Recently, the CFDA approved, upon review, the registration of the “Branched aortic stent-graft and delivery system” produced by MicroPort®.
The product, consisted of preloaded covered stent and delivery system, is applicable to the patients with the thoracic aortic dissection proximal crevasse located between the 15mm distal to the left common carotid artery and 20mm distal to the left subclavian artery (LSA) or the patients with dissection torn inversely to the LSA.
The product is subject to integrated main stent and branch stent design, with conventional aorta introduction path, and a brachial artery-femoral artery introduction path is established before advancement of the stent, so that the main stent and branch stent can be advanced simultaneously. The technique, as the first branch-type aorta covered stent approved for marketing, is the domestic initiative and provides new clinical therapy for the patients with thoracic aortic dissection.
Food and Drug Administration will strengthen the post-market supervision of the product to protect the patient from Medical Devices using safety.