Recently, the Cratos™ Thoracic Branch Stent Graft System (Cratos™), developed by Endovastec™, has achieved certification as a Custom-Made Device (CMD) in the EU.

Cratos™ is an advanced version of Castor™, Endovastec™’s flagship stent graft. Castor™ was the world’s first branched aortic stent graft designed specifically for endovascular treatment of thoracic aortic dissections involving the left subclavian artery. Building on this, Cratos™ offers improved performance and a more refined surgical experience. Like its predecessor, Cratos™ retains the integrated branched structure but introduces innovations in its delivery system, including a new small-bend posterior release technique and an adjustable proximal stent end, which improve positioning accuracy and reduce the bird-beak effect. Additionally, the outer sheath has been reduced to a 22F diameter, minimizing vascular access requirements and expanding potential applications. Other features, such as a longer outer sheath, a rapid-release rotational mechanism, and an error-prevention release system, further streamline the surgical procedure.

Cratos™ also delivers significant advancements for treating thoracic aortic aneurysms compared to Castor™. The device introduces a unique tip capture technology for the lesser curvature of the aorta, as well as active proximal stent control, reducing the of Type I endoleak cause by inaccurate positioning. As thoracic aneurysm surgeries outnumber aortic dissections in Europe, Cratos™ is expected to drive substantial growth in the regional market for branched stents.

Certification as a Custom-Made Device in the EU represents a pivotal milestone for Cratos™, enabling earlier patients access to this cutting-edge product. Pre-market clinical trials for Cratos™ are already underway, with successful implantations completed in Switzerland and Spain. The outcomes of these trials will support future applications for CE certification in the EU and PMDA approval in Japan.

Endovastec™ remains committed to delivering accessible, high-quality solutions for circulatory diseases and will continue to advance integrated solutions for aortic and peripheral vascular diseases worldwide.