Tokyo, Japan, 24 March 2022 — Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™) recently announced that it has received registration approval from Japan Pharmaceuticals and Medical Devices Agency (PMDA) for its independently-developed Hyperflex® Balloon Catheter (Hyperflex®) as the company’s first product approved for marketing in Japan. Hyperflex® obtained CE Mark in 2016 and is already available in overseas markets in South America and Asia.
Hyperflex® is intended to assist in the dilation of aortic stent graft. It uses a compliant TPU balloon to expand the deployed stent graft, which enables improved adherence to the vascular wall, minimizes type I/III endoleaks, and improves stent positioning for better short- and long-term outcomes. When used in conjunction with the aortic stentgraft system, Hyperflex® provides an integrated endovascular aneurysm repair(EVAR) solution, making it easier and more flexible.
Mr. Qing Zhu, President of Endovastec™, stated, "The approval of the Hyperflex® Balloon Catheter in Japan signals a growing acceptance of our EVAR devices in more and more national and regional healthcare systems, paving the way for the company's continued marketing in Asia and the globe. Endovastec™ will continue to innovate to improve solutions for aortic diseases and reach more patients worldwide with better products and services. ”
Founded in Shanghai in 2012, Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. ("Endovastec™", Stock code: 688016.SH), a subsidiary of MicroPort Scientific Corporation ("MicroPort®", Stock code: 00853.HK), is a global medical devices company focusing on R&D, manufacturing, and sales of aortic and peripheral vascular interventional devices, with main products of thoracic and abdominal aortic stent grafts, stent grafts in surgical operation, drug coated PTA balloon catheters, and PTA balloon catheters etc. At Endovastec™, we are breaking barriers and accelerating access to provide trustworthy and universal access to state-of-the-art solutions of prolonging and reshaping all lives, and to build a people centric enterprise ranking as a global leader of evolving and emerging medical technologies through continuous innovation.