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Shanghai, China—Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec?) recently received a registration certificate from China’s National Medical Products Administration (NMPA) for its independently developed Talos? Thoracic Stent Graft System (Talos?). 

Talos? was approved to enter NMPA's special approval process for innovative medical devices in 2017. It was selected as a project under the 2017 Shanghai Special Support Program for Biomedical Science and Technology. It was also enteredas a special project in Pudong New Area Science and Technology Development Fund for bringing together films, universities and research institutes in China.

Talos? is an innovative stent graft system for treating aortic dissection, which is an acute cardiovascular disease. In the aortic lumen, a false lumen is formed when blood enters the aortic tunica media from a rupture at the aortic tunica intima. When subjected to prolonged blood impact, the false lumen will expand or even rupture, causing aortic dissection. 

Mr. Qing Zhu, President of Endovastec?, said, “We are excited to welcome another independently developed product of Endovastec? and obtaining marketing approval through ‘Green Path’. In 2021, new products such as the Fontus? branced stent graft system in surgical operation and the Talos? thoracic stent graft system have entered the market, further enriching our existing aortic portfolio. In the future, we will continue to enhance our core competitiveness by focusing on unmet clinical demands, accelerating technological innovation, and improving product diversification.”

Thoracic endovascular aortic repair (TEVAR), which features minimally invasive, short surgical time and fast recovery, significantly reduces the difficulty and mortality of traditional open surgeries, and hence is increasingly used in treating aortic dissection, making it the technique of choice for Stanford type B aortic dissection.

Talos? is designed with microperforation at the distal end created by laser forming technology to ensure the patency of distal branch vessels of the descending aorta after endovascular graft exclusion, which in turn reduces the incidence of spinal cord ischemia for the benefit of patients. The maximum available length of Talos? is extended to 260 mm, which not only allows for a longer segment coverage of the lesion but also makes it easier to prop open the true lumen to ensure aortic remodeling. Its innovative delivery system features step-by-step release technology that enables the successive release of the sheath, the stent graft, and the bare stent, ensuring targeted and precise release of the stent graft in with more stability.

Clinical study results have shown that Talos? has good safety and efficacy profiles, with more favorable performance in terms of the incidence of aortic remodeling and spinal cord ischemia when compared with data from previous clinical research.