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ReFlow Medical obtains CE mark approval for Wingman35 and SpeX devices

ReFlow Medical has received CE mark approval for its Wingman35 Crossing Catheter and speX Shapeable Support Catheter to use in peripheral vasculature.

Clinically, the devices have been first used by Dr Andrej at University Leipzig, Germany.

Dr Schmidt said: "Building on the Wingman14 design, the addition of the Wingman35 to the portfolio now expands the choice of wire I can use when treating my patients."

The new Wingman35 Crossing Catheter helps physicians to use their .035 guidewire of choice during procedures, while speX Shapeable Support Catheter provides them with a shapeable tip option to meet specific case needs.

ReFlow Medical president and CEO Isa Rizk said the addition of new devices expands on current .014 offering and builds a broad suite of products that give the physicians more options when treating a wide variety of lesions.

"We look forward to continue to change the rules for vascular access by introducing additional products in the near term that meet the need for simple, yet effective solutions," Rizk added.

The company also submitted applications to the US Food and Drug Administration for 510(k) approval of both devices. Currently, these are under review.