Endovastec’s Balloon Catheter Receives Marketing Approval in Japan

Shanghai MicroPort Endovascular MedTech — also known as Endovastec — has received approval for its Hyperflex balloon catheter from Japan’s Pharmaceuticals and Medical Devices Agency.  

The device, which gained a CE mark certification in 2016, is for use in the dilation of aortic stent grafts for repair of aneurisms. The thermoplastic polyurethane balloon expands the deployed stent graft to improve adherence to the vascular wall and to minimize leaks, the company said.

With an estimated population of 125 million, Japan is a significant market for medical devices.