U.S.-based 3D Systems, in collaboration with French medical technology developer Tissium, has developed a 3D-printed solution for treating peripheral nerve injuries, which has now received De Novo approval from the U.S. Food and Drug Administration (FDA). At the core of the innovation is a bioresorbable implant made from a light-activated, elastomeric polymer, fabricated using specialized 3D bioprinting technology.
The device, named COAPTIUM CONNECT, enables sutureless reconnection of severed nerves and is activated using a custom-designed light system. The procedure is atraumatic, requiring no traditional sutures or staples. Tissium contributes the biomorphic, programmable polymers, while 3D Systems provides micron-level additive manufacturing. Together, they enable the creation of mechanically flexible, high-resolution structures that fully degrade in the body.
“This is a significant advancement in patient care,” said Scott Turner, vice president, advanced systems, 3D Systems. “It has been tremendously rewarding to work alongside the talented team at TISSIUM to design a complete 3D bioprinted solution that offers the potential for patients to recover from peripheral nerve damage. I truly believe this will redefine treatment paradigms and offer hope to individuals that have suffered from the effects of nerve damage in regaining their quality of life.”
The printing process is based on 3D Systems’ proprietary “Print to Perfusion” technique, which allows for the production of cell-compatible scaffolds in high resolution that can later be populated with living cells.
3D Systems has been advancing its bioprinting platform for years, including in a partnership with United Therapeutics focused on creating transplantable lung tissue. The current project with Tissium marks another step toward personalized, polymer-based implants.
“Over the past several years, we have made phenomenal progress building upon Chuck Hull’s invention of 3D printing, and pushing its capabilities into new frontiers,” said Dr. Jeffrey Graves, president & CEO, 3D Systems. “Whether in our medical device business through the production of patient-specific implants and surgical solutions, or through the work our regenerative medicine team is doing, 3D Systems is making a profound impact not only on how healthcare is delivered, but on the quality of patients’ lives, and continues to solidify what I believe is an unparalleled role we play in advancing medicine with additive manufacturing applications. This latest accomplishment by TISSIUM, enabled by our unique 3D printing technology, is one more example of how 3D Systems is transforming patient care for a better future.”
The FDA’s approval of this nerve implant is expected to open the door to further applications of additive manufacturing in biological structures.
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