hyperflex® balloon catheter by endovastec™ receives marketing approval in japan2022-云顶国际

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. ”