AngioSafe’s Santreva-ATK Endovascular Revascularization Catheter Cleared by FDA

October 2, 2025—AngioSafe announced the company’s emergence from stealth with the FDA 510(k) clearance of its flagship product, the Santreva-ATK endovascular revascularization catheter, which is enabled by its atheroplasty technology platform for the treatment of peripheral artery disease.

Additionally, the Santreva-ATK received CE Mark approval in July 2025. It is now commercially available in Europe and will be available in the United States in October, advised AngioSafe.

According to the company, the device is intended for wire-free intraluminal crossing of peripheral chronic total occlusions (CTOs). It is designed for simultaneous plaque compression and recanalization of CTOs to prepare vessels for further imaging and final treatment in a single step without use of an external power source.

In September, the Santreva-ATK was successfully used in the first real-world patient procedures, which were performed by Marco Manzi, MD, at Policlinico Abano in Abano Terme, Italy, noted the company.

AngioSafe stated that FDA clearance and CE Mark approval of the Santreva-ATK peripheral CTO crossing system were supported by data from the RESTOR-1 pivotal study, which evaluated the safety and effectiveness of the device. In patients with totally occluded femoropopliteal arteries (n = 70, per protocol), Santreva-ATK demonstrated 90% overall success and no device-related major adverse events, such as flow-limiting dissection, major perforation, or distal vessel embolization.

In a subset of RESTOR-1 patients (n = 54), post-hoc quantitative secondary analysis of angiography and intravascular ultrasound imaging data suggested that Santreva-ATK may provide > 55% mean lumen gain in femoropopliteal arteries, stated the company.

The Principal Investigator of the RESTOR-1 study is Subhash Banerjee, MD, who is Chief of Cardiovascular Research and Innovation for Baylor Scott & White Heart and Vascular Hospital in Dallas, Texas. On October 14, 2025, Dr. Banerjee will present data highlights from RESTOR-1 at AMP Europe, the Amputation Prevention Symposium in Amsterdam, the Netherlands, noted AngioSafe.