The combination of bioresorbable plastics and 3D printing are becoming critical players in the fast-emerging field of tissue engineering.
In a recent development, Tissue Regeneration Systems (Kirkland, WA) received 510K approval from the U.S. Food and Drug Administration to use its Cranial Bone Void Filler product in the repair of neurosurgical burr holes. It wll be the first use of the technology licensed from the Universities of Michigan and Wisconsin.
"This is a significant milestone for the company," said CEO Jim Fitzsimmons. "With our base material and manufacturing processes now cleared by FDA, the approval pathway for future products can be streamlined." Other submissions are in the pipeline.
Porous scaffolds made of polycaprolactone (PCL) are bioresorbable and are replaced over time with natural bone. That's a big advantage over metal, which requires a second surgery for removal. Other techniques, such as bone grafts are also falling out of favor....