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Straight-tube thoracic aortic stent-graft system approved for marketing

2022-01-25

Recently, the State Drug Administration approved the registration of the innovative product "straight-tube thoracic aortic stent graft system" produced by Shanghai MicroPort Cardiovascular Technology (Group) Co., Ltd.


The product consists of a self-expanding stent graft and a delivery system. The covered stent is made of polyester membrane sutured with multiple self-expanding nickel-titanium alloy stent segments through polyester sutures. The distal end of the covered stent is designed with a perforated covering to open the true aortic lumen and facilitate the remodeling of the aorta. At the same time, the patency of the distal branch vessels can be maintained to reduce the incidence of paraplegia caused by postoperative spinal cord ischemia. In addition, the large-tapered stent-graft design can better conform to the tapering shape of human blood vessels. The delivery system of this product is composed of conical head, inner tube, outer tube, handle and other parts, which are used to realize the introduction and release of the stent graft in the human body. The low outer diameter of the delivery system reduces the diameter requirements of the system access vessel, making it easier to push the stent to the diseased vessel, reducing surgical trauma and complications due to lower extremity ischemia risks.


This product is used to treat patients with Stanford type B aortic dissection and is expected to benefit more patients with aortic dissection.


The drug supervision and administration department will strengthen the post-market supervision of the product to protect the safety of patients using the device.


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