ReFlow Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its Wingman35 Crossing Catheter for use in the peripheral vasculature.
The catheter has been developed for use in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature.
ReFlow Medical president and CEO Isa Rizk said: "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."
The catheter was first used by Dr John Laird at the UC Davis Vascular Center and Dr. Mahmood Razavi at St. Joseph Heart & Vascular Center, both located in California.
Dr Laird said: "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."
ReFlow Medical develops cost-effective technologies for cardiovascular disease.