FDA Clears ReFlow Crossing Catheter

San Clemente, Calif.-based ReFlow Medical Inc. has earned U.S Food and Drug Administration (FDA) 510(k) clearance for U.S. commercialization of its Wingman35 crossing catheter for use in the peripheral vasculature.

The initial U.S. cases were performed by John R. Laird, M.D., at the University of California Davis Vascular Center, and Mahmood Razavi, M.D., at St. Joseph Heart & Vascular Center in Orange, Calif. The Wingman35 crossing catheter is indicated for use with steerable guidewires to access discrete regions of the peripheral vasculature and enable rapid, routine, off-the-shelf lesion crossing.

“My first clinical cases with the Wingman35 were impressive and consistent with my prior experience with the Wingman14,” said Laird. “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.”

“My initial experience with the Wingman35 went very well,” said Razavi stated. “It offered me great support and compatibility with my wires while allowing me to cross a previously attempted in-stent restenosis that was unsuccessful. The time savings on that case, in particular, gave me the opportunity to treat more patients that day.”

ReFlow Medical makes technologies for cardiovascular disease.