On the heels of CE Mark approval in Europe, ReFlow Medical announced FDA clearance for its Wingman35 crossing catheter and said it has already been used in California vascular clinics.
The device, which consists of a support catheter with a concealed, beveled guide-tip and activating handle, is designed to cross tough lesions inside blood vessels by extending a bevel tip, according to an FDA filing. San Clemente, Calif.-based ReFlow last month won CE Mark approval in the European Union for the Wingman35 and for its Spex device.
Patients have undergone procedures with the device at UC Davis Vascular Center and at St. Joseph Heart & Vascular Center in Orange, Calif.
Two years ago, ReFlow won FDA 510(k) clearance for a smaller-diameter version of the Wingman catheter.
"The Wingman35 represents an important addition to the Wingman product line, soon to be followed by additional portfolio products," CEO Isa Rizk said in prepared remarks.