德国医疗设备制造商贝拉塞诺has announced that its proprietary 3D printed breast implants have entered human trials.
贝拉塞诺’s 3D printed breast scaffoldsare fully-resorbable, in that they’re designed to be implanted during breast regeneration, augmentation or revision surgeries, before being slowly absorbed by the body. In an initial trial last year, the firm proved the implant’s efficacy in human applications, hence it has now rolled-out two more trials that’ll see it used to treat chest or breast deformity patients directly.
“This trial is a very important step for us to demonstrate that our approach is not only safe, but leads to substantial improvements in terms of long-term safety, health and quality of life,” said Dr. Tobias Grossner, CMO of BellaSeno. “We very much hope the trials once more confirm our scaffold-guided tissue reconstruction concept.”
贝拉塞诺’s resorbable implants
Working from its bases in Leipzig, Germany and Brisbane, Australia, BellaSeno has come up with a unique biomimetic design platform that enables the 3D printing of clinically-validated resorbable polymers into implants. Designed to serve as an alternative to the complex surgical methods and stem cell-based science behind skin grafts, the firm’s portfolio revolves around itsSenella Breastimplant.
So far, in preclinical studies, the scaffold has proven capable of resorbing around 2-3 years after surgery, and allowing for fat injection from any angle, making it easier for surgeons to use. Compared to the silicone prostheses deployed in more than 70% of breast surgeries, the firm’s implant is also demonstrably over 90% lighter, while its ability to achieve full tissue integration means less risk of complications.
Other products in BellaSeno’s portfolio include theSenella Pectus这是一种用于治疗胸壁缺陷的植入物，其方式并不比传统的Nuss或Ravitch手术那么复杂且风险较小。该公司还销售其3D打印BoneBricbone graft-holding cage, a device that effectively secures implants within bone voids and segmental defects during the healing process.
在过去的三年中，这些产品在终点和商业化的旅程中已经通过了几个里程碑。2019年7月，贝拉塞诺筹集了420万欧元并宣布其植入物已获得ISO 13485 certification。不久之后，贝拉塞诺’s breast implants entered clinical trials使用Evonik恢复材料，此后它进一步发展为人类评估。
进入人类试验以下
Already, recruitment is said to have started for the human trials of BellaSeno’s 3D printed implant in Brisbane, Australia. Sponsored by its Australian subsidiary, BellaSeno Pty, the research program is set to see the company’s breast scaffolds deployed in two different applications, the first of which will see it used to treat ‘pectus excavatum.’
As part of the study, ten sufferers of this congenital chest wall deformity, which causes the breastbone to sink into the chest, will have porous polycaprolactone scaffolds implanted into them. Once inserted in compressed form via minimally invasive surgery, the devices are expected to unfold and merge with patients’ own fat tissue obtained via liposuction, leaving no foreign material traces behind.
在这些试验的第二次试验中，贝拉塞诺（Bellaseno）旨在招募另外二十名需要乳房植入物修订或先天性乳房缺陷手术的患者，这些患者将接受由相同可吸收的缝合材料制成的植入物治疗。
去年，该公司发布了其第一个人类数据，该数据表明其植入物能够以传统技术是不可能的方式掩盖了pectus excevatum缺陷。通过其最新试验，Bellaseno现在旨在进一步评估其脚手架的安全性和不良事件率，以及脂肪体积的变化，软组织保留率及其对患者造成的任何疼痛。
“We are delighted to spearhead the administration of novel, fully-absorbable implants for soft tissue reconstruction applications,” said Dr. Michael Wagels, principal investigator of the pectus excavatum trial. “There is a clear need for a safe alternative to contemporary alloplastic materials and operative techniques in pectus excavatum and breast surgery.”
“Having customizable implants that resorb, leaving behind the patient’s own tissues, is a big step forward.”
Bellaseno只是几个寻求使用3D打印作为优化乳房手术的手段的商业和学术组织之一。科学家在阿桑医疗中心have developed3D printed breast surgery guides, designed to help cancer survivors retain as much breast tissue as possible post-tumor removal.
Elsewhere, in the field of 3D bioprinting,填料and CELLINK are 3D bioprinting breast implants随着时间的流逝，这种方式降低了，以使它们被患者的本地组织取代。尽管纸巾尚未完全达到人类试验阶段，但如果这样做，他们预计将解决28亿美元的市场。
Similarly,愈合型筹集了680万美元今年早些时候朝着自己的3D生物打印乳腺组织。由患者自己的细胞制成，正在开发植入物，以帮助治疗那些接受乳房切除术的妇女，通过为她们提供患者特异性的移植物，而这些妇女不太可能被拒绝。
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特色图片显示了贝拉塞诺（Bellaseno）的3D印刷生物吸收的Senella乳房脚手架。通过Bellaseno的照片。
