Reflow Medical recently announced that it received FDA clearance for expanded indication of its Wingman Crossing Catheter.
The Wingman Catheter is designed to cross peripheral CTOs using an extendable beveled tip that creates a channel to help penetrate or cross the occlusion was a guidewire. Reflow Medical received expanded indication for the device following a successful clinical trial that demonstrated a 90% cross-rate when up to two previous guide wires could not cross challenging lesions.
“With this expanded indication, physicians gain the ability to cross (CTOs) in peripheral lesions with a simple and very effective device,” Dr. John Laird, principal investigator on the study and a doctor at Adventist Heart and Vascular Institute in St. Helena, Calif., said in a news release.
“We are extremely grateful to the physician investigators, patients, research staff and employees who helped us conduct this very important and compelling clinical study that supported this expanded treatment option for crossing peripheral CTOs.”
