ReFlow Medical's Wingman35 and Spex Catheters Receive CE Mark Approval

September 25, 2014—ReFlow Medical, Inc. announced the recent European CE Mark approval and the initial clinical use of the company’s Wingman35 crossing catheter and Spex shapeable support catheter for use in the peripheral vasculature. ReFlow Medical has submitted applications to the US Food and Drug Administration for 510(k) clearance of both devices that are currently under review.

The Wingman35 crossing catheter allows physicians to use a 0.035-inch guidewire of choice during procedures, and the new Spex shapeable support catheter provides physicians with a shapeable tip option to meet specific case needs.

Andrej Schmidt, MD, of University Leipzig in Leipzig, Germany, conducted the first procedures with the new device. In ReFlow Medical’s press release, Dr. Schmidt commented, “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 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.”