BellaSeno has announced that a team at Hannover Medical School has successfully used a customized resorbable bone graft substitute using 3D printing.
Prior to his treatment at Hannover Medical School, the patient had undergone eleven surgeries with soft tissue and bone debridement for secondary wound closure, while the radius fracture was only stabilized with a ring fixator. After six further operations and systemic antibiotic treatment for bacterial eradication of the surgical site, a bone reconstruction operation was performed at Hannover Medical School using BellaSeno’s resorbable scaffold in combination with autologous bone grafting from the medullary canal of the femur. The scaffold is based on Resomer, a biodegradable polymer platform from Evonik. The surgery was successful, and after three months the patient showed timely bony integration and adequate elbow function with no signs of wound healing disturbances or clinical signs of infection. The case study was published in the current issue of the Journal of Personalized Medicine.
“As the example of the 46-year-old patients demonstrates, sophisticated solutions to treat large bone defects are scarce. BellaSeno’s scaffold enabled us to conduct a new surgical technique for graft vascularization by embedding a vascular muscle arcade directly into a patient-specific, 3D-printed bioresorbable scaffold,” said Prof. Dr. med. Philipp Mommsen, Managing Senior Physician, Clinic for Trauma Surgery at Hannover Medical School and lead author of the paper. “This surgical procedure represents an innovative and promising approach for the restoration of extensive bone defects. As we see an increasing number of such catastrophic and very difficult to treat defects we are facing a rapidly growing medical need to reconstruct such injuries.”
The scaffold was designed by BellaSeno as a customized cage structure to perfectly fit the patient’s anatomy and ensure a secure hold of the autologous bone graft in the large cavity. For reconstructive surgery, specific design features have been incorporated to allow placement of an arteriovenous loop or central vascular pedicle. The scaffold was manufactured in BellaSeno’s proprietary AI-driven additive manufacturing facilities using a no-touch approach.
“The sheer size of such defects and the lack of vascularization have limited the optimal treatment of large-volume bone defects,” said Priv. Doz. Dr. med. Tobias Grossner, CMO of BellaSeno. “Using one of our scaffolds, the outstanding team at Hannover Medical School was able to perform the reconstruction of such an extensive radial shaft bone while ensuring immediate vascularization. This demonstrates the power of our technology to improve the surgical treatment of large bone defects, individually customized to the specific anatomy of the patient and the design preferences of the surgeon.”
“This case study once again underlines the versatility of our technology,” said Dr. Mohit Chhaya, CEO of BellaSeno. “Almost any design request by a medical team can be fulfilled to optimize the patient’s treatment. The open structure of the scaffold enables vascularization which is crucial not only for proper bone healing but also to allow access of immune cells and anti-microbial drugs to prevent surgical site infections. We are currently working on next-generation bone scaffolds made of a composite of PCL and bio-active glass with anti-infective properties.”
BellaSeno’s MDR-certified manufacturing platform meets the requirements for medical scaffolds from soft tissue to bone and enables the production of both customized and off-the-shelf sterile medical implants, representing a significant advance in the treatment of large bone defects.
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