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wingman 35 crossing catheter
Reflow Medical
Summary: The Wingman 35 Crossing Catheter is a medical device used to facilitate the crossing of challenging vascular lesions, particularly in patients with lower extremity arterial disease. It is primarily used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K173661 ↗
Decision Date
April 18, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Wingman 35 Crossing Catheter received FDA clearance through the 510(k) pathway on April 18, 2018. Manufactured by Reflow Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Wingman 35 Crossing Catheter is a specialized catheter designed to assist in navigating and crossing difficult vascular lesions, especially those with severe calcification. It features a unique bevel tip that aids in penetrating and traversing these lesions, making it a valuable tool in endovascular procedures. This device is particularly useful in cases where traditional guidewires and catheters may struggle to pass through heavily calcified or occluded vessels.
Clinical Applications
This catheter is commonly used in interventional cardiology and vascular surgery, particularly in procedures involving lower extremity arterial disease (LEAD). It is employed in settings such as hospitals and specialized vascular centers where endovascular interventions are performed. The device is beneficial for patients with peripheral artery disease (PAD) who have complex lesions that are difficult to cross with standard techniques.
Indications for Use
The Wingman 35 Crossing Catheter is indicated for use in patients with vascular lesions that are difficult to navigate, particularly those with severe calcification. It is intended for use in endovascular procedures to facilitate the crossing of these challenging lesions, thereby aiding in the treatment of peripheral artery disease.
Practical Considerations
The Wingman 35 Crossing Catheter is compatible with standard guidewires and is available in various sizes to accommodate different vessel diameters. Clinicians should be familiar with the WINNER technique, which involves the removal of the catheter's inner bevel tip to enhance crossing capability. Proper sizing and technique are crucial for optimal performance and patient outcomes.
Related Literature
A prospective cohort study investigated the use of the Wingman catheter in patients with lower extremity arterial disease complicated by severely calcified lesions. The study introduced the WINNER technique, which involves the removal of the catheter's bevel tip to improve crossing efficiency. The findings suggested that this method is both effective and safe for treating challenging calcified lesions. However, the study's limitations include its prospective nature and potential selection bias.
Frequently Asked Questions
What is the Wingman 35 Crossing Catheter used for?
It is used to facilitate the crossing of difficult vascular lesions, particularly in patients with severe calcification in peripheral arteries.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in crossing challenging vascular lesions, especially those with severe calcification, to aid in endovascular treatments.
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.