Tissue Regeneration Systems, Inc. ("TRS") today announced that it has received 510K approval from the U.S. Food and Drug Administration for its Cranial Bone Void Filler product, indicated for use in the repair of neurosurgical burr holes. This is first of a family of craniomaxillofacial surgery products being developed by TRS that incorporate the company's novel skeletal reconstruction and bone regeneration technology platform.
The 510K approval process required TRS to meet a high standard of pre-clinical testing and successfully pass a rigorous review by the FDA. "This is a significant milestone for the company," said Jim Fitzsimmons, president and chief executive officer. "With our base material and manufacturing processes now cleared by FDA, the approval pathway for future products can be streamlined," he added. TRS has filed a 510K for its second product, which is currently being reviewed by FDA. Other submissions are in work, according to Fitzsimmons.
Applying a technology platform created at the Universities of Michigan and Wisconsin, TRS is developing advanced skeletal reconstruction implants with unique attributes. They are bioresorbable over time, fully replacing themselves with natural bone. Although their micro-architecture is porous to facilitate bone integration, they can bear load and they are strong enough to support function without need for reinforcement with metal plates. This structural integrity allows them to be used as an alternative to bone harvested from the patient for complex skeletal reconstruction. Using input from patient CT scans, their geometry can be custom constructed. Finally, they are integrated with a proprietary, osteoconductive coating that serves as an excellent substrate for adhesion and local, controlled release of growth factors to enhance bone regeneration.
"To our knowledge, this is first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3D printing," said Fitzsimmons. "This technology is definitely the wave of the future," he added.
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