Reflow Medical said yesterday it launched a clinical study of its Reflow Wingman catheters exploring the device’s ability to cross chronic total occlusions in peripheral lesions.
The first patients in the study, dubbed the Wing-It trial, have already been enrolled, the San Clemente, Calif.-based company said. Enrollments took place at Springfield, Ill.’s St. John’s Hospital Prairie by Dr. Nilesh Goswami and at Bradenton, Fla.’s Bradenton Cardiology Center by Dr. S. Mathews.
“Reflow is excited to be conducting this study to support expanded treatment options for physicians,” CEO Isa Rizk said in a press release.
The Wing-It trial is slated to enroll 85 patients at up to 13 centers across the US and Europe, with Dr. John Laird of St. Helena, Calif.’s Adventist Heart and Vascular Institute acting as principal investigator.
“Patients with advanced peripheral artery disease frequently develop CTOs, which can be difficult to treat with endovascular therapy. 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,” Dr. Laird said in a prepared statement.
Last September, Reflow Medical said it won 510(k) clearance from the FDA for a new indication for its Wingman14C crossing catheter in treating blocked coronary arteries.
