Reflow Medical has announced the completion of enrolment in its Wing-IT investigational device exemption (IDE) trial; a prospective, multicentre, nonrandomised study evaluating the ability of the Wingman catheter to cross chronic total occlusions (CTOs) in peripheral lesions after failed guidewire attempts.
Eighty-five patients with advanced peripheral artery disease enrolled in the Wing-IT trial were evaluated at 12 centre in the USA, Germany, and Austria. John R Laird of Adventist Heart and Vascular Institute, St. Helena, USA, is the principal investigator for the study.
“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,” says Laird.
The Wingman Crossing Catheter uses an extendable beveled tip that creates a channel to help penetrate, or cross, the occlusion. This enables further treatment of the lesion with therapeutic devices.
Isa Rizk, chief executive officer of Reflow Medical, commented, “Our goal is to expand the physician’s ability to treat CTOs, which often develop in patients with advanced peripheral arterial disease. Facilitating CTO crossings helps physicians avoid amputations or bypass surgery, which directly correlates to better long-term outcomes.”