AngioSafe Emerges from stealth with FDA Clearance for novel endovascular catheter

AngioSafe receives FDA Clearance for novel endovascular catheter: @Yodiyim - stock.adobe.com

AngioSafe has emerged from stealth mode with U.S. Food and Drug Administration 510(k) clearance for its flagship Santreva-ATK Endovascular Revascularization Catheter, the company announced. The device also received CE marking in July and was successfully used earlier this month in first real-world procedures in Italy.

Enabled by AngioSafe’s proprietary Atheroplasty platform, the Santreva-ATK is intended for wire-free intraluminal crossing of peripheral chronic total occlusions. The catheter is designed to compress plaque and re-establish blood flow in a single step, preparing vessels for imaging and treatment without the need for an external power source.

The device is commercially available in Europe and will launch in the U.S. next month.

“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,” said Sarvajna Dwivedi, Ph.D., co-founder, president and CEO of AngioSafe. “Our US and EU regulatory clearances, first real-world patient procedures, and emergence from stealth show that our vision is now becoming a reality.”

The first patient cases with Santreva-ATK were completed at Policlinico Abano in Italy by interventional radiologist Marco Manzi, M.D., who praised the device for its ability to cross CTOs without a wire. “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,” Manzi said.

CTOs occur in up to half of patients with symptomatic peripheral artery disease and are a leading cause of failed interventions, longer procedures, and complications. Existing tools often force physicians into complex and risky treatment paths. AngioSafe’s device integrates multiple mechanisms—plaque traversal, disruption, compression, and channel formation—into one system designed to streamline revascularization.

Clinical data from the RESTOR-1 Pivotal Study supported regulatory clearances. In patients with occluded femoropopliteal arteries (n=70, per protocol), Santreva-ATK achieved 90% overall success with no device-related major adverse events. A secondary analysis suggested the catheter provided more than 55% mean lumen gain.

Advances in endovascular innovation

The clearance of AngioSafe’s catheter reflects a broader wave of innovation in endovascular therapy, where developers are tackling the long-standing challenges of treating peripheral artery disease and chronic total occlusions. CTOs have traditionally been among the most complex obstacles in interventional cardiology and vascular surgery, often requiring lengthy procedures, advanced technical skill, and multiple devices.

Recent advancements are trending toward simplifying these procedures by integrating steps that were once performed separately. Novel catheter platforms now focus on combining lesion crossing, plaque modification, and vessel preparation into streamlined systems. This integration is designed to reduce procedure time, minimize the need for multiple device exchanges, and lower the risks associated with prolonged interventions.

Another area of progress lies in the movement away from dependence on external power sources. Devices that rely on mechanical design rather than energy delivery aim to improve predictability and safety while widening access for physicians with varying levels of experience. This trend is especially significant for treating PAD, where access to advanced interventions can be limited by geography and training resources.

Clinical trial design is also evolving to better capture real-world outcomes. Beyond measuring technical success rates, studies increasingly focus on lumen gain, patient safety, and long-term durability. Imaging techniques such as intravascular ultrasound (IVUS) are being used more often to quantify vessel remodeling and validate device performance.

Taken together, these advancements reflect a growing emphasis on simplifying complex procedures, expanding access to advanced care, and reducing the learning curve for physicians. As regulatory clearances and European adoptions signal clinical acceptance, the field is likely to see more technologies aimed at transforming treatment algorithms for CTOs and PAD.