FDA Clears Santreva-ATK for Patients with Peripheral Artery Disease, With Subhash Banerjee, MD

On September 29, 2025, parent company AngioSafe revealed multiple clinical milestones achieved by its Santreva-ATK Endovascular Revascularization Catheter, including 510(k) clearance from the US Food and Drug Administration (FDA) and CE mark approval in Europe.1

Santreva-ATK is the first wire-free, external power-free, intraplaque chronic total occlusion (CTO) crossing and 1-step vessel preparation platform for femoropopliteal arteries. The device is intended for use in patients with peripheral artery disease (PAD) exhibiting CTOs, which are encountered up to 50% of the time in patients with symptomatic PAD. These lesions are a leading cause of failed interventions, prolonged procedure times, and adverse events. Current tools for managing CTOs are limited, leaving clinicians with relatively few methods of treatment.1

These approvals are a product of positive results from the RESTOR-1 clinical trial, which investigated the device’s efficacy in treating patients with CTOs in PAD. Santreva-ATK successfully crossed CTOs in 90% of participants, compressing plaque and recanalizing CTOs to prepare vessels for further imaging and final treatment.1

The editorial team at HCPLive sat down with lead investigator Subhash Banerjee, MD, an interventional cardiologist with Baylor Scott & White, to discuss the implications of this new technology and how it will relieve the burden of this underserved patient population.

“In this study, which is very unique to any study done before in the CTO space in PAD, we were not only studying whether we crossed the blockage successfully, but also how we crossed,” Banerjee told HCPLive. “Did we cross through the center of the plaque or the body of the blockage? In doing so, did we damage or tear the walls of the blood vessel that we are crossing?”

RESTOR-1 was a prospective, multi-center, pivotal study conducted across 14 sites in the US. For inclusion, patients had to be ≥22 years of age, have PAD of category 2-5 as defined by Rutherford Clinical Classification, and have PAD in the target extremity confirmed via imaging and/or magnetic resonance angiography (MRA). Patients were excluded if they exhibited systemic infection or an infection in the same extremity as the target lesion, if the lesion was within a native vein, synthetic vessel grafts, or stent occlusion, or if the patient had plans for an intervention in the contralateral limb or target limb during the study, among other conditions.2

A total of 133 patients were ultimately enrolled in the trial; each participant was treated with Santreva-ATK, which facilitated the intraluminal placement of guidewires beyond CTOs in the peripheral vasculature. Outcome measures included the ability of the catheter to place the guidewire in the absence of device-related major adverse events through discharge or 24 hours post-operation, whichever came first.2

Investigators found a mean CTO crossing time of 25 minutes between all patients, with a median of 9 minutes. The trial exhibited a 90% success rate with a mean Lumen gain of >55%. Investigators recorded no device-related MAEs or embolization, as well as no major perforations, flow-limiting dissections, or bailout stents. Significant improvements in Rutherford Classification and pain scores were also recorded.2

“The implications can be very profound,” Banerjee said. “The greatest contribution of this technology, in my view, would be to democratize peripheral CTO procedures. 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.”

According to a press release from AngioSafe, Santreva-ATK is planned to launch in the US in October of 2025. Highlights from the RESTOR-1 results was presented at the Amputation Prevention Symposium Europe Congress on October 14, 2025.1

Editor's Note: Banerjee reports disclosures with AngioSafe, Esperion, GE Healthcare, Kaneka, Teleflex, Ca

References

1. AngioSafe Unveils Atheroplasty Innovation Following DA 501(k) Clearance, CE Mark Approval, and First Real-World Procedures with Santreva-ATK Endovascular Revascularization Catheter. September 29, 2025. Accessed October 16, 2025. https://www.angiosafe.com/press-releases/angiosafe-unveils-atheroplasty-innovation-following-fda-510k-clearance-ce-mark-approval-and-first-real-world-procedures-with-santreva-atk-endovascular-revascularization-catheter/

2. AngioSafe, Inc. AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study) (RESTOR-1). ClinicalTrials.gov identifier: NCT04663867. Updated November 4, 2024. Accessed October 16, 2025. https://www.clinicaltrials.gov/study/NCT04663867