Tuesday, March 29, 2022
Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. 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 stent graft 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."