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A Novel Puncturable Atrial Septal Defect Occluder: The Results of Preclinical Experiment and First-in-Human Study
Xiaochun Zhang1, Shasha Chen1, Wei Li2
1Department of Cardiology, Shanghai Institute of Cardiovascular Disease, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai, China.
Abstract:
ReAces is a novel puncturable transcatheter atrial septal defect occluder. The device success rate was 100% (n = 14 of 14) in the animal experiment. Four swine successfully received puncture of the device 60 days after implantation of the device. The acute procedure success rate in the 10 patients was 100%. Transthoracic echocardiography examination showed that the devices were well positioned with no residual shunt, and the area of central portion of occluder was substantially thin. It is safe and effective to use ReAces for closure of secundum atrial septal defect, and puncture the atrial septum at the portion of the device is feasible.
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