissection, perforation, and catheter damage.
- Compatibility with contrast media, guidewires, and other devices should be confirmed in the current manufacturer instructions for use.
- MRI safety depends on the specific model and whether the catheter remains in the patient; consult the current labeling before MRI.
- Contraindications and warnings include unsuitable vascular anatomy, severe vessel spasm or disease, and inability to safely access or navigate the target vessel.
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 device delivery in complex coronary interventions, particularly in chronic total occlusions.
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.