中国首款！PEEK长丝3D打印的颅骨修补假体获批上市

Core Viewpoint - The article highlights the approval of a patient-matched cranial repair implant developed by Evonik in collaboration with Tianjin Kang'er Medical Devices Co., marking a significant advancement in the application of FDM (Fused Deposition Modeling) technology in medical devices [1][2]. Group 1: Product Development and Approval - Evonik's cranial repair implant is the first personalized cranial repair prosthesis in China based on FDM technology, receiving official approval from the National Medical Products Administration (NMPA) [1]. - The product utilizes bone-integrating PEEK filament VESTAKEEP® Fusion iC4800 3DF, showcasing a breakthrough in the use of FDM technology for implantable medical devices [1]. Group 2: Material Properties and Clinical Benefits - PEEK material offers biomechanical properties that align with clinical needs, providing long-term stable protection for brain tissue [1]. - The design allows for complex porous structures and personalized anatomical shapes through 3D printing, ensuring a perfect fit for patients' cranial defects [1]. - The biocompatibility of PEEK significantly reduces surgical complexity and postoperative rejection risks, enhancing patient experience and quality of life [1]. Group 3: Industry Impact and Future Prospects - The introduction of the cranial repair implant signifies a leap into the "precision fusion" era for cranial repair in China, reflecting local advancements in PEEK material modification and application processes [2]. - Evonik's PEEK materials are positioned as key to unlocking the potential of additive manufacturing in the medical device sector, with a diverse product line that includes carbon fiber-reinforced PEEK filaments [2].