ISO 13485 and CE mark for Dymicron’s Triadyme-C cervical total disc replacement device

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Dymicron’s Triadyme-C cervical total disc replacement (cTDR) device (previously the Tri-Lobe cTDR) has earned its CE mark.

The company has also completed ISO 13485 certification of its quality management system. These certifications will now allow for the marketing and commercialisation of the company’s next-generation Orthopedic Diamond cervical disc in the European Union and other countries around the world that recognise the CE mark approval process.

“This is tremendous news not just for medical professionals, but for patients suffering from degenerative disc disease,” said Jeffrey Bennett, president of Dymicron. “Dymicron’s Triadyme-C is highly differentiated from other discs on the market due to its material composition, superior durability and wear characteristics, and unique emulation of natural spinal motion.”

Triadyme-C will address two immediate areas of concern in the total disc replacement field– minimising debris generation and emulating the natural constrained motion in the spine.

Dymicron’s biocompatible Orthopedic Diamond material is made of polycrystalline diamond compact, one of the hardest and most durable substances in the world. With extreme durability and a low coefficient of friction, Triadyme-C resists the structural breakdown that can release dangerous debris into the body.

The proprietary tri-lobe technology developed by Dymicron features an articulation mechanism made of three spherical lobes seated within three non-congruent, spherical pockets. The motion of the three lobes within their associated pockets generates a smooth, gentle centring force that emulates the natural motion of the spine.

“With its natural motion design and Orthopedic Diamond material, we feel like Dymicron can make an immediate impact in the cervical disc replacement market. Based on our technology and design, we are confident we can provide a great option to patients suffering from degenerative disc disease and become the leader among the next generation of cervical disc replacement devices,” added Bennett.

Dymicron recently confirmed the successful implantation of the Triadyme-C in two patients. The surgeries, performed by William Smith at the American Institute of Minimally Invasive Surgery, were the first in vivo placements of Dymicron’s cTDR.