FDA Clearance of ReFlow Medical Wingman35 Crossing Catheter

Following last month’s CE mark approval, now ReFlow Medical, Inc. has gained FDA clearance for its Wingman35 Crossing Catheter for use in the peripheral vasculature as well as the first U.S. clinical cases with the device.

Background

The Wingman35 Crossing Catheter is indicated to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature and enable rapid, routine, off-the-shelf lesion crossing. It allows physicians to use their .035” guidewire of choice during procedures.

Physician comments 

“My first clinical cases with the Wingman35 were impressive and consistent with my prior experience with the Wingman14,” says Dr. John R. Laird at the UC Davis Vascular Center in Davis, California. “The device tracked easily through tortuous anatomy and over my workhorse .035 guidewire. The device brings the functionality of a support catheter with the added benefit of knowing I can cross tough lesions by extending the bevel tip if need be. I’m very excited with the added capabilities that these crossing catheters bring to my lab while still being cost-effective and saving me considerable time during the procedure.”

Dr. Mahmood Razavi at St. Joseph Heart & Vascular Center in Orange, California stated, “My initial experience with the Wingman35 went very well. It offered me great support and compatibility with my wires while allowing me to cross a previously attempted ISR that was unsuccessful. The time savings on that case, in particular, gave me the opportunity to treat more patients that day.”

Company comments

ReFlow Medical President and CEO, Isa Rizk, commented, “The Wingman35 represents an important addition to the Wingman product line, soon to be followed by additional portfolio products. We look forward to continuing to provide the physicians with a full toolbox that helps them more easily address their daily clinical needs.”

Source: ReFlow Medical Corporation., Business Wire

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