Source: Bone Future; Editor: Seven Kite
Reprint Requirements: You can directly repost, but please credit the source at the beginning of the article.February 10, 2025Susheng Biotech("Susheng Biotech" for short)Introduced from Switzerland"Polyester Collagen Bone Repair Material" Obtained the Class III Medical Device Registration Certificate issued by the National Medical Products Administration.
【Registration Certificate Number】China Medical Device Registration No. 20253130077
[Structure and Composition]This product is composed of bovine-derived cancellous bone (98.5±0.5%), poly-L-lactide-co-ε-caprolactone (1.0±0.2%), and gelatin (derived from porcine, 0.5±0.1%). The polymer of poly-L-lactide-co-ε-caprolactone contains 70% L-lactide and 30% ε-caprolactone. The product is in block or granular form, sterilized with ethylene oxide, with a sterilization validity period of 4 years, and is for single use.
[Scope of Application]Suitable for filling and repair of bone defects.
As early as July 29, 2023,"Polyester Collagen Bone Repair Material" has already been approved through the Boao Lecheng "Pilot First" policy., at Ruijin Hospital Hainan Branch (Boao Research Hospital), affiliated to Shanghai Jiao Tong University School of MedicineCompleted the first clinical application in China。
# Scarcity and Importance of Bone MaterialsAccording to "Research Progress and Clinical Application of Allogeneic Bone Materials",China performs more than 500,000 bone graft surgeries annually, making bone the second largest transplanted tissue after blood.。For a long time, autologous bone has been the gold standard for bone defect grafting materials. However, when patients require large-area bone grafts, autologous bone often cannot meet the needs of transplantation. In such cases, allogeneic bone is usually used. As the name suggests, allogeneic bone comes from another person's body. Its sources are limited and accompanied by strict legal and ethical regulations. Besides autologous and allogeneic bones, artificial bone materials have also been commonly used in bone graft surgeries in recent years. However, an ideal artificial bone material has yet to emerge.The Risk of Secondary Surgery for Revision in Artificial Bone Grafts。The certification and market launch of "Polyester Collagen Bone Repair Material" will greatly fill the gap in China's bone material field, providing a better solution for bone graft surgeries.
# Next-Generation Frontier Bone Regeneration Materials"Polyester Collagen Bone Repair Material" is a new type of composite bioactive bone substitute, specifically developed for bone regeneration in reconstructive surgery. It is suitable for filling and repairing bone defects in non-load-bearing areas of the limbs.
"Polyester Collagen Bone Repair Material" isMade by combining bovine mineral bone matrix with biodegradable absorbable polymers and collagen fragments.This novel composite biomaterial promotes rapid cell ingrowth into orthopedic substitutes while being biocompatible.Things are also progressing gradually.Degradation, providing integration and osteogenesis, thereby achieving final remodeling.
# Superior Bone Material PropertiesThe microstructure of "polyester collagen bone repair material" is very similar to human bone in terms of open, interconnected, and medium-sized porosity, which ensures crucial, functional integration of bone implants. It will be absorbed and replaced by the patient's own bone within 1-2 years.Biodegradable polymers allow "Polyester Collagen Bone Repair Material" to withstand a maximum load three times that of similar products, with rigidity four times greater, high volumetric stability (>95%), and protection of bones from early resorption.
High Hydrophilicity and High Tissue Integration
Collagen fragments enable "polyester-collagen bone repair material" to rapidly achieve an average swelling of 38% w/w, promoting blood cell adhesion and colonization, thereby enhancing the chemical cascade signaling that promotes the overall osteogenic process.
# 3D Customization of Polyester Collagen Bone Repair MaterialsThe high mechanical strength of "Polyester Collagen Bone Repair Material" enables it to support 3D customization. Unlike common 3D printing, "Polyester Collagen Bone Repair Material" adopts a subtractive manufacturing method.Retain the excellent osteogenic activity of the material, based on CT data scanning and 3D modeling design, produced by cutting, CNC machining, and other subtractive manufacturing processes from a solid block of material.Can perfectly match the damaged area of the patient, ensuring an ideal integration between the graft and the recipient's injured site.。The "Polyester Collagen Bone Repair Material" customized with 3D technology achieves precision and personalization, ensuring a perfect match between the graft and the recipient, and helping patients quickly address special bone defects.
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