Endovastec today announced it received registration approval from Japan Pharmaceuticals and Medical Devices Agency for its Hyperflex balloon catheter.
The Shanghai-based heart device maker designed Hyperflex to assist in the dilation of aortic stent graft. It is the company’s first device approved for marketing in Japan. Hyperflex previously gained CE mark approval in 2016 and is available in South America and Asia.
Hyperflex has a compliant TPU ballon to expand the deployed stent graft to improve adherence to the vascular wall. It minimizes type I/III endoleaks and improves stent positioning for better outcomes, according to the company. The device can be used in conjunction with the aortic stent graft system for an integrated endovascular aneurysm repair (EVAR) solution.
“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,” Mr. Qing Zhu, president of Endovastec, said in a news release.