The first patients have been enrolled in a prospective, multicentre, non-randomised study intended to evaluate the ability of the Reflow Wingman Catheter (Reflow Medical) to cross chronic total occlusions (CTOs) in peripheral lesions.
Initial patient enrolments were performed by Nilesh Goswami, Prairie Cardiovascular at HSHS St. John’s Hospital Prairie Heart Institute, Springfield, USA, and S Jay Mathews, Bradenton Cardiology Center in Bradenton, USA.
The Wing-IT IDE clinical trial is a non-randomised study evaluating the use of the Reflow Medical Wingman Catheter to cross chronic total occlusions in infrainguinal peripheral arteries, the company states.
The trial is expected to enrol 85 patients at up to 13 centres in the USA and Europe. The principal investigator for the study is John Laird, Adventist Heart and Vascular Institute, St Helena, USA.
“Patients with advanced peripheral artery disease (PAD) frequently develop CTOs, which can be difficult to treat with endovascular therapy,” says Laird. “The ability to cross CTOs 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.