AngioSafe's Santreva-ATK Receives FDA Clearance for Peripheral Artery Disease Treatment
核心洞察
AngioSafe (搜索)'s Santreva-ATK (搜索) Endovascular Revascularization Catheter received FDA 510(k) clearance and CE mark approval for treating chronic total occlusions in peripheral artery disease (搜索) patients.
The RESTOR-1 pivotal study demonstrated 90% success rate in crossing CTOs with no device-related major adverse events across 133 enrolled patients.
The wire-free, external power-free device represents the first platform designed for simultaneous plaque compression and recanalization in femoropopliteal arteries (搜索).
AngioSafe (搜索) announced on September 29, 2025, that its Santreva-ATK (搜索) Endovascular Revascularization Catheter has received 510(k) clearance from the US Food and Drug Administration and CE mark approval in Europe. The device represents the first wire-free, external power-free, intraplaque chronic total occlusion (搜索) (CTO) crossing and 1-step vessel preparation platform specifically designed for femoropopliteal arteries (搜索) in patients with peripheral artery disease (搜索).
Addressing Critical Unmet Need in PAD Treatment
CTOs are encountered in up to 50% of patients with symptomatic peripheral artery disease (搜索) and remain a leading cause of failed interventions, prolonged procedure times, and adverse events. Current tools for managing CTOs are limited, leaving clinicians with relatively few treatment methods for these challenging lesions.
"Crossing a CTO is often one of the most difficult and risky steps of a procedure," said Marco Manzi, MD, an interventional radiologist at Policlinico Abano in Italy, who performed the first real-world cases with Santreva-ATK (搜索). "With Santreva-ATK, we were able to cross without a wire and prepare the patient's vessel safely and efficiently in a single step."
RESTOR-1 Study Demonstrates Strong Efficacy and Safety Profile
The regulatory approvals were supported by data from the RESTOR-1 pivotal study, a prospective, multi-center trial conducted across 14 sites in the US. The study enrolled 133 patients aged 22 years or older with PAD of category 2-5 as defined by Rutherford Clinical Classification, with PAD in the target extremity confirmed via imaging and/or magnetic resonance angiography.
In the per-protocol analysis of subjects with totally occluded femoropopliteal arteries (搜索) (n=70), Santreva-ATK (搜索) demonstrated a 90% overall success rate with no device-related major adverse events such as flow-limiting dissection, major perforation, and distal vessel embolization. The mean CTO crossing time was 25 minutes across all patients, with a median of 9 minutes.
Post-hoc quantitative secondary analysis of angiography and intravascular ultrasound imaging data in a subset of RESTOR-1 subjects (n=54) suggests that Santreva-ATK (搜索) may provide greater than 55% mean lumen gain in femoropopliteal arteries (搜索). The trial also recorded significant improvements in Rutherford Classification and pain scores.
Technology Platform and Clinical Impact
Santreva-ATK (搜索) is enabled by AngioSafe (搜索)'s proprietary Atheroplasty technology platform, which simultaneously combines mechanisms designed for intraplaque traversal with axial plaque disruption, lateral plaque compression, and channel formation to revascularize severely occluded arteries. The device is intended for wire-free intraluminal peripheral CTO crossing and simultaneous plaque compression and recanalization of CTOs to prepare vessels for further imaging and final treatment.
"The greatest contribution of this technology, in my view, would be to democratize peripheral CTO procedures," said Subhash Banerjee, MD, chief of cardiovascular research and innovation for Baylor Scott & White (搜索) Heart and Vascular Hospital and principal investigator of the RESTOR-1 study. "That means operators at various stages in their lives or careers can take on these procedures and help more patients because of a combination of higher success and, importantly, not causing any major serious complications in the patients."
Commercial Availability and Market Launch
Santreva-ATK (搜索) is now commercially available in Europe and is planned to launch in the US in October 2025. The device received CE marking in July 2025 and was successfully used in the first real-world patient procedures in Italy earlier this month, performed in collaboration with Gada Italia, AngioSafe (搜索)'s distribution partner in Italy.
"AngioSafe (搜索) 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," said Sarvajna Dwivedi, PhD, co-founder, president and CEO of AngioSafe. "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."
Data highlights from RESTOR-1 were presented at the Amputation Prevention Symposium Europe Congress on October 14, 2025.