Wing-IT Trial Begins for Reflow Medical's Wingman Catheters to Treat Peripheral CTO Lesions
March 13, 2018—Reflow Medical, Inc. announced the start of enrollment in its prospective multicenter nonrandomized study evaluating the ability of the Wingman catheters to cross chronic total occlusions (CTOs) in peripheral lesions. The Wing-IT investigational device exemption trial is expected to enroll 85 patients at up to 13 centers in the United States and Europe.
According to the company, the initial patient enrollments were performed by Nilesh Goswami, MD, of Prairie Cardiovascular at HSHS St. John's Hospital Prairie Heart Institute in Springfield, Illinois, and S. Jay Mathews, MD, of Bradenton Cardiology Center in Bradenton, Florida.
The principal investigator for the study is John Laird, MD, of Adventist Heart and Vascular Institute in St. Helena, California. In the company's announcement, Dr. Laird commented, "Patients with advanced peripheral artery disease frequently develop CTOs, which can be difficult to treat with endovascular therapy. The ability to cross CTOs is directly related to acute procedural success and favorable long-term outcomes, including preventing the need for either bypass surgery or amputation."