ReFlow Medical said physicians in Germany are already using its Wingman35 and Spex crossing catheters, after the San Clemente, Calif.-based company won CE Mark approval for both devices for treating lesions in the peripheral vasculature.
ReFlow Medical’s Wingman35 extensible tip catheter is designed to gently create a passage to help guidewires cross obstructions in blood vessels. The speX catheter can be shaped to allow physicians to achieve a preferred angle during a procedure, according to a press release.
ReFlow won 510(k) clearance from the FDA in 2012 for a smaller-diameter version of the Wingman catheter. Yesterday the company said it’s also seeking clearance for the newer crossing catheters from the watchdog agency.
"The addition of these new devices expands on our current .014" offering and builds a broad suite of products that give the physicians more options when treating a wide variety of lesions," CEO Isa Rizk said in prepared remarks.