AngioSafe emerges from stealth with FDA clearance for Santreva-ATK catheter
AngioSafe announced it has received FDA 510(k) clearance and CE marking for its Santreva-ATK endovascular […]
AngioSafe announced it has received FDA 510(k) clearance and CE marking for its Santreva-ATK endovascular revascularization catheter.
San Jose, California-based AngioSafe designed the device for wire-free intraluminal crossing of chronic total occlusions (CTOs) while simultaneously compressing plaque and recanalizing vessels. Santreva-ATK enables vessel preparation for imaging and treatment in a single step without an external power source.
The catheter is now commercially available in Europe and is expected to launch in the U.S. next month.
See full article (https://www.massdevice.com/angiosafe-emerges-from-stealth-with-fda-clearance-for-santreva-atk-catheter/)