AngioSafe announced it has received FDA 510(k) clearance and CE marking for its Santreva-ATK endovascular revascularization catheter.
San Jose, California-based AngioSafe designed the device for wire-free intraluminal crossing of chronic total occlusions (CTOs) while simultaneously compressing plaque and recanalizing vessels. Santreva-ATK enables vessel preparation for imaging and treatment in a single step without an external power source.
The catheter is now commercially available in Europe and is expected to 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, 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. 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 patient procedures were performed earlier this month at Policlinico Abano in Italy by interventional radiologist Dr. Marco Manzi.
“Crossing a CTO is often one of the most difficult and risky steps of a procedure,” Manzi said. “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.”
FDA clearance and CE marking were supported by the RESTOR-1 pivotal study, which evaluated Santreva-ATK in 70 patients with totally occluded femoropopliteal arteries. The study reported a 90% overall success rate with no device-related major adverse events. A subset analysis of 54 patients suggested the device provided more than 55% mean lumen gain.
“For a long time, CTOs have required safe and simple algorithms to help interventionalists focus on relieving ischemia,” said Dr. Subhash Banerjee, principal investigator of RESTOR-1 and chief of cardiovascular research and innovation at Baylor Scott & White Heart and Vascular Hospital. “Santreva-ATK’s attributes and outcomes enable this goal, while reducing the complexity of endovascular interventions in femoropopliteal arteries.”
AngioSafe said the device is intended to improve outcomes for patients with peripheral artery disease, particularly those with severe stenosis and CTOs, which occur in up to half of symptomatic PAD cases.
