FDA Clears ReFlow Medical's Wingman35 Crossing Catheter

October 23, 2014—ReFlow Medical, Inc. announced US Food and Drug Administration (FDA) marketing clearance of the company’s Wingman35 crossing catheter. 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. 

Additionally, the company announced that the first cases with the device in the United States were performed by John R. Laird, MD, at the University of California Davis Vascular Center in Davis, California, and Mahmood Razavi, MD, at St. Joseph Heart & Vascular Center in Orange, California. 

In the company’s press release, Dr. Laird commented, “My first clinical cases with the Wingman35 were impressive and consistent with my prior experience with the Wingman14. The device tracked easily through tortuous anatomy and over my workhorse 0.035-inch 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. Razavi added, “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 (in-stent restenosis) that was unsuccessful. The time savings on that case, in particular, gave me the opportunity to treat more patients that day.”

In September, the company announced European CE Mark approval and the initial clinical use of the Wingman35 crossing catheter as well as the Spex shapeable support catheter for use in the peripheral vasculature.