A 3D printed bone graft from medical device manufacturerCerhum已获得批准用于整个欧洲的患者。
MyBone is reportedly the first commercially available 3D printed bone graft authorized under the Medical Device Regulation 2017/745, and has also been ISO 13485 certified. As a result, the patient-specific bone graft will now be made available to maxillofacial and orthopedic surgeons throughout the continent.
GrégoryNolens，Cerhum创始人和CSO说：“我们很荣幸能成功收集重要的临床数据，并以安全有效的合成骨移植物通过了所有调节障碍。”
3D打印上颌面植入物
Additive manufacturing is being increasingly leveraged for maxillofacial surgeries in the form ofguides that enhance patient outcomes以及最近，用于创建可以植入患者头骨的面部移植物。
例如，魁北克工业研究中心(CRIQ) is3D打印患者特异性下颌植入物, while researchers at保利斯塔大学有3D printed a facial prostheticfor a Brazilian cancer survivor. Meanwhile, earlier this year,Health Canadaapproved its first Canadian-made3D打印的医疗植入物用于口腔癌患者的面部重建手术。
In May, a group of Korean researchers carried out a retrospective study to verify the effectiveness and safety of3D printed titanium implants on maxillofacial bones。16个病人的研究中观察到的结果ith various maxillofacial defects, with almost all of the implants showing satisfactory treatment outcomes.
The MyBone bone graft
Cerhum（人类陶瓷）成立于2016年，是比利时国家科学技术研究所的旋转Sirris。与University of Liège, the company’s goal is to replace autografts – bone taken from elsewhere in the patient’s body – with its synthetic 3D printed alternative.
To date, the firm has 3D printed tens of thousands of synthetic bone grafts that have been used by a range of companies within orthopedic implants.
Mybone是一种患者特异性的3D印刷骨移植，旨在治疗患有严重面部畸形的患者。移植物是由羟基磷灰石制成的，羟基磷灰石是一种磷酸钙，是天然骨的主要矿物质成分，其3D印有独特的多孔结构，以鼓励骨骼生长。
“Our 3D printed bone implants offer a unique, patented porous structure that allows ingrowth of blood vessels,” said Nolens. “This process, called vascularization, is key to achieving successful bone ingrowth. As a result, MyBone has shown seven times faster bone ingrowth than currently available bone graft granules.”
Mybone现在已根据《 2017/745医疗设备法规》（Medical Device Archulation）在欧洲患者中使用，并已在比利时主管当局注册。骨移植物也经过ISO 13485认证，因此，外科医生现在可以作为颌面外科手术的患者特异性植入物使用。
作为两年前受控释放阶段的一部分，根据最近的CT扫描，据报道，该患者现在收到了一个甲状管移植物植入物，现在看起来完全像天然骨头。
“Given the complexity of the defect, it would have been impossible to achieve such perfection from an aesthetic point of view and such a functional result with current methods,” explained Dr. Christophe Ronsmans, Head of the plastic surgery department at CHR Liege.
The patient is said to be doing “excellently” and the success of the surgery has helped pave the way for MyBone’s commercial availability in Europe.
“Due to extremely positive feedback of maxillofacial surgeons so far, Cerhum is expanding its portfolio into the dental and oncological market,” Nolens added.
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Featured image showsCerhum的Mybone 3D打印的面部骨移植。通过Cerhum图像。
