Reflow Medical Inc., a developer of innovative medical devices to combat cardiovascular disease, announced that the first patients have been enrolled in a prospective, multi-center, non-randomized study intended to evaluate the ability of the Reflow Wingman Catheters to cross chronic total occlusions (CTOs) in peripheral lesions.
Initial patient enrollments were performed by Nilesh Goswami, MD, of Prairie Cardiovascular at HSHS St. John’s Hospital Prairie Heart Institute, Springfield, Illinois, and S. Jay Mathews, MD, of Bradenton Cardiology Center in Bradenton, Florida. The Wing-IT trial is expected to enroll 85 patients at up to 13 centers in the US and Europe. The principal investigator for the study is John Laird, MD, of Adventist Heart and Vascular Institute, St. Helena, California.
Dr. Laird commented, “Patients with advanced peripheral artery disease frequently develop CTOs, which can be difficult to treat with endovascular therapy.” He notes, “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.”
“Reflow is excited to be conducting this study to support expanded treatment options for physicians,” concluded Isa Rizk, CEO of Reflow Medical.