Santreva™-ATK Endovascular Revasculariztion Catheter

The Santreva™-ATK Endovascular Revascularization Catheter is a percutaneous catheter designed to facilitate guidewire placement beyond stenotic lesions and chronic total occlusions (CTOs) in femoropopliteal arteries. It works by using a rotating distal tip with an integrated cutting loop to puncture, displace, and compress plaque simultaneously, while a three-wing centering system maintains intraluminal/intraplaque position and creates an angiographically visible channel for subsequent intervention.

The Santreva-ATK features a larger profile atraumatic tip (1.35 mm distal tip, 2.4 mm centering system) with integrated cutting loop and manual torque wheel control, compared to the predicate FRONTRUNNER's smaller blunt-dissection tip (1.0 mm) and lever-operated jaw design. Santreva-ATK has a 135 cm working length (vs. predicate's 90–140 cm), uses electron beam sterilization (vs. EtO), and includes a centering wing system unique to this design, though both are single-use percutaneous catheters classified as Class II.

ISO 10993-1 Biological evaluation of medical devices – Part 1 was used for biocompatibility testing, including cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, hemocompatibility, and thrombogenicity assessments.

The Santreva-ATK and FRONTRUNNER CTO Catheter share the same intended use (facilitating guidewire placement across peripheral CTOs), target population (adult PAD patients), regulatory classification (Class II percutaneous catheter), and single-use application. Despite design differences in tip profile and mechanism (cutting loop with compression vs. microblunt dissection), nonclinical testing (tensile, torque, flexibility, pushability, corrosion), GLP animal studies showing comparable handling and safety to the predicate, and the RESTOR-1 pivotal clinical trial demonstrating 87.8% clinical success with no device-related major adverse events establish that the Santreva-ATK does not raise different safety or effectiveness questions and is therefore substantially equivalent.