Enrollment Completed in the Wing-IT IDE CTO Clinical Trial
April 10, 2019—Reflow Medical, Inc. has announced the completion of enrollment in its Wing-IT investigational device exemption (IDE) trial. Wing-IT is a prospective, multicenter, nonrandomized study evaluating the ability of the company's Wingman catheter to cross chronic total occlusions (CTOs) in peripheral lesions after failed guidewire attempts.
Reflow Medical advised that 85 patients with advanced peripheral artery disease were enrolled in the Wing-IT trial and evaluated at 12 centers in the United States, Germany, and Austria. John R. Laird, MD, of Adventist Heart and Vascular Institute in St. Helena, California, serves as the Principal Investigator for the study.
In the company's announcement, Dr. Laird commented, “We would like to express our gratitude to the participating patients, physician investigators, research staff, and employees. Their efforts have made it possible for us to reach this major milestone.”
The Wingman crossing catheter uses an extendable beveled tip that creates a channel to help cross the occlusion, enabling further treatment of the lesion with therapeutic devices.