FDA Clears AngioSafe’s Santreva-ATK Endovascular Revascularization Catheter

AngioSafe has emerged from stealth with U.S. Food and Drug Administration (FDA) 510(k) clearance for its flagship product, the Santreva-ATK Endovascular Revascularization Catheter, enabled by its proprietary atheroplasty technology platform. Santreva-ATK received CE marking this past summer and was successfully used in the first real-world patient procedures in Italy in September.

The device is intended for wire-free intraluminal peripheral CTO crossing and is designed for simultaneous plaque compression and CTO recanalization to prepare vessels for further imaging and final treatment in a single step without using an external power source. Santreva-ATK is now commercially available in Europe and the United States.

Santreva-ATK is designed to make complex interventions safer, simpler, faster, and more predictable, thereby helping physicians safely and confidently treat patients suffering from peripheral artery disease (PAD), especially those with the most occlusive disease, such as severe stenosis, including CTOs.

“AngioSafe was founded with a vision to restore blood flow safely, simply and reliably for patients with difficult-to-treat complex lesions by physicians with all experience levels,” AngioSafe Co-Founder/President/CEO Sarvajna Dwivedi, Ph.D., said. “Our U.S. and EU regulatory clearances, first real-world patient procedures, and emergence from stealth show that our vision is now becoming a reality. We look forward to advancing our mission and delivering lasting impact for patients, physicians, and the field of complex interventions, starting with Santreva-ATK as the first offering from our pipeline.”

The first real-world cases with Santreva-ATK were performed at Policlinico Abano in Italy by Marco Manzi, M.D., a lifetime achievement award-winning interventional radiologist, marking the culmination of more than a decade of technology refinement and clinical research. “Crossing a CTO is often one of the most difficult and risky steps of a procedure,” Dr. Manzi stated. “With Santreva-ATK, we were able to cross without a wire and prepare the patient’s vessel safely and efficiently in a single step. This innovation has the perfect combination of attributes with a potential to simplify some of the most challenging cases and expand treatment options for patients.”

CTOs are encountered as often as up to 50% of the time in patients with symptomatic PAD¹ and remain a leading cause of failed interventions, prolonged procedure times, and adverse events. Despite decades of innovation, existing tools for crossing and preparing severely blocked vessels often leave physicians with limited, risky options, and complex algorithms. Santreva-ATK, enabled by atheroplasty technology, addresses these challenges by simultaneously combining mechanisms and features designed for intraplaque traversal with axial plaque disruption, lateral plaque compression, and channel formation to revascularize severely occluded arteries.

FDA clearance and CE marking were supported by data from the RESTOR-1 pivotal study, which evaluated the safety and effectiveness of AngioSafe’s peripheral CTO crossing system. In subjects with totally occluded femoropopliteal arteries (n=70, per protocol), Santreva-ATK demonstrated 90% overall success and no device-related major adverse events (MAEs) such as flow-limiting dissection, major perforation and distal vessel embolization.² In a subset of RESTOR-1 subjects (n=54), post-hoc quantitative secondary analysis of angiography and intravascular ultrasound (IVUS) imaging data suggests that Santreva-ATK may provide >55% mean lumen gain in femoropopliteal arteries.³

“For a long time, CTOs have required safe and simple algorithms to help interventionalists focus on relieving ischemia,” said Subhash Banerjee, M.D., chief of cardiovascular research and innovation for Baylor Scott & White Heart and Vascular Hospital and principal RESTOR-1 study investigator. “Santreva-ATK’s attributes and outcomes enable this goal, while reducing the complexity of endovascular interventions in femoropopliteal arteries.”

The first cases completed in Dr. Manzi’s lab were in collaboration with Gada Italia, AngioSafe’s distribution partner in Italy.

AngioSafe develops technologies that safely, efficiently, and predictably empower interventionalists to tackle complex lesions. Its proprietary atheroplasty core technology platform does not require any capital equipment and simultaneously combines mechanisms and features to revascularize severely occluded arteries, simplifying one of the most complex procedures in cardiovascular interventions. With its flagship Santreva-ATK endovascular revascularization catheter, AngioSafe is advancing a new era of vascular innovation to improve procedure outcomes and confidence for physicians addressing complex femoropopliteal interventions.

References
¹ Banerjee, S. et al. Comparative Assessment of Procedure Cost and Outcomes Between Guidewire and Crossing Device Strategies to Cross Peripheral Artery Chronic Total Occlusions. JACC: Cardio Interv. 2016; 9(21).
² RESTOR-1 Pivotal Clinical Study data on file and in the Instructions for Use (IFU)
³ Post-hoc analysis of prospectively collected data, as assessed by the core lab and study team: data on file with company