ReFlow Medical Earns CE Mark for Two Catheter Devices

San Clemente, Calif.-based ReFlow Medical Inc. has earned CE mark approval for its Wingman35 crossing catheter and Spex shapeable support catheter, both of which were first used by Andrej Schmidt, M.D., at University Leipzig, Germany. The CE mark allows the use of both devices in peripheral vasculature. The Wingman35 crossing catheter allows the physician to use their .035 inch guide wire of choice during procedures, and the new Spex shapeable support catheter has a shapeable tip option designed to meet 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 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 [older] 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.”

“The addition of these new devices expands on our current .014 inch offering and builds a broad suite of products that give the physicians more options when treating a wide variety of lesions,” said CEO Isa Rizk. “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.”

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

The company makes devices to treat cardiovascular disease.