News | October 02, 2014

ReFlow Gains CE Mark, Initial Clinical Use of the Wingman35 Crossing Catheter and SpeX Shapeable Support Catheter

ReFlow CE Mark Wingman35 Crossing Catheter SpeX Shapeable Support Catheter

October 2, 2014 — ReFlow Medical Inc. announced the initial clinical use of its Wingman35 Crossing Catheter and speX Shapeable Support Catheter by Dr. Andrej Schmidt at University Leipzig, Germany. The devices were recently granted European Union CE mark approval for use in the peripheral vasculature. The new Wingman35 Crossing Catheter allows the physician to use their 0.035-inch guidewire of choice during procedures, and the new speX Shapeable Support Catheter 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,” Schmidt said. “The unique extendable bevel tip gives me the ability to utilize 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 0.014-inch 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 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.”

ReFlow Medical has submitted applications to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of both devices, which are currently under review.

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