World's First Implantation Completed: Dazhou Medical Launches Pivotal Clinical Trial for 3D-Printed Porous Tantalum Lumbar Interbody Fusion Device

Recently, Dazhou Medical collaborated with Renji Hospital, affiliated to Shanghai Jiao Tong University School of Medicine.“3DPrinted Bone-like Porous Tantalum Lumbar Fusion Cage”Post-Market Clinical Trial Reaches Key Milestone——World's First Patient Successfully Enrolled and Completes Implantation. This clinical trial project is guided by renowned orthopedic expert Vice President Yue Bing and Director Qu Xin Hua from Renji Hospital, with Deputy Director Xu Ruida serving as the project leader and chief surgeon, marking a crucial step forward in the clinical transformation of high-end orthopedic implant devices in China.

Project Background:
Renji Hospital is conducting a study on“Effectiveness and Safety of Lumbar Fusion Cage in Lumbar Interbody Fusion Surgery”Clinical trials are planned to recruit participants nationwide in China.50Patients requiring lumbar interbody fusion surgery. This itemThe project has been approved by the hospital's scientific research ethics committee.

Product Advantages:
Lumbar interbody fusion is a common surgical procedure for treating degenerative lumbar diseases, traditionally usingPEEKAlthough the fusion device can restore intervertebral height, its material itself is difficult to achieve bone ingrowth. Developed by Dazhou Medical.3DPrinted porous tantalum fusion device, featuring bionic trabecular bone structure, high porosity, excellent osteoconductivity and osteoinductivity.Effectively promote osseointegration, enhance early stability, and have a lower bacterial adhesion rate.

Innovative Breakthrough:
The fusion device (Registration Certificate No.: National Medical Device Registration Approval20243132044) Not only in the United StatesFDAThe First Approved3DPrinting porous tantalum implants, which is currently the only one in China approved by both China NMPA and the U.S. FDADual-certified3DPrintPorousTantalum Implant Products.TheThe product is based on China's National Key R&D Program, jointly developed by Renji Hospital and Dazhou Medical.DesignDevelopment, marking ChinaMedical DeviceThe enterprise has taken the lead internationally in the research, development, and industrialization of original orthopedic devices.

▲ Source of the article: Dazhou Medical

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