Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for an expanded polytetrafluoroethylene (ePTFE) implant. This Category III medical device is specifically processed and manufactured for the repair or reconstruction of the pericardium during cardiac surgery.
Significance of ePTFE in Cardiac Surgery
Cardiac surgery often results in the loss of the original pericardium, leading to the exposure of the heart surface and adhesion of the sternum tissue post-surgery. Such complications pose a risk of serious issues, including bleeding during subsequent open chest surgeries and increased surgical difficulty. Therefore, the routine implantation of an ePTFE to repair or reconstruct damaged pericardium is essential to protect the heart. Beijing Balance Medtech acquired the product, along with artificial blood vessels and other ePTFE implant devices and materials, through the acquisition of Shenzhen-headquartered Skyland Innovations, Inc. in April 2023.
Potential Impact of the ePTFE Implant in China
The product is anticipated to become the first homegrown cardiac ePTFE implant material in China, marking a significant milestone in the country’s medical device industry. This development not only highlights Beijing Balance Medical Technology’s commitment to innovation but also addresses the need for advanced, domestically produced medical devices in the Chinese market.-Fineline Info & Tech
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