Valiant Navion – BIBA Medtech Insights

Valiant Navion TEVAR system approved for use in Japan

Valiant Navion Medtronic has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Valiant Navion thoracic endovascular aortic repair (TEVAR) system. Consequently, the company has launched the system in Japan for minimally invasive repair of thoracic descending aortic aneurysms and complicated type B aortic dissections. According [...]

Medtronic receives US FDA Breakthrough Device Designation for complex EVAR device

Source: BIBA MedTech Aortic Segmentation Monitor The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Medtronic for its novel Valiant thoracoabdominal aneurysm (TAAA) stent graft. A press release reports that the device is designed to offer an off-the-shelf solution for complex endovascular aneurysm repair (EVAR) procedures, adding that [...]