AngioSafe Introduces Santreva-ATK Catheter After FDA Clearance and CE Mark Approval

What's Happening?

AngioSafe has announced the launch of its Santreva-ATK Endovascular Revascularization Catheter following FDA 510(k) clearance and CE Mark approval. The Santreva-ATK is designed to simplify complex interventions for patients with peripheral artery disease (PAD), particularly those with severe stenosis and chronic total occlusions (CTOs). The catheter, which is wire-free and does not require external power, aims to make procedures safer and more predictable. The device has been successfully used in real-world procedures in Italy and is set for a U.S. launch in October 2025. The RESTOR-1 pivotal study, which supported the device's approval, demonstrated a 90% success rate with no major adverse events.

Why It's Important?

The introduction of the Santreva-ATK catheter represents a significant advancement in the treatment of PAD, a condition that affects millions of Americans. By reducing the complexity and risk associated with endovascular interventions, the device could improve patient outcomes and expand treatment options. This innovation is particularly crucial for patients with CTOs, which are a leading cause of failed interventions and prolonged procedure times. The catheter's ability to simplify these procedures could lead to broader adoption and potentially lower healthcare costs by reducing the need for more invasive surgeries.

What's Next?

AngioSafe plans to present data from the RESTOR-1 study at the Amputation Prevention Symposium in Europe. The U.S. launch of the Santreva-ATK is scheduled for October 2025, which could lead to increased adoption in American healthcare facilities. The company aims to continue developing its Atheroplasty technology platform to further enhance vascular interventions.