By Fineline Cube 
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that it has received breakthrough devices designation (BDD) from the U.S. Food and Drug Administration (FDA) for its COMETIU self-expanding intracranial drug-eluting stent system and COMEX balloon microcatheter.
System Overview
The COMETIU self-expanding intracranial drug-eluting stent system and the COMEX balloon microcatheter form a comprehensive solution for treating intracranial atherosclerotic stenosis. This integrated system is designed to shorten surgical time and reduce the risks associated with exchange maneuvers.
Regulatory Milestone
COMETIU represents a significant regulatory milestone as the first product globally for the treatment of intracranial atherosclerotic stenosis to receive FDA BDD. It is also the first domestically produced neurointerventional device to achieve this designation. The domestic registration of the product has now entered the review stage.-Fineline Info & Tech