Advertisement
Advertisement
March 28, 2022
Endovastec’s Hyperflex Balloon Catheter Approved in Japan
March 28, 2022—Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec) announced that it has received registration approval from Japan Pharmaceuticals and Medical Devices Agency for the company’s independently developed Hyperflex balloon catheter.
The Hyperflex device, which obtained European CE Mark approval in 2016, is the company’s first product approved for marketing in Japan. Additionally, it is already available in overseas markets in South America and Asia.
According to the company, Hyperflex is intended to assist in the dilation of aortic stent grafts. 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 solution, making it easier and more flexible, stated the company.
Advertisement
Advertisement
