ReFlow Medical announces CE mark for Wingman35 and SpeX catheters

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ReFlow Medical has announced the initial clinical use of their Wingman35 crossing catheter and speX shapeable support catheter by Andrej Schmidt, Park Hospital Leipzig, Germany. The devices were recently granted CE mark approval for use in the peripheral vasculature. 

The company has submitted applications to the US Food and Drug Administration for 510(k) clearance of both devices, which are currently under review.

The new Wingman35 allows the physician to use their .035″ guidewire of choice during procedures, and the new speX provides physicians with a shapeable tip option to meet their specific case needs.

“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,” said Schmidt.  “The unique extendable bevel tip gives me the ability to utilise the Wingman as a daily support catheter with the added benefit of crossing lesions when needed. The speX shapeable catheter further expands my capabilities with the Wingman14 device because it retains its shape and allows me to reshape as needed. I can rapidly adjust to the specific needs of each case and each patient, with predictable results.”

ReFlow Medical president and CEO, Isa Rizk, commented, “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. We are thankful for the input from our scientific advisory board, we worked closely with them to develop these products. We look forward to changing the rules for vascular access with additional products in the near term that continue to meet the need for simple but effective solutions.”