Reflow Medical announced that the first patients have been enrolled in a prospective, multicentre, non-randomised study intended to evaluate the ability of the Reflow Wingman catheters to cross chronic total occlusions in peripheral lesions.
The Wing-IT study is a non-randomised study evaluating the safety and effectiveness of the Wingman catheter to cross chronic total occlusions in infrainguinal peripheral arteries.
Initial patient enrolments were performed by Nilesh Goswami of Prairie Cardiovascular at HSHS St. John’s Hospital Prairie Heart Institute, Springfield, USA and S Jay Mathews of Bradenton Cardiology Center in Bradenton, USA. The Wing-IT trial is expected to enroll 85 patients at up to 13 centres in the US and Europe. The principal investigator for the study is John Laird of Adventist Heart and Vascular Institute, St. Helena, USA.
“Patients with advanced peripheral artery disease frequently develop chronic total occlusions, which can be difficult to treat with endovascular therapy,” says Laird. “The ability to cross chronic total occlusions is directly related to acute procedural success and favourable 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,” states Isa Rizk, CEO of Reflow Medical.