南宫NG·28(中国)相信品牌力量

Recently, The Cratos™ Branched Aortic Stent-Graft System (Cratos™), developed by Endovastec™, completed its first pre-market implantation at the University Hospital Zurich in Switzerland, as the starting of its CREATION clinical study. This study is instrumental for approval applications in the EU and Japan.

The implantation was completed by Professor Alexander Manuel Zimmermann and his team. The 56-year-old patient was diagnosed with acute Type B aortic dissection, with the dissection entry tear located near the opening of the Left Subclavian Artery (LSA). The conventional straight tube stent did not provide a sufficient landing zone, whereas Cratos™ extended the landing zone, isolating the lesion while preserving LSA blood flow. The procedure went smoothly. Despite the dissection entry tear being close to the LSA opening, postoperative angiography showed complete exclusion of the tear without any endoleak and patent LSA blood flow. The implantation took less than 30 minutes and the patient was discharged safely thereafter.

As the principal investigator of the CREATION study, Professor Zimmermann stated: "Cratos™ has significant performance improvements over its predecessor, the Castor™ Branched Aortic Stent-Graft and Delivery System (Castor™ Branched Stent-Graft). A reduction of 2F in the outer diameter of the delivery system has made the system easier to introduce. In particular, the new sheath design simplifies the unwinding of the branch guidewire and positioning of the branch stent, reducing the manipulations inside the vessel during system positioning, which helps shorten the procedure time."

Cratos™ successfully completed its pre-market clinical implantation in China last year, with good follow-up results. Registration materials were recently submitted to the NMPA. Building on this success, the CREATION study is designed as a prospective, multicenter, single-group target value study aimed at assessing the efficacy and safety of Cratos™ in treating thoracic descending aortic lesions involving the LSA.

Dr. Qing Zhu, President of Endovastec™, commented: "The official commencement of the CREATION clinical study abroad for Cratos™ marks another important milestone in the global development process of Endovastec™. The study not only assists in gaining market access for this innovative product in Europe and Japan but also provides clinical evidence of its application across different ethnicities, thereby facilitating its promotion in global markets and benefiting more patients."

About Cratos™

Cratos™ is an upgraded product launched by Endovastec™ based on the Castor™ Branched Stent-Graft. The Castor™ Branched Stent-Graft, as the world's first approved branched aortic stent graft, was launched in China in 2017, received CMD custom permission in Europe in 2022, and has entered clinical use in 18 countries globally, successfully treating over 20,000 patients worldwide. It has become the preferred device for treating Stanford Type B aortic dissections involving the arch branches.

In terms of stent graft, Cratos™ inherits the integrated branch structure design of the Castor™ Branched Stent-Graft, significantly expanding the stent landing zone while effectively reconstructing the LSA. In terms of its delivery system, Cratos™ has undergone several innovative upgrades: employing a new inner curvature control release technique; integrating an active stent proximal adjustability feature (enhancing the accuracy of stent positioning and eliminating the “bird-beak” at the stent proximal end for better adherence); reducing the sheath diameter of the stent system to 22F (further lowering the requirements for the access vessels, thereby expanding the range of application); and incorporating a longer sheath, rotating plus quick-release method, and misuse-proof design, simplifying the surgical steps.