FDA grants Nexus aortic arch stent graft system breakthrough ... | 合法醫療器材資訊網

2020年4月21日—Nexusstentgraftsystem(Endospan).EndospanwasrecentlygrantedbreakthroughdevicedesignationfromtheUSFoodandDrug ...

Endospan was recently granted breakthrough device designation from the US Food and Drug Administration (FDA) for the Nexus aortic arch stent graft system.

The FDA’s breakthrough device designation programme is intended to provide timely access to medical devices that have the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases or conditions by prioritising review of its regulatory submissions, thereby expediting the device development process.

The designation of Nexus aortic arch stent graft system as a breakthrough device acknowledges the unmet need in this patient population and the potential for improvements over current standard treatments.

Minimally invasive techniques are standard-of-care for tre...