Two Occluder Devices Received SFDA Re-registrations
MicroPort Scientific Corporation (HK: 00853) announced that one of its subsidiaries, Dongguan Kewei Medical, has received SFDA approval on two occluder devices: duct occluder (SFDA, 2013 No. 3770019) and atrial septal defect occluder (SFDA, 2013 No.3771706). These approvals again demonstrated MicroPort's commitment to improving patient quality of life through continuous innovation in minimally invasive medicine.
The septal occluder device is a transcatheter closure device used to treat atrial septal defect (ASD). It consists of Nitinol wire mesh discs filled with alloy grid and 316L stainless steel and polyester film sterilized by ethylene oxide. The device blocks a hole in the wall of a heart and is designed with an umbrella-type design which is folded up until the catheter arrives at the area of the defect in the heart. Once in place the occluder is unfolded on both sides of the defect so that pressure from both sides keeps it in place.
According to the statistics, the potential patient population in China with congenital heart diseases has reached 2 million and increases at the rate of 200,000 annually. Prior to the advent of percutaneous techniques, surgical closure was the only treatment option for an ASD, regardless of the type of defect. The introduction of MIS with occulder provided patients with a less-invasive alternative to surgery and also improves quality of life.
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