castor™ gained cfda approval2017-云顶国际

shanghai, china - castor™ branched aortic stent-graft system ("castor™"), in-house developed by shanghai microport medical (group) co., ltd ("microport®"), recently obtained the regulatory approval from china food and drug administration ("cfda"). it is the fourth device of microport® that gained the cfda approval through the cfda green path for innovative medical devices.

castor™ is the endovascular device used to preserve the branch artery while repair the thoracic aorta. its unique "unibody design" could accommodate diverse arch anatomy. it is also the world's first branched stent graft system designed for an entirely endovascular treatment of thoracic dissection encroaching the left subclavian artery or the original tear located within 15mm distal to the left subclavian artery and 20mm distal to the left carotid artery. castor™ adopts the "unibody design", which is sewing the main body and branch stent together to make it possible to deploy and release at the same time. this design innovatively accomplishes deployment and positioning of the unibody branched stent graft, achieving low endoleak rate and better branch artery patency, which reduces the operative trauma and improves safety during the procedure. castor™ also employs several unique designs, such as kink-free outer sheath design, soft sheath design with excellent arch crossability, and branch stent sheath.

aortic dilation diseases, in particular aortic dissection, are now commonly seen in china with the increasing incidence of atherosclerosis. aortic dilation diseases are associated with high disability and death rates as they often lead to severe complications such as limb ischemia, visceral ischemia, and paraplegia. it is the emergence of the endovascular repair by stent graft endovascology that largely reduces the operative trauma. though endovascular repair has become the main method to treat aortic dilation diseases, thoracic aortic dissection involving aortic arch branch artery, such as left subclavian artery, is still the relative contraindication of endovascular repair due to lack of suitable endovascular prosthesis. the launch of castor™ marks a significant step forward in using endovascular repair to treat aortic arch, making breakthroughs in a key area clinicians have spent many years to research and explore.