www.fdanews.com/articles/196148-reflow-earns-expanded-fda-clearance-for-crossing-catheter
Reflow Earns Expanded FDA Clearance for Crossing Catheter
March 6, 2020
Reflow Medical has received expanded 510(k) clearance for its Wingman crossing catheter, a device that enables physicians to cross chronic total occlusions (CTOs) in peripheral lesions.
The device uses an extendable beveled tip to create a channel that helps penetrate a completely obstructed coronary artery with a guidewire, allowing the lesion to be worked upon with other devices.
The crossing catheter showed a 90 percent crossing rate in its clinical trial, meeting its primary safety and efficacy endpoints.