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wingman crossing catheter
Reflow Medical
Summary: The Wingman Crossing Catheter is a device used for crossing chronic total occlusions in peripheral arteries. Key evidence highlights its efficacy in challenging calcified lesions and chronic total occlusions.
FDA Clearance Information
Pathway
510K
Number
K151880 ↗
Decision Date
August 7, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Wingman Crossing Catheter was cleared by the FDA through the 510(k) pathway on August 7, 2015. It is manufactured by Reflow Medical and classified as a Class 2 device.
What It Is
The Wingman Crossing Catheter is designed to assist in crossing chronic total occlusions in peripheral arteries. It features a nitinol/stainless steel beveled tip, facilitating penetration through occluded vessels.
Clinical Applications
Commonly used in endovascular procedures to treat chronic total occlusions, particularly in the femoropopliteal artery. It is beneficial in cases with heavily calcified lesions where traditional methods may fail.
Evidence Summary
The literature includes 7 studies, ranging from case series to prospective and retrospective studies, published between 2023 and 2025. These studies evaluate the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report a success rate of 40.7% for crossing chronic total occlusions with the Wingman system, with an overall procedure success rate of 100%. The device shows promise in treating femoropopliteal artery occlusions, especially in non-severe calcification cases.
Safety Profile
Reported complications include embolism and perforation, each occurring in one case. The studies highlight the need for careful patient selection to minimize these risks.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of randomized controlled trials. Further research is needed to establish long-term outcomes and compare efficacy with other devices.
Frequently Asked Questions
What are the clinical indications for Wingman Crossing Catheter?
The Wingman Crossing Catheter is indicated for use in crossing chronic total occlusions in peripheral arteries, particularly in the femoropopliteal region.
What outcomes have been reported in clinical studies?
Clinical studies report a 40.7% success rate in crossing chronic total occlusions, with an overall procedure success rate of 100%.
What complications have been reported?
Reported complications include embolism and perforation, each noted in one case within the studied population.
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.