Dec 7, 2015 | By Kira

Tracheobronchomalacia (TBM) is a life-threatening condition in which the patient’s airway can become narrow or even collapse during coughing or breathing. Though known to occur in adults, it also affects 1 in 2,220 babies and infants, for whom the life-saving surgery required is extremely difficult and risky. In 2013, doctors of the University of Michigan created a groundbreaking, bioresorbable 3D printed tracheal splint to save a six-week-old baby’s life, and since then, 3D printing technology has played a critical role in saving the lives of several more young children affected by this condition.

Now, in an effort to make 3D printed splints available to more children in need and to push this life-saving use of 3D printing technology, Materialise and Tissue Regeneration Systems (TRS), a startup medical device company that specializes in breakthrough skeletal reconstruction and bone regeneration technology, have announced a partnership to manufacture 3D printed tracheal splints for use in clinical trials.

Founded in 2007, Michigan-based TRS has been working to commercialize their skeletal reconstruction and bone generation technology platform, which leverages 3D printing technology and is based on research conducted at the Universities of Michigan and Wisconsin. TRS’ Scaffold Technology utilizes scalable 3D printing methods to fabricate advanced skeletal reconstruction implants (including the tracheal splints) that are bioresorbable, meaning they replace themselves with natural bone and leave no residuals in the patient’s body. Furthermore, they do not require any metal screws for attachment, and can bear load without the need for reinforcement with metal plates. Through patient-specific CT scans, they can also be custom constructed, and if necessary, they can even be adapted in the operating room to exactly replicate the patient’s missing bone anatomy. All of these properties make them exceptionally well suited to the specific needs of babies and small infants suffering from TBM.

TRS Scaffold Technology

Materialise’s Mimics Innovation Suite was used to design the tracheal splints. The Suite consists of set of tools developed specifically for 3D printing biomedical applications, including Mimics, software for medical image segmentation and 3D model creation; PROPLAN CMF, software for cranio-maxillofacial surgical planning; engineering services; and of course, tangible, accurate and realistic anatomical models produced through Materialises’ 3D printing services.

“The collaboration between TRS and Materialise will provide production capacity for the tracheal splint, which will allow the splint to be available to a larger number of infants who are affected with TBM,” said Bryan Crutchfield, Managing Director of Materialise USA. “We are excited to have the opportunity to impact the lives of children affected with TBM through the production of the tracheal splint,” added TRS CEO Jim Fitzsimmons.

Materialise's Mimics Innovation Suite "Engineering in Anatomy" workflow

TRS’ technology has been evaluated in large animal studies with promising long-term results, and the company has completed all required bench and animal testing, and even received 510K approval from the FDA, clearing their technology platform and their first product for commercialization in the US. The company’s business model relies solely on corporate partnerships, and this most recent collaboration with Materialise is one of several co-development projects underway to rapidly develop and capitalize on their technology platform.

Kaiba Gionfriddo after receiving the 3D printed tracheal splint

Having read the stories of Kaiba Gionfriddo, the first baby to receive a 3D printed tracheal splint, 18-month-old Garett Peterson, as well as three more tracheobronchomalacia–affected children who were treated through 3D printed splints by University of Michigan doctors Glenn Green and Glenn Hollister, it is clear that this is an important application of 3D printing technology that could potentially save hundreds more lives in the near future. Thanks to this partnership between Tissue Renegaration Systems and Mateiralise, we hope to see it grow and eventually reach every child whose life may very well depend on it.



Posted in 3D Printer Company



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