Dymicron Gains CE Mark for New Disc Replacement Device

Dymicron Inc. has received the CE mark for its Triadyme-C cervical total disc replacement (cTDR) device. The company also completed ISO 13485 certification of its quality management system. Triadyme-C is made of Dymicron’s proprietary Diamond material.

“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: minimizing wear, debris generation and emulation of natural constrained motion in the spine.

Dymicron’s biocompatible orthopedic Diamond material is made of polycrystalline diamond compact (PDC) and is a very hard and durable substance. This durability is meant to greatly reduce the structural breakdown that can release dangerous wear 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 centering force that emulates the natural motion of the spine, the company claims.

“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’re 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, M.D., at the American Institute of Minimally Invasive Surgery, were the first in-vivo placement of Dymicron’s cTDR.

Dymiconr is based in Orem, Utah, and makes orthopedic implants made from its proprietary PDC material.