Release date: 2009-04-29
Recently, Professor Zhang Zhiwei, an academician of the American College of Cardiology and deputy director of the Guangdong Institute of Cardiology, said that because of the possibility of allergic reactions to nickel in nickel metal materials used for interventional treatment of congenital heart disease, safer ceramic materials are expected to replace Nickel metal.
Traditional congenital heart occluders are mostly made of nickel-titanium alloy materials. Zhang Zhiwei said that medical metal materials usually have good corrosion resistance, but the human environment is a complex physiological medium, and medical metal materials are inevitably corroded in the human body. Clinical studies have shown that nickel ions may be harmful to allergies, and researchers are exploring the use of ceramic materials instead of nickel.
According to reports, ceramic membrane sealing technology began clinical trials overseas in 2006. So far, there have been more than 1000 successful implants. In China, ceramic membrane occlusion devices have also undergone large-scale randomized, multi-center clinical trials. Among them, a clinical trial of a ceramic membrane occluder with a sample size of 432 was carried out by 11 clinical medical centers such as the Guangdong Provincial People's Hospital. All patients were enrolled in April 2009. The trial is the largest multicenter, randomized, congenital heart disease interventional device clinical trial ever conducted in China. As of now, no major complications have occurred in clinical trials.
Congenital heart disease vascular disease, referred to as congenital heart disease, is one of the most common congenital malformations. Children with congenital cardiovascular disease often have difficulty in feeding and malnutrition, and are prone to repeated lung infections. Shanghai Medical Device Industry Association
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