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Reflow Medical recruits first patients in Wing-IT IDE clinical trial

Reflow Medical, a developer of innovative medical devices to combat cardiovascular disease, has recruited first patients in a prospective, multi-center and non-randomized study intended to evaluate the ability of the 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.

"Patients with advanced peripheral artery disease (PAD) frequently develop CTOs, which can be difficult to treat with endovascular therapy," says Dr. Laird.

"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 Medical CEO Isa Rizk said: “Reflow is excited to be conducting this study to support expanded treatment options for physicians.”

Reflow Medical is a private company focused on empowering physicians through the design and development of innovative and cost-effective technologies for cardiovascular disease. Reflow is developing a family of products to treat the peripheral and coronary vasculature.