Shanghai, China, 4 January 2023 — Endovastec™ has received registration approval from the Ministry of Food and Drug Safety of Korea (MFDS) for its independently developed Minos® Abdominal Aortic Stent-Graft and Delivery System (Minos® Stent Graft System). This is the first time the Minos® Stent Graft System has received marketing approval in an overseas market in Asia. The Minos® Stent Graft System was approved for marketing in China in 2019 and received the CE marking in the same year. Since its approval, the Minos® Stent Graft System has been available in 14 markets, including China, Greece, the United Kingdom, Poland, Germany, Brazil, and Argentina.
As a next-generation abdominal aortic stent graft system independently developed by Endovastec™, the Minos® Stent Graft System is designed for the interventional therapy of subrenal abdominal aortic aneurysms. It is the first stent graft system developed in China that features an ultra-low profile delivery system with an outer diameter as low as 14F, a breakthrough technology that has significantly reduced vessel access requirements during surgery. The stent is designed as a three-piece kit, allowing for flexible in vivo assembly to maximize lesion coverage. It offers distinct benefits in treating complex abdominal aortic aneurysm conditions such as tortuous or short aneurysm neck, and distorted and narrow access, among others. Since its launch, the Minos® Stent Graft System has earned widespread acceptance from experts in the field of vascular surgeries, both domestically and abroad, thanks to its consistent clinical performance and excellent treatment results.
South Korea is a major importer of medical devices in Asia and the market for these products has been growing rapidly in recent years. It is currently one of the top four markets in Asia in terms of market size. In early August 2022, Endovastec™ successfully passed the review process administered by MFDS and obtained the Korea Medical Device Quality System (KGMP) certification, paving the way for its products to access the Korean market. The approval of the Minos® Stent Graft System in South Korea is an important first step for Endovastec™ to enter the Korean market. It is expected to provide a solid boost to Endovastec™'s efforts to further develop its presence in the Asian market and broaden its global reach.
Founded in 2012, Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™; SSE: 688016), an associated company of MicroPort Scientific Corporation (MicroPort®; HKEX: 00853), is a global medical device company focusing on R&D, manufacturing, and commercialization of aortic and peripheral vascular interventional devices. Its product portfolio includes thoracic and abdominal aortic stent grafts, intraoperative stents, drug-coated PTA balloon catheters, and PTA balloon catheters. At Endovastec™, we are breaking barriers and accelerating access to provide trustworthy and universal access to state-of-the-art solutions for prolonging and reshaping life, and to build a people-centric enterprise as a global leader of evolving and emerging medical technologies through continuous innovation.
More information is available at https://microport.com/news.